Clinical trial NCT04778397
Conditions: Acute Myeloid Leukemia
Sponsor: Gilead Sciences
Start date: 2021-07-01; Completion date: 2024-03-25
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

Detailed description:

Arms: arm 1: Participants will receive an escalating dose of magrolimab and a fixed dose of azacitidine. arm 2: Participants who are appropriate for non-intensive therapy will receive an escalating dose of venetoclax and a fixed dose of azacitidine. arm 3: Participants who are appropriate for intensive therapy will receive 7+3 chemotherapy: 7 day treatment with cytarabine and 3 day treatment with daunorubicin or idarubicin during induction and high-dose cytarabine and steroidal eye drops during consolidation.
Interventions: intervention 1: Magrolimab intervention 2: Venetoclax intervention 3: Azacitidine intervention 4: Cytarabine intervention 5: Daunorubicin intervention 6: Idarubicin intervention 7: Steroidal Eye Drops
Intervention descriptions: intervention 1: Administered intravenously (IV). intervention 2: Administered orally at a dose of 100 milligrams (mg) on Day 1, 200 mg on Day 2, 400 mg on Days 3-28 during Cycle 1, followed by 400 mg on Days 1-28 during every cycle (Cycle=28 days). intervention 3: Administered either subcutaneously (SC) or IV, 75 milligrams per square meter (mg/m\^2) on Days 1-7 or Days 1-5, 8 and 9 during every cycle (Cycle=28 days). intervention 4: Induction: administered continuous infusion, 100 or 200 mg/m\^2 on Days 1-7 (7+3 induction) and if needed Days 1-5 (5+2 induction) during a cycle (Cycle=Up to 42 Days).

Consolidation: administered IV, 1500 or 3000 mg/m\^2 on Days 1, 3, and 5 once every 12 hours for up to 4 cycles. intervention 5: Administered IV peripherally (IVP), 60 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days). intervention 6: Administered IV, 12 mg/m\^2 on Days 1-3 (7+3 induction) and if needed Days 1-2 (5+2 induction) during a cycle (Cycle=Up to 42 days). intervention 7: Administered per institutional standard during consolidation.

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 3, Randomized, Open-Label Study Evaluating the Safety 
and Efficacy of Magrolimab in Combination with Azacitidine 
versus Physician’s Choice of Venetoclax in Combination with 
Azacitidine or Intensive Chemotherapy in Previously Untreated 
Patients with TP53 Mutant Acute Myeloid Leukemia
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
USA
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
147229
2020-003949-11
NCT04778397
Indication:
Acute Myeloid Leukemia
Protocol ID:
GS-US-546-5857
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol Version/Date:
Original:
21 September 2020
Amendment 1:
16 February 2021
Amendment 2:
28 April 2021
Amendment 3:
09 August 2021
Amendment 4:
31 March 2022
Amendment 5:
02 November 2023
This study will be conducted under United States Food and Drug Administration investigational 
new drug (IND) regulations (21 Code of Federal Regulations Part 312); however, sites located in 
the European Economic Area, United Kingdom, and Switzerland are not included under the IND 
and are considered non-IND sites.
CONFIDENTIALITY STATEMENT
The information contained in this document, particularly unpublished data, is the property or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable 
institutional review board or independent ethics committee. The information is only to be used 
by you in connection with authorized clinical studies of the investigational drug described in 
the protocol. You will not disclose any of the information to others without written 
authorization from Gilead Sciences, Inc., except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered.
(rJ GILEAU 


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................6
LIST OF IN-TEXT FIGURES........................................................................................................................................7
PROTOCOL SYNOPSIS................................................................................................................................................8
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................................23
1.
INTRODUCTION................................................................................................................................................26
1.1.
Background..............................................................................................................................................26
1.2.
Magrolimab .............................................................................................................................................27
1.2.1.
General Information ..............................................................................................................27
1.2.2.
Nonclinical Pharmacology and Toxicology ..........................................................................28
1.2.3.
Clinical Background for Magrolimab ...................................................................................28
1.3.
Information About Venetoclax and Azacitidine......................................................................................30
1.3.1.
Description of Venetoclax.....................................................................................................30
1.3.2.
Description of Azacitidine.....................................................................................................31
1.3.3.
Clinical Data for Venetoclax + Azacitidine ..........................................................................31
1.4.
Information About 7 + 3 Regimen ..........................................................................................................32
1.4.1.
Description of Cytarabine......................................................................................................32
1.4.2.
Description of Daunorubicin .................................................................................................32
1.4.3.
Description of Idarubicin.......................................................................................................33
1.4.4.
Clinical Data for 7 + 3 Regimen............................................................................................33
1.5.
Rationale for This Study..........................................................................................................................33
1.6.
Rationale for Dose Selection of Magrolimab..........................................................................................34
1.7.
Risk/Benefit Assessment for the Study ...................................................................................................35
1.8.
Compliance..............................................................................................................................................36
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................37
3.
STUDY DESIGN.................................................................................................................................................43
3.1.
Endpoints.................................................................................................................................................43
3.2.
Study Design ...........................................................................................................................................43
3.3.
Study Treatments.....................................................................................................................................44
3.4.
Duration of Treatment .............................................................................................................................45
3.5.
Discontinuation Criteria ..........................................................................................................................46
3.6.
End of Study............................................................................................................................................47
3.7.
Poststudy Care.........................................................................................................................................48
3.8.
Source Data .............................................................................................................................................48
3.9.
Biomarker Samples to Address the Study Objectives.............................................................................48
3.9.1.
..................................49
3.9.2.
TP53 Mutation Testing and Companion Diagnostic Development ......................................49
4.
PATIENT POPULATION ...................................................................................................................................51
4.1.
Number of Patients and Patient Selection ...............................................................................................51
4.1.1.
Patient Replacement ..............................................................................................................51
4.2.
Inclusion Criteria.....................................................................................................................................51
4.3.
Exclusion Criteria....................................................................................................................................52
5.
INVESTIGATIONAL MEDICINAL PRODUCTS.............................................................................................55
5.1.
Randomization, Blinding, and Treatment Codes Access ........................................................................55
5.1.1.
Randomization.......................................................................................................................55
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5.1.2.
Blinding .................................................................................................................................55
5.2.
Description and Handling of Magrolimab...............................................................................................55
5.2.1.
Formulation ...........................................................................................................................55
5.2.2.
Packaging and Labeling ........................................................................................................55
5.2.3.
Storage and Handling ............................................................................................................55
5.3.
Description and Handling of Azacitidine................................................................................................56
5.3.1.
Formulation ...........................................................................................................................56
5.3.2.
Packaging and Labeling ........................................................................................................56
5.3.3.
Storage and Handling ............................................................................................................56
5.4.
Description and Handling of Venetoclax ................................................................................................56
5.4.1.
Formulation ...........................................................................................................................56
5.4.2.
Packaging and Labeling ........................................................................................................56
5.4.3.
Storage and Handling ............................................................................................................56
5.5.
Description and Handling of Cytarabine.................................................................................................57
5.5.1.
Formulation ...........................................................................................................................57
5.5.2.
Packaging and Labeling ........................................................................................................57
5.5.3.
Storage and Handling ............................................................................................................57
5.6.
Description and Handling of Daunorubicin ............................................................................................57
5.6.1.
Formulation ...........................................................................................................................57
5.6.2.
Packaging and Labeling ........................................................................................................57
5.6.3.
Storage and Handling ............................................................................................................57
5.7.
Description and Handling of Idarubicin..................................................................................................57
5.7.1.
Formulation ...........................................................................................................................57
5.7.2.
Packaging and Labeling ........................................................................................................58
5.7.3.
Storage and Handling ............................................................................................................58
5.8.
Dosage and Administration .....................................................................................................................58
5.8.1.
Repriming/Reescalation for Magrolimab..............................................................................60
5.8.2.
7 + 3 Chemotherapy Administration.....................................................................................60
5.9.
Premedication and Prophylaxis ...............................................................................................................61
5.10.
Dose Modification and Delays ................................................................................................................62
5.10.1.
Magrolimab+Azacitidine (Experimental Arm).....................................................................62
5.10.2.
Venetoclax + Azacitidine (Control Arm for Patients Appropriate for 
Non-intensive Treatment)......................................................................................................69
5.10.3.
7 + 3 (or 5 + 2) Chemotherapy (Control Arm for Patients Appropriate for 
Intensive Treatment)..............................................................................................................69
5.11.
Prior and Concomitant Medications........................................................................................................70
5.11.1.
Permitted Concomitant Medications .....................................................................................70
5.11.2.
Prohibited Concomitant Medications....................................................................................70
5.11.3.
COVID-19 Vaccine...............................................................................................................71
5.12.
Accountability for Investigational Medicinal Product ............................................................................71
5.12.1.
Investigational Medicinal Product Return or Disposal .........................................................72
6.
STUDY PROCEDURES......................................................................................................................................73
6.1.
Patient Enrollment and Treatment Assignment.......................................................................................73
6.2.
Pretreatment Assessments .......................................................................................................................73
6.2.1.
Prescreening Visit..................................................................................................................73
6.2.2.
Screening Visit ......................................................................................................................73
6.3.
Randomization.........................................................................................................................................74
6.4.
On Study-Treatment Assessments...........................................................................................................75
6.4.1.
Pregnancy Test ......................................................................................................................75
6.4.2.
Complete Blood Counts ........................................................................................................75
6.4.3.
Peripheral Blood Smear Assessment.....................................................................................75
6.4.4.
Type and Screen and Direct Antiglobulin Test .....................................................................76
6.4.5.
Vital Signs .............................................................................................................................76


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6.4.6.
Physical Examination ............................................................................................................76
6.4.7.
Electrocardiograms................................................................................................................76
6.4.8.
Echocardiogram or MUGA ...................................................................................................76
6.4.9.
Bone Marrow Assessments ...................................................................................................77
6.4.10.
Patient-reported Outcomes ....................................................................................................79
6.4.11.
Adverse Events......................................................................................................................80
6.4.12.
Concomitant Medications......................................................................................................80
6.5.
Safety Assessments .................................................................................................................................80
6.6.
Efficacy Assessments ..............................................................................................................................82
6.7.
Pharmacokinetics.....................................................................................................................................83
6.8.
Immunogenicity (Antidrug Antibodies)..................................................................................................83
6.9.
Pharmacodynamics and Biomarker Assessments ...................................................................................84
6.9.1.
Correlative Blood Samples....................................................................................................84
6.9.2.
Minimal Residual Disease Monitoring..................................................................................84
6.9.3.
................................................................85
6.9.4.
Post-treatment Assessments ..................................................................................................86
6.10.
Assessments for Early Discontinuation from Study................................................................................86
6.10.1.
Criteria for Discontinuation of Study Treatment...................................................................86
6.11.
End of Study............................................................................................................................................86
6.12.
Poststudy Care.........................................................................................................................................86
6.13.
Sample Storage........................................................................................................................................87
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................88
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................88
7.1.1.
Adverse Events......................................................................................................................88
7.1.2.
Serious Adverse Events.........................................................................................................88
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .........................89
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................90
7.2.1.
Assessment of Causality for Study Drugs and Procedures ...................................................90
7.2.2.
Assessment of Severity..........................................................................................................91
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................91
7.3.1.
Requirements for Collection Prior to Study Drug Initiation .................................................91
7.3.2.
Adverse Events......................................................................................................................91
7.3.3.
Serious Adverse Events.........................................................................................................91
7.3.4.
Study Drug Special Situations Reports .................................................................................92
7.3.5.
Concomitant Therapy Reports...............................................................................................92
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports.......................................93
7.4.1.
Serious Adverse Event Reporting Process ............................................................................93
7.4.2.
Special Situations Reporting Process ....................................................................................93
7.5.
Gilead Reporting Requirements ..............................................................................................................95
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................95
7.7.
Abnormal Liver Function Tests...............................................................................................................96
7.8.
Toxicity Management..............................................................................................................................96
7.8.1.
Magrolimab ...........................................................................................................................96
7.8.2.
Venetoclax...........................................................................................................................101
7.8.3.
Azacitidine...........................................................................................................................101
7.8.4.
Cytarabine............................................................................................................................101
7.8.5.
Daunorubicin .......................................................................................................................101
7.8.6.
Idarubicin.............................................................................................................................101
8.
STATISTICAL CONSIDERATIONS...............................................................................................................102
8.1.
Analysis Objectives and Endpoints.......................................................................................................102
8.2.
Planned Analyses...................................................................................................................................102
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8.2.1.
Interim Analyses..................................................................................................................102
8.2.2.
Primary Analysis .................................................................................................................104
8.2.3.
Final Analysis......................................................................................................................104
8.3.
Analysis Conventions............................................................................................................................105
8.3.1.
Analysis Sets .......................................................................................................................105
8.3.2.
Data Handling Conventions ................................................................................................105
8.4.
Demographic and Baseline Characteristics Analysis............................................................................106
8.5.
Efficacy Analysis...................................................................................................................................106
8.5.1.
Primary Endpoint Analysis..................................................................................................106
8.5.2.
Secondary Efficacy Endpoints Analyses.............................................................................106
8.5.3.
...........................................................................................................107
8.5.4.
Analyses by Appropriateness for Intensive or Non-intensive Therapy...............................107
8.6.
Safety Analysis......................................................................................................................................107
8.6.1.
Extent of Exposure ..............................................................................................................107
8.6.2.
Adverse Events....................................................................................................................107
8.6.3.
Laboratory Evaluations .......................................................................................................108
8.6.4.
Other Safety Evaluations.....................................................................................................108
8.7.
Pharmacokinetic Analysis .....................................................................................................................108
8.8.
Analysis of Patient-Reported Outcome Data ........................................................................................109
8.9.
Immunogenicity Analysis......................................................................................................................109
8.10.
Biomarker Analysis...............................................................................................................................109
8.11.
Sample Size Rationale...........................................................................................................................109
8.12.
Data Monitoring Committee..................................................................................................................110
9.
RESPONSIBILITIES.........................................................................................................................................111
9.1.
Investigator Responsibilities .................................................................................................................111
9.1.1.
Good Clinical Practice.........................................................................................................111
9.1.2.
Financial Disclosure ............................................................................................................111
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................111
9.1.4.
Informed Consent ................................................................................................................111
9.1.5.
Confidentiality.....................................................................................................................112
9.1.6.
Study Files and Retention of Records .................................................................................112
9.1.7.
Case Report Forms ..............................................................................................................113
9.1.8.
Investigator Inspections.......................................................................................................114
9.1.9.
Protocol Compliance ...........................................................................................................114
9.2.
Sponsor Responsibilities .......................................................................................................................114
9.2.1.
Protocol Modifications ........................................................................................................114
9.2.2.
Study Reports and Publications...........................................................................................114
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................115
9.3.1.
Payment Reporting ..............................................................................................................115
9.3.2.
Access to Information for Monitoring.................................................................................115
9.3.3.
Access to Information for Auditing or Inspections .............................................................115
9.3.4.
Study Discontinuation .........................................................................................................115
10.
REFERENCES...................................................................................................................................................116
11.
APPENDICES....................................................................................................................................................122
Appendix 1.
Investigator Signature Page...................................................................................................123
Appendix 2.
Schedules of Assessment.......................................................................................................124
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan ..................................................................145
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................150
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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................151
Appendix 6.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria........................................................................155
Appendix 7.
European Organisation for the Research and Treatment of Cancer Quality of Life 
Questionnaire–Core Questionnaire (EORTC QLQ-C30)......................................................159
Appendix 8.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L).................................................161
Appendix 9.
Patient Global Impression of Severity (PGIS) and Patient Global Impression of 
Change (PGIC) ......................................................................................................................164
Appendix 10.
Eastern Cooperative Oncology Group Performance Status...................................................166
Appendix 11.
Cockcroft-Gault Method for Estimating Creatinine Clearance .............................................167
Appendix 12.
World Health Organization (WHO) Classification of AML.................................................168
Appendix 13.
Amendment History ..............................................................................................................169
LIST OF IN-TEXT TABLES
Table 1
Study Objectives and Endpoints..............................................................................................37
Table 2.
Dosing and Schedule for Magrolimab and Azacitidine Experimental Arm............................44
Table 3.
Dosing and Schedule for Venetoclax and Azacitidine Control Arm.......................................45
Table 4.
Dosing and Schedule for 7 + 3 Chemotherapy Control Arm ..................................................45
Table 5.
7 + 3 Regimen Description......................................................................................................61
Table 6.
Repriming Guidelines for Magrolimab ...................................................................................63
Table 7.
Magrolimab Dosing Guidance for Planned Surgical Procedures on Study.............................63
Table 8.
Azacitidine Dose Modification for Patients With and Without Cytopenia at Baseline ..........65
Table 9.
Azacitidine Dose Modification: Patients With Reduced Bone Marrow Cellularity 
and Reduced Peripheral Blood Counts....................................................................................67
Table 10.
Azacitidine Dose Modification: Nonhematologic Toxicities..................................................68
Table 11.
Dose Modifications and Delays for Venetoclax Due to Adverse Events................................69
Table 12.
Management of Potential Venetoclax Interactions with CYP3A and P-gp Inhibitors............71
Table 13.
Timing of Response Assessments ...........................................................................................77
Table 14.
Laboratory Analyte Listing (to be Performed at Screening) ...................................................81
Table 15.
Laboratory Analyte Listing (to be Performed During the Study)............................................82
Table 16.
Management of Infusion-related Reactions.............................................................................98
Table 17.
Pneumonitis Management Algorithm....................................................................................100
Table 18.
Stopping Boundaries for Efficacy Analyses for Superiority.................................................103
Table 19.
Definition of Information Fraction........................................................................................103
Table 20.
Schedule of Assessments – Screeninga..................................................................................124
Table 21.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) 
and Venetoclax + Azacitidine Regimens...............................................................................126
Table 22.
Magrolimab Administration and Associated Assessment Schedule-Treatment Period ........130
Table 23.
Schedule of Assessments - Treatment Period for the 7 + 3 Regimen ...................................131
Table 24.
Schedule of Assessments – Post treatment............................................................................134
Table 25.
Schedule of Assessments - Repriming/Reescalation Cycle (Required after 
Magrolimab Delays of > 4 Weeks)........................................................................................136
Table 26.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) 
and Venetoclax + Azacitidine Regimens, in the Event the Study Meets Futility, and 
the Sponsor Decides to Terminate the Study.........................................................................138
Table 27.
Magrolimab Administration and Associated Assessment Schedule-Treatment 
Period, in the Event the Study Meets Futility, and the Sponsor Decides to Terminate 
the Study................................................................................................................................141
Table 28.
Schedule of Assessments – Posttreatment, in the Event the Study Meets Futility, and 
the Sponsor Decides to Terminate the Study.........................................................................142


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Table 29.
Schedule of Assessments - Repriming/Re-escalation Cycle (Required after 
Magrolimab Delays of > 4 Weeks), in the Event the Study Meets Futility, and the 
Sponsor Decides to Terminate the Study ..............................................................................143
Table 30.
Response Criteria in Acute Myeloid Leukemia (ELN 2017 Recommendations with 
Modifications) .......................................................................................................................156
Table 31.
Additional Response Definitions Used in This Study (2003 IWG Criteria) .........................157
Table 32.
Response Criteria for Hematologic Improvement.................................................................158
LIST OF IN-TEXT FIGURES
Figure 1.
Study Schema ..........................................................................................................................44


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title:
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and 
Efficacy of Magrolimab in Combination with Azacitidine versus 
Physician’s Choice of Venetoclax in Combination with Azacitidine or 
Intensive Chemotherapy in Previously Untreated Patients with TP53 
Mutant Acute Myeloid Leukemia
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
147229
2020-003949-11
NCT04778397
Study Centers 
Planned:
Approximately 170 centers
Objectives:
The primary objective of this study is as follows:
•
To compare the efficacy of magrolimab + azacitidine versus 
venetoclax + azacitidine in patients with previously untreated TP53 
mutant acute myeloid leukemia (AML) who are appropriate for 
non-intensive therapy as measured by overall survival (OS).
The secondary objectives of this study are as follows:
•
To compare the efficacy of magrolimab + azacitidine versus 
physician’s choice of venetoclax + azacitidine or 7 + 3 
chemotherapy in all patients with previously untreated TP53 mutant 
AML as measured by OS.
•
To compare the efficacy of magrolimab + azacitidine versus 
physician’s choice of venetoclax + azacitidine or 7 + 3 
chemotherapy in all patients as measured by event-free survival 
(EFS).
•
To compare the efficacy of magrolimab + azacitidine versus 
physician’s choice of venetoclax + azacitidine or 7 + 3 
chemotherapy as measured by rate of complete remission (CR) 
within 2 months of treatment for patients treated with 7 + 3 
chemotherapy and within 6 months of treatment for other patients.


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• 
To compare the efficacy of magrolimab + azacitidine versus 
physician's choice of venetoclax + azacitidine or 7 + 3 
chemotherapy as measured by rate of CR without minimal residual 
disease (CRMRD-) within 2 months of treatment for patients treated 
with 7 + 3 chemotherapy and within 6 months of treatment for 
other patients. 
• 
To compare the efficacy of magrolimab + azacitidine versus 
physician's choice of venetoclax + azacitidine or 7 + 3 
chemotherapy in all patients as measured by the rate of 
CR + complete remission with paiiial hematologic recove1y (CRh) 
within 2 months of treatment for patients treated with 7 + 3 
chemotherapy and within 6 months of treatment for other patients. 
• 
To evaluate the duration of complete remission (DCR) in patients 
who achieved CR within 6 months of treatment with magrolimab + 
azacitidine or venetoclax + azacitidine, or within 2 months of 7 + 3 
chemotherapy. 
• 
To evaluate the duration of CR + CRh in patients who achieved CR 
or CRh within 6 months of treatment with magrolimab + 
azacitidine or venetoclax + azacitidine, or within 2 months of 7 + 3 
chemotherapy. 
• 
To assess the safety and tolerability of magrolimab + azacitidine 
versus physician's choice of venetoclax + azacitidine or 7 + 3 
chemotherapy. 
• 
To evaluate the phannacokinetics (PK) and immunogenicity of 
magrolimab. 
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This is a Phase 3, randomized, open-label, multicenter study comparing 
magrolimab + azacitidine versus venetoclax + azacitidine or 7 + 3 
chemotherapy in patients with previously untreated TP53 mutant AML. 
Approximately 346 patients will be randomized in 1 : 1 ratio to receive 
either magrolimab + azacitidine (experimental aim) or physician's 
choice of venetoclax + azacitidine or 7 + 3 chemotherapy ( control 
ann). Randomization will be stratified by 3 factors: 
• 
appropriateness for non-intensive therapy versus intensive therapy 
• 
age ( < 7 5 yeai·s, 7 5 yeai·s) 
• 
geographic region (United States [US], outside the US) 
Study Des,gn 
Tnal Population 
=
/ 1'·-
COntrol 
'l'enetodex + azac1tld1ne 
Expenmertal 
magrobmab + azaotdine 
ofatltaSl1 
Physician·•{ 
TP53 m.italion choice 
thatisnot~nign 
\ 
•. •• • ·, , 
1:1 R8'1doftlaation 
or likely benigl 
, 
Stratification: 
1) Appropria:enMsfor non-intensive therapy v, intenSNe lherapy 
2) Age (<75vn75) 
3) Geographic reg,on: (US vs. outside lhe US) 
The primaiy endpoint is OS in the stratum of patients appropriate for 
non-intensive therapy. The primaiy analysis of OS will be conducted 
when 171 deaths have occmTed in the stratum of patients appropriate 
for non-intensive therapy. An interim futility analysis and an interim 
superiority analysis will be conducted separately after approximately 
69 and 128 deaths (40% and 75% of the expected 171 deaths, 
respectively) in the stratum of patients appropriate for non-intensive 
therapy have occmTed. In the event the study meets futility, the sponsor 
may decide to te1minate the study, and recommend patients receiving 
treatment transition to standai·d of care (SOC) therapy. The cmTent 
study met futility and sites were info1med of the outcome and 
sponsor's decision in a communication in September 2023. 
Page 11 
02 November 2023 


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If an investigator believes that continued treatment with 
magrolimab + azacitidine is in the best interest of their patient(s), 
Gilead will continue to provide study drug, with a reduced schedule of 
assessments, pending final study closure; if an investigator believes 
that continued treatment with venetoclax + azacitidine is in the best 
interest of their patient(s), and the combination is not available locally 
as SOC, Gilead may continue to provide drug, pending final study 
closure.
Number of 
Patients Planned:
A minimum of 228 patients appropriate for non-intensive therapy. 
Approximately 346 patients in total.
Target 
Population:
Patients with untreated TP53 mutant AML who are ≥ 18 years of age
Duration of 
Treatment:
Cycle length is 28 days for patients in the experimental arm and in the 
control arm venetoclax + azacitidine and all patients will continue on 
study treatment unless they meet study treatment discontinuation 
criteria. For 7 + 3 chemotherapy, cycle length is up to 42 days, and 
patients will stop treatment after 4 cycles of consolidation treatment.
Diagnosis and 
Eligibility 
Criteria:
Inclusion Criteria:
1) Patients with confirmation of AML by World Health Organization 
criteria, previously untreated for AML, and who have presence of: 
a) At least 1 TP53 gene mutation that is not benign or likely 
benign based on evaluation by either central laboratory or an 
approved local laboratory (after central review of the bone 
marrow TP53 mutation next-generation sequencing test results)
b) Biallelic 17p deletions, loss of both 17p alleles, based on locally 
evaluated cytogenetics/karyotype/fluorescence in situ 
hybridization (FISH) report.
2) Patients with white blood cell (WBC) count ≤ 20  103/µL prior to 
randomization. If the patient’s WBC is > 20 × 103/µL prior to 
randomization, the patient can be enrolled, assuming all other 
eligibility criteria are met. However, the WBC should 
be ≤ 20  103/µL prior to the first dose of study treatment and prior 
to each magrolimab dose for the first 4 weeks (if the patient is 
randomized to the experimental arm).
NOTE: patients can be treated with hydroxyurea and/or 
leukapheresis throughout the study or prior to randomization to 
reduce the WBC to ≤ 20  103/µL to enable eligibility for study 
drug dosing. 


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3) The hemoglobin must be ≥ 9 g/dL prior to initial dose of study 
treatment 
NOTE: Transfusions are allowed to meet hemoglobin eligibility.
4) Patient has provided informed consent.
5) Patient is willing and able to comply with clinic visits and 
procedure outlined in the study protocol.
6) Male or female, ≥ 18 years of age.
7) Patients must have an Eastern Cooperative Oncology Group 
(ECOG) performance status of 0 to 2, except for patients less than 
75 years of age and appropriate for non-intensive treatment. For 
these patients, the ECOG performance status score may be 0 to 3.
8) Patients must have adequate renal function as demonstrated by a 
creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft 
Gault formula.
9) Adequate cardiac function as demonstrated by:
a) Lack of symptomatic congestive heart failure and clinically 
significant cardiac arrhythmias and ischemic heart disease.
b) Left ventricular ejection fraction (LVEF) > 50% for patients 
appropriate for intensive therapy.
10) Adequate liver function as demonstrated by:
a) Aspartate aminotransferase ≤ 3.0  upper limit of normal 
(ULN)
b) Alanine aminotransferase ≤ 3.0  ULN
c) Total bilirubin ≤ 1.5  ULN, or primary unconjugated bilirubin 
≤ 3.0  ULN if patient has a documented history of Gilbert’s 
syndrome or genetic equivalent.
11) Pretreatment blood cross-match completed.
12) Male and female patients of childbearing potential who engage in 
heterosexual intercourse must agree to use protocol-specified 
method(s) of contraception.
13) Patients must be willing to consent to mandatory pretreatment and 
on-treatment bone marrow biopsies (aspirate and trephines).


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Exclusion Criteria:
1) Subjects that are unable to give consent. To give consent, the 
individual concerned must be of legal age and be able to understand 
the nature, significance and implications of the clinical study and 
form their rational intentions in light of these.
2) Positive serum pregnancy test
3) Breastfeeding female
4) Known hypersensitivity to any of the study drugs, the metabolites, 
or formulation excipient
5) Prior treatment with any of the following:
a) CD47 or signal regulatory protein alpha (SIRPα)-targeting 
agents
b) Antileukemic therapy for the treatment of AML (eg, 
hypomethylating agent [HMA], low dose cytarabine and/or 
venetoclax), excluding hydroxyurea. 
NOTE: Patients with prior myelodysplastic syndrome (MDS) 
who have not received prior HMAs or chemotherapeutic agents 
for MDS are allowed on study. Other prior MDS therapies 
including, but not limited to, lenalidomide, erythroid 
stimulating agents, or similar red blood cell (RBC)-direct 
therapies, are allowed. Localized non-central nervous system 
(CNS) radiotherapy, erythroid and/or myeloid growth factors, 
hormonal therapy with luteinizing hormone-releasing hormone 
agonists for prostate cancer, hormonal therapy or maintenance 
for breast cancer, and treatment with bisphosphonates and 
receptor activator of nuclear factor kappa-B ligand inhibitors 
are also not criteria for exclusion.
c) Patients who are appropriate for intensive treatment but who 
have been previously treated with maximum cumulative doses 
of idarubicin and/or other anthracyclines and anthracenediones 
will be excluded.
6) Patients receiving any live vaccine within 4 weeks prior to 
initiation of study treatments.
7) For patients appropriate for intensive therapy, patients treated with 
trastuzumab within 7 months prior to initiation of study treatments.
8) Current participation in another interventional clinical study.
9) Known inherited or acquired bleeding disorders.
10) Patients appropriate for non-intensive therapy, who have received 
treatment with strong and/or moderate cytochrome P450 enzyme 
(CYP)3A inducers within 7 days prior to the initiation of study 
treatments.


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11) Patients appropriate for non-intensive therapy who have consumed 
grapefruit, grapefruit products, Seville oranges (including 
marmalade containing Seville oranges), or starfruit within 3 days 
prior to the initiation of study treatment.
12) Patients appropriate for non-intensive therapy who have 
malabsorption syndrome or other conditions that preclude enteral 
route of administration.
13) Clinical suspicion of active CNS involvement with AML.
14) Patients who have acute promyelocytic leukemia.
15) Significant disease or medical conditions, as assessed by the 
investigator and sponsor, that would substantially increase the 
risk-benefit ratio of participating in the study. This includes, but is 
not limited to, acute myocardial infarction within the last 6 months, 
unstable angina, uncontrolled diabetes mellitus, significant active 
infections, and congestive heart failure New York Heart 
Association Class III-IV.
16) Second malignancy, except MDS, treated basal cell or localized 
squamous skin carcinomas, localized prostate cancer, or other 
malignancies for which patients are not on active anti-cancer 
therapies and have had no evidence of active malignancy for at 
least ≥ 1 year.
NOTE: patients on maintenance therapy alone who have no 
evidence of active malignancy for at least ≥ 1 year are eligible.
17) Known active or chronic hepatitis B virus (HBV) or hepatitis C 
virus (HCV) infection or HIV infection in medical history.
18) Active HBV, and/or active HCV, and/or HIV following testing at 
screening:
a) Patients who test positive for hepatitis B surface antigen 
(HBsAg). Patients who test positive for hepatitis B core 
antibody (anti-HBc) will require HBV DNA by quantitative 
polymerase chain reaction (PCR) for confirmation of active 
disease.
b) Patients who test positive for HCV antibody. These patients 
will require HCV RNA quantitative PCR for confirmation of 
active disease.
c) Patients who test positive for HIV antibody. 
d) Patients not currently receiving antiviral therapy and who have 
an undetectable viral load in the prior 3 months may be eligible 
for the study.


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Gilead Sciences, Inc.
Amendment 5
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Study 
Procedures/
Frequency:
Following completion of screening and admission assessments, eligible 
patients will be randomized 1:1 to receive either 
magrolimab + azacitidine (experimental arm) or physician’s choice of 
venetoclax + azacitidine or 7 + 3 chemotherapy (control arm).
The study treatments within each arm are as follows:
Dosing and Schedule for Magrolimab and Azacitidine 
Experimental Arm
Dose Schedule (Day per 28-day Cycle)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Azacitidine 75 mg/m2 SC or 
IVa
Days 1–7
or
Days 1–5 and 
8, 9b
Days 1–7
or
Days 1–5 and 
8, 9b
Days 1–7
or
Days 1–5 and 
8, 9b
Magrolimab Administration
Magrolimab 1 mg/kg IV 
(over 3 hours)
Days 1, 4
Magrolimab 15 mg/kg IV 
(over 3 hours)
Day 8
Magrolimab 30 mg/kg IV 
(over 2 hours)
Days 11 and 15, and then QW x 5 weekly 
30 mg/kg dose 
Magrolimab 30 mg/kg IV 
(over 2 hours)
Q2W beginning 1 week after the 5 weekly 
30 mg/kg dose
IV = intravenous; PO = orally; Q2W = every 2 weeks; QW = once a week; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days.
Dosing and Schedule for Venetoclax and Azacitidine Control Arm
Dose Schedule (Day per 28-day Cycle)
Control Arm
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Venetoclax 
100 mg oral
Day 1
—
—
Venetoclax 
200 mg oral
Day 2
—
—
Venetoclax 
400 mg oral
Day 3 and 
daily 
thereafter
Daily
Daily
Venetoclax + 
Azacitidine
Azacitidine 
75 mg/m2 SC or 
IVa
Days 1–7
or
Days 1–5 
and 8–9b
Days 1–7
or
Days 1–5 
and 8–9b
Days 1–7
or
Days 1–5 
and 8–9b
IV = intravenous; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days.


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Gilead Sciences, Inc.
Amendment 5
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Dosing and Schedule for 7 + 3 Chemotherapy Control Arm
Control Arm 
(7 + 3)
Drug/Dose/Route
7 + 3 
Induction
5 + 2 Induction, if needed 
(after C1D15 bone 
marrow assessment)
Daunorubicin 
60 mg/m2 IVP
or 
Idarubicin 
12 mg/m2 IV
Days 1–3
Days 1-2
Induction
Cytarabine 
100 or 200 mg/m2 
CI
Days 1–7
Days 1–5
Cytarabine 
(HiDAC) 1500 or 
3000 mg/m2 IVa
Every 12 hours on Days 1, 3, and 5
(up to 4 cycles)
Consolidation
Steroidal Eye 
Drops
As per institutional standard
C1D15 = Cycle 1 Day 15; CI = continuous infusion; HiDAC = high-dose cytarabine; IV = 
intravenous; IVP = intravenous peripheral
a
In some cases, patients ≥ 60 years of age can receive 1000 mg/m2 based on local practice.
For the experimental arm and the control arm venetoclax + azacitidine, 
cycle lengths are 28 days and all patients will continue on study 
treatment until disease progression, relapse, loss of clinical benefit, or 
unacceptable toxicities occur.
Treatment with azacitidine as SOC is recommended for a minimum of 
6 cycles. Therefore, in this study, for the patients in the magrolimab + 
azacitidine or venetoclax + azacitidine treatment arms, those without 
evidence of disease progression (including relapse after 
partial/complete remission [PR/CR]), loss of clinical benefit, or 
unacceptable toxicity should continue study treatment. For those in the 
7 + 3 chemotherapy treatment arm, treatment should continue until the 
end of the induction cycle(s). Acute myeloid leukemia disease response 
assessment will be performed at the end of Cycle 1, Cycle 2, Cycle 4, 
Cycle 6 and every 3 cycles thereafter during the study treatment period 
for the magrolimab + azacitidine and venetoclax + azacitidine 
treatment arms. For the 7 + 3 control arm, response assessments will be 
performed:
•
on Cycle 1 Day 15 (after 7 + 3 only; to determine if a new 
induction of 5 + 2 is needed); and 
•
at count recovery or Day 42 after the start of the most recent 
induction treatment, whichever is earlier; and 


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•
if therapy is stopped at:
Consolidation Cycle 1, then at count recovery after 
consolidation Cycle 1 or Day 42 after the start of Consolidation 
Cycle 1, whichever is earlier, or
Consolidation Cycle 2, then at count recovery after 
Consolidation Cycle 2 or Day 42 after the start of Consolidation 
Cycle 2, whichever is earlier, or
Consolidation Cycle 3, then at count recovery after 
Consolidation Cycle 2 and Cycle 3, or Day 42 after the start of 
each Consolidation Cycle 2 and Consolidation Cycle 3, 
whichever is earliest, or
Consolidation Cycle 4, then at count recovery after 
Consolidation Cycle 2 and Cycle 4, or Day 42 after the start of 
each Consolidation Cycle 2 and Consolidation Cycle 4, 
whichever is earliest; and
•
every 12 weeks thereafter.
Patients will continue follow-up study visits unless they withdraw 
completely from the study.
In case patients discontinue the study treatment due to reasons other 
than disease progression or relapse, patients will be followed for 
response assessments until documented disease progression or relapse 
or initiation of new anti-AML therapy (excluding SCT and 
maintenance). For patients who discontinue the study treatment to 
receive a stem cell transplant, follow-up for response assessment and 
collection of bone marrow biopsy/aspirate results will continue every 
12 weeks from the date of SCT, until documented disease progression 
or relapse or initiation of new anti-AML therapy (excluding 
maintenance therapy) occurs. Then patients will be observed for 
survival until death, withdrawal of consent, lost to follow-up, or the 
end of the study, whichever occurs first.
Treatment with magrolimab or venetoclax as single agent is not 
permitted. Patients who discontinue magrolimab + azacitidine, or 
venetoclax + azacitidine, but continue in a response or are achieving 
clinical benefit will continue to be followed on study for response 
assessments to ascertain relapse and for long-term survival.
All patients will be followed for survival until death. For any patient 
who dies during this follow-up period, the immediate cause of death 
must be reported to the sponsor.


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Gilead Sciences, Inc.
Amendment 5
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In the event the study meets futility, and the sponsor decides to 
terminate the study, all patients who discontinue study treatment for 
any reason will not be followed for response or survival.
Test Product, Dose, 
and Mode of 
Administration:
Magrolimab 1 mg/kg intravenous (IV)
Magrolimab 15 mg/kg IV
Magrolimab 30 mg/kg IV
In combination with:
Azacitidine 75 mg/m2 IV or SC
Reference Therapy, 
Dose, and Mode of 
Administration:
Venetoclax 10 mg oral
Venetoclax 50 mg oral
Venetoclax 100 mg oral
In combination with:
Azacitidine 75 mg/m2 IV or SC
Or
Cytarabine 100 or 200 mg/m2 CI in combination with Daunorubicin 
60 mg/m2 IVP or Idarubicin 12 mg/m2 IV followed by
Cytarabine (HiDAC) 1000 or 1500 or 3000 mg/m2 IV
Criteria for 
Evaluation:
Safety:
Safety will be evaluated by data including the incidence of adverse 
events (AEs) for the duration of the study, assessment of clinical 
laboratory test findings, physical examination, 12-lead 
electrocardiogram, ECOG performance status, and vital signs 
measurements. Adverse events will be graded using National Cancer 
Institute Common Terminology Criteria for Adverse Events 
(NCI CTCAE) v5.0. 
Efficacy:
Efficacy will be evaluated by OS, EFS, transfusion independence rate, 
CR rate, CRMRD- rate, GHS/QoL and physical functioning scale scores 
from EORTC QLQ-C30, CR + CRh rate, ORR, DCR, duration of 
CR + CRh, and DOR. Assessment of leukemia response in AML 
patients will be conducted using the European LeukemiaNet (ELN) 
2017 recommendations for AML and the 2003 International Working 
Group (IWG) criteria with modifications.


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Gilead Sciences, Inc.
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Pharmacokinetics:
Magrolimab serum drug concentrations will be assessed in the 
magrolimab + azacitidine group at predose and at regular intervals 
postdose until study discontinuation. Samples will also be collected for 
the detection of antidrug antibodies (ADA) against magrolimab. 
Presence of neutralizing antibodies to magrolimab will also be assessed 
in the ADA positive samples.
Statistical 
Methods:
Analysis Data Set
The Intent-to-Treat (ITT) Analysis Set includes all randomized patients 
according to the treatment arm to which the patient is randomized, 
unless otherwise specified. This is the primary analysis set for efficacy 
analysis.
The Safety Analysis Set will include all patients who received at least 
1 dose of any study treatment, with treatment assignments designated 
according to the actual treatment received.
The PK Analysis Set will include all randomized patients who received 
at least 1 dose of magrolimab and have at least 1 measurable 
posttreatment serum concentration of magrolimab.
The Immunogenicity Analysis Set will include all randomized patients 
who received at least 1 dose of magrolimab and had at least 1 evaluable 
anti-magrolimab antibody test result.
The Biomarker Analysis Set includes all randomized patients who 
received at least 1 dose of any study drug and have at least 1 evaluable 
biomarker measurement available. This will be the primary analysis set 
for all biomarker data analyses.
Efficacy Analysis
Time-to-event endpoints, including OS, EFS, and DCR, will be 
summarized using Kaplan-Meier estimates, which include median and 
the proportion of event-free patients at benchmark time points such as 
6 months and 12 months. The Kaplan-Meier plots will be provided.
Hypothesis testing will be performed on the ITT Analysis Set for OS 
and EFS using the log-rank test stratified by randomization 
stratification factors. The hazard ratio (HR) with the corresponding 
2-sided 95% CIs estimated using a Cox proportional hazard regression 
model stratified by randomization stratification factors will also be 
presented for OS and EFS.
Categorical endpoints including CR rate, CRMRD− rate, CR + CRh rate, 
and transfusion independence conversion rate will be compared 
between arms using Cochran-Mantel-Haenszel test stratified by 
randomization stratification factors. The point estimate of these rates 
and the corresponding 2-sided exact 95% CIs based on the exact 
Clopper-Pearson method will be provided for each treatment arm.


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Amendment 5
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The TTD on the EORTC QLQ-C30 GHS/QoL scale, defined as the 
time from date of randomization to the first time a patient experienced 
at least 1 threshold value deterioration from baseline or death, and TTD 
on the EORTC QLQ-C30 physical functioning scale may be 
summarized using the Kaplan-Meier method. The log-rank test 
stratified by randomization stratification factors will be conducted for 
comparison between treatment arms, and the HR estimated using a Cox 
proportional hazard regression model stratified by randomization 
stratification factors will be provided.
To strongly control the overall type I error across the testing of primary 
and key secondary endpoints, a hierarchical testing strategy will be 
performed with a predefined order as listed in the protocol and the 
statistical analysis plan. A given hypothesis can only be tested and 
declared statistically significant if all previous hypotheses in the 
hierarchy are also statistically significant. The overall study-wide type I 
error is 1-sided 0.025. To protect the integrity of the study, an 
administrative 1-sided type I error of 0.0001 will be spent for the 
interim futility analysis. As a result, a 1-sided type I error of 0.0249 
will be left for the superiority analysis of the primary and key 
secondary efficacy endpoints using the hierarchical testing approach.
Safety Analysis
Safety will be assessed via AEs, clinical laboratory tests, and 
concomitant medications in the Safety Analysis Set by treatment arm. 
Information regarding study drug administration, study drug 
compliance, and other safety variables will also be summarized.
Interim Analysis
An interim futility analysis and an interim superiority analysis of OS 
will be performed separately when approximately 69 deaths and 
128 deaths (40% and 75% of the expected 171 deaths, respectively) in 
the stratum of patients appropriate for non-intensive therapy have 
occurred.
Primary Analysis
If the null hypothesis on the primary endpoint of OS is not rejected in 
the interim efficacy analysis, the primary analysis of OS will be 
performed separately when approximately 171 deaths have occurred in 
the stratum of patients appropriate for non-intensive therapy.
In the event the study meets futility, and the sponsor decides to 
terminate the study, the planned interim superiority analysis and 
primary analysis will no longer be required.


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Sample Size
It is assumed that administration of magrolimab + azacitidine to study 
patients will result in a median OS of approximately 9.77 months, 
improved from a median OS of 6.35 months in patients treated with 
venetoclax + azacitidine or 7 + 3 chemotherapy. This corresponds to an 
OS HR of 0.65. The median OS assumptions are based on the 
observations from Study 5F9005, which enrolled TP53 mutant AML 
patients treated with magrolimab + azacitidine and the publication of 
studies for venetoclax in combination with hypomethylating agents in 
TP53 mutant AML patients.
It is assumed that the duration of OS is exponentially distributed in 
each of the 2 arms. With an HR equal to 1 under the null hypothesis of 
no difference between the 2 treatment arms, an HR of 0.65 under the 
alternative hypothesis of superiority of the magrolimab + azacitidine, a 
planned interim futility analysis when 40% OS events are observed, 
and an interim superiority analysis when 75% OS events are observed, 
171 events (deaths) are required to achieve a power of 79.7% based on 
a log-rank test with an overall 1-sided significance level of 0.025 in the 
stratum of patients appropriate for non-intensive therapy; 
approximately 234 deaths may be observed in all patients when 
171 events occur in the stratum of patients appropriate for non-
intensive therapy. That provides a power of 90.4% for the OS test in all 
patients based on the log-rank test.
The study will enroll a minimum of 228 patients appropriate for 
non-intensive therapy to ensure adequate events (171 deaths) for the 
primary endpoint analysis. The study enrollment may stop after 
228 patients in the non-intensive therapy group or approximately 
346 of all patients are enrolled, whichever occurs later. The study 
duration and the total number of patients to be enrolled will depend on 
the prevalence of patients appropriate for non-intensive therapy in the 
overall population. When the enrollment of the required number of all 
patients finishes later than that of patients in the non-intensive therapy 
group, assuming a planned accrual period of 23 months, a study 
duration of 27 months, and an expectation that 10% of patients are 
likely to drop out by the end of study (annual dropout rate 4.8% 
assuming time to drop-out is exponentially distributed), approximately 
173 patients in the experimental arm and 173 patients in the control 
arm (approximately 346 total) are to be enrolled. In the event the study 
meets futility, and the sponsor decides to terminate the study, no 
further patients will be enrolled. 
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
ABO
any of the 4 blood groups A, B, AB, and O comprising the ABO system
ADA
antidrug antibody
AE
adverse event
ALT
alanine aminotransferase
AML
acute myeloid leukemia
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
ASCO
American Society of Clinical Oncology
AST
aspartate aminotransferase
CBC
complete blood count
Ccr
cytogenetic complete remission
CI
confidence interval
CLIA
Clinical Laboratory Improvement Amendments
CLL
chronic lymphocytic leukemia
CMV
cytomegalovirus
CNS
central nervous system
CR
complete remission
CRF
case report form
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete count recovery
CRMRD−
complete remission without minimal residual disease
CRMRD+/unk
complete remission with positive or unknown minimal residual disease
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CYP
cytochrome P450 enzyme
DAT
direct antiglobulin test
DCR
duration of complete remission
DMC
data monitoring committee
DNA
deoxyribonucleic acid
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EDC
electronic data capture
EFS
event-free survival
ELISA
enzyme-linked immunosorbent assay
ELN
European LeukemiaNet
EQ-5D-5L
5-level EuroQol 5 dimensions


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EQ VAS
EQ visual analogue scale
EOT
end of treatment
EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core Questionnaire
EU 
European Union
FDA
Food and Drug Administration
FISH
fluorescence in situ hybridization
FSH
follicle-stimulating hormone
GHS/QoL
global health status/quality of life
GCP
Good Clinical Practice
HBV
hepatitis B virus
HCV
hepatitis C virus
HiDAC
high-dose cytarabine
HMA
hypomethylating agent
HR
hazard ratio
HRQoL
health-related quality of life
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
IEC
independent ethics committee
IgG4
immunoglobulin G4
INR
international normalized ratio
IND
investigational new drug
IPSS-R
Revised International Prognostic Scoring System
IRB
institutional review board
IRR
infusion-related reaction
ITT
Intent-to-Treat
IV
intravenous
IVP
intravenous peripheral
IWG
International Working Group
LHRH
luteinizing hormone-releasing hormone
LVEF
left ventricular ejection fraction
mAb
monoclonal antibody
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MLFS
morphologic leukemia-free state
MNS
a human blood group system based upon 2 genes (glycophorin A and glycophorin B) on 
chromosome 4
MOA
mechanism of action
MRD
minimal residual disease


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MTD
maximum tolerated dose
MUGA
multigated acquisition (scan)
NCI CTCAE
National Cancer Institute Common Terminology Criteria for Adverse Events
NGS
next-generation sequencing
NHL
non-Hodgkin lymphoma
ORR
objective response rate
OS
overall survival
PCR
polymerase chain reaction
PD
progressive disease
PGIC
Patient Global Impression of Change
PGIS
Patient Global Impression of Severity
PK
pharmacokinetic(s)
PR 
partial remission
PR/CR
partial/complete remission
PRO
patient-reported outcome
PT
prothrombin time
GLPS
Patient Safety 
Q2W
every 2 weeks
RANKL
receptor activator of nuclear factor kappa-B ligand
RBC
red blood cell
Rh
rhesus factor 
RNA
ribonucleic acid
RO 
receptor occupancy
SAE
serious adverse event
SAP
statistical analysis plan
SC
subcutaneous
SCT
stem cell transplant
SIRPα
signal regulatory protein alpha
SOC
standard of care
SOP
standard operating procedure
SSR
special situation reports
SUSAR
suspected unexpected serious adverse reaction
TTD
time to first deterioration
ULN
upper limit of normal
US
United States
WBC
white blood cell


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1.
INTRODUCTION
1.1.
Background
Acute myeloid leukemia (AML) is a common hematologic malignancy whose incidence rises 
from 3:100,000 in young adults to greater than 20:100,000 in older adults. For 
patients < 60 years of age, 5-year overall survival (OS) is 40% to 50% but is only 5% for 
patients > 60 years of age. The majority of newly diagnosed previously untreated patients with 
AML are above the age of 60 years. In this patient population, standard intensive induction 
chemotherapy is often not an option due to increased treatment-related mortality as a result of 
age and co-morbidities. Standard of care (SOC) for AML patients unfit for combination 
chemotherapy is treatment with hypomethylating agents (HMAs) (azacitidine or decitabine) or 
low dose cytarabine. Venetoclax in combinations with either azacitidine, decitabine, or low dose 
cytarabine is also used as SOC in several regions. Despite these frontline treatments, median OS 
is only about 10 to 15 months. In all types of AML, disease relapse is common despite an initial 
therapeutic response and is the most common reason for death. Standard chemotherapy and stem 
cell transplant (SCT) (when used) often fail to eradicate all tumor-propagating cells and select 
for chemotherapy-resistant leukemia propagating subclones. Patients refractory to salvage 
therapy are treated palliatively, as current treatment options are extremely limited. These patients 
have a median survival of 2 months.
Acute myeloid leukemia patients harboring a TP53 mutation comprise approximately 10% to 
15% of all AML patients {Kadia 2016, Rucker 2012}. TP53 mutant AML patients represent an 
extremely poor prognostic group that is highly refractory to standard therapies that include both 
intensive and non-intensive therapies. The median OS of TP53 mutant patients is approximately 
4 months, compared to 11 months for their wildtype counterparts {Rucker 2012}. In previously 
untreated AML patients who are unfit for intensive chemotherapy, TP53 mutations predict a 
worse prognosis compared to all-comers with standard azacitidine therapy {Bally 2014}. In 
untreated TP53 mutant unfit AML, azacitidine has demonstrated objective responses from 20% 
to 40% with a median OS of approximately 7 months {Dohner 2018, Sallman 2018}.
Despite recently approved therapies in AML, treatment for patients with TP53 mutant AML remains 
a high unmet medical need. In 2018, venetoclax in combination with HMAs or low dose cytarabine 
was granted accelerated approval in the United States (US) for AML patients who are ineligible 
for intensive induction chemotherapy. While meaningful clinical benefit is observed in these 
AML patients, a subset of these patients, specifically those harboring a TP53 mutation, have 
limited benefit. For Food and Drug Administration (FDA) approved venetoclax-based combinations 
with either HMA or low dose cytarabine, the complete remission (CR) and/or complete remission 
with incomplete count recovery (CRi) rate ranged from 30% to 55%. While responses are observed, 
the duration of response (DOR) (range: 5.6 to 6.4 months) is limited. Furthermore, median OS 
with venetoclax-based combinations is limited with a range of 3.6 to 7.2 months {DiNardo 2019, 
Kim 2020, Shoukier 2019}, which are similar to those observed with azacitidine alone {Hunter 
2019}. In contrast, the median OS is approximately 10 months for all untreated AML patients 
unfit for intensive therapy treated with azacitidine {Dombret 2015} and approximately 
15 months for all unfit patients treated with venetoclax + azacitidine {DiNardo 2020a}.


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Patients treated with intensive chemotherapy have similarly poor outcomes (median survival 
6.8 months vs 20.2 months and 2-year OS 9% vs 24% for TP53 mutant AML and TP53 wildtype 
AML, respectively) {Kadia 2016}. The CR rate after induction chemotherapy is only 28% in 
TP53 mutant compared to 50% in wildtype patients, and the median OS was 4.1 months in TP53 
mutant AML {Rucker 2012}. Despite evaluation of multiple therapies in this TP53 mutant 
population, the overall efficacy and prognosis remains consistently poor {Hunter 2019}, 
demonstrating the uniformly poor survival for this patient group. Thus, current available 
therapies have limited benefit for TP53 mutant AML patients with no therapies approved 
specifically for this population.
Cluster of differentiation 47 (CD47) is a key molecule mediating cancer cell evasion of innate 
immune surveillance. CD47 expression is a well-characterized mechanism by which cancer cells, 
including cancer stem cells, overcome phagocytosis due to intrinsic expression of prophagocytic 
“eat me” signals {Jaiswal 2009, Majeti 2009}. The progression from normal cell to cancer cell 
involves changes in genes and gene expression that trigger programmed cell death and 
programmed cell removal {Chao 2012}. Many of the steps in cancer progression subvert the 
multiple mechanisms of programmed cell death, and the expression of the dominant 
antiphagocytic signal, CD47, may represent an important checkpoint {Chao 2012}. Increased 
CD47 expression was identified first on leukemic stem cells in human AML {Majeti 2009}, and 
since then, it has been found that CD47 expression is increased on the surface of cancer cells in a 
diverse set of human tumor types.
In mouse xenograft models, CD47-blocking monoclonal antibodies (mAbs) inhibit human 
xenograft tumor growth and metastasis by enabling the phagocytosis and elimination of cancer 
cells from various hematologic malignancies and solid tumors {Chao 2011a, Chao 2010a, Chao 
2011b, Edris 2012, Kim 2012, Majeti 2009, Willingham 2012}. Binding of CD47 expressed by 
cancer cells to its ligand, signal regulatory protein alpha (SIRPα), expressed on phagocytes leads 
to inhibition of tumor cell phagocytosis. Thus, blockade of the CD47 SIRPα-signaling pathway 
by an anti-CD47 antibody leads to phagocytosis and elimination of tumor cells. Selective 
targeting of tumor cells by an anti-CD47 antibody is due to the presence of prophagocytic signals 
expressed mainly on tumor cells and not on normal cell counterparts {Chao 2010b}. In addition, 
the anti-CD47 antibody can induce an anti-cancer T-cell response through cross-presentation of 
tumor antigens by macrophage and antigen-presenting cells after tumor cell phagocytosis {Liu 
2015b, Tseng 2013}.
1.2.
Magrolimab
1.2.1.
General Information
Magrolimab is a humanized anti-CD47 mAb that blocks the interaction of CD47 with its receptor 
and enables phagocytosis of human cancer cells {Liu 2015a}. The activity of magrolimab is 
primarily dependent on blocking CD47 binding to SIRPα and not on the recruitment of 
Fc-dependent effector functions, although the presence of the immunoglobulin G4 (IgG4) Fc 
domain is required for its full activity. For this reason, magrolimab was engineered with a human 
IgG4 isotype that is relatively inefficient at recruiting Fc-dependent effector functions that might 
enhance toxic effects on normal CD47-expressing cells {Liu 2015a}. Nonclinical studies using 


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xenograft cancer models provide compelling evidence that magrolimab triggers phagocytosis and 
elimination of cancer cells from human solid tumors and hematologic malignancies. Based on 
this mechanism of action (MOA) and its potent nonclinical activity, magrolimab is being 
developed as a novel therapeutic candidate for solid tumors and hematologic malignancies.
The magrolimab program represents a novel strategy for the treatment of cancer and is the first 
therapeutic agent to target the CD47-SIRPα axis. Extensive nonclinical studies have 
demonstrated activity against both human solid tumors (breast, ovarian, pancreas, colon, 
leiomyosarcoma, bladder, prostate, and others) and hematologic malignancies (AML, acute 
lymphoblastic leukemia, non-Hodgkin lymphoma [NHL], myeloma, myelodysplastic syndrome 
[MDS], and others).
For further information on GS-4721 (magrolimab), refer to the current investigator’s brochure 
(IB).
1.2.2.
Nonclinical Pharmacology and Toxicology
The combination of magrolimab + azacitidine was evaluated in leukemic nonclinical models. 
Nonclinical synergy was observed based on the upregulation of prophagocytic signals (including 
calreticulin) on leukemic cells of a TP53 mutated cell line by azacitidine combined with 
blockade of the anti-phagocytic signal CD47 with magrolimab {Feng 2018}. 
Magrolimab + azacitidine led to synergistic phagocytosis of leukemic cells in vitro and near 
100% long-term durable remissions in an aggressive nonclinical leukemia mouse model, 
compared to modest effects with either monotherapy. These data support the mechanistic and 
nonclinical rationale for combining magrolimab with azacitidine in AML. Further nonclinical 
data including efficacy, toxicology, and pharmacology can be found in the IB.
1.2.3.
Clinical Background for Magrolimab
1.2.3.1.
Summary of Clinical Pharmacology
Clinical pharmacokinetic (PK) data have been collected in all ongoing studies of magrolimab 
conducted to date. Pharmacokinetic data have been analyzed in Phase 1 study (SCI-CD47-001) 
in patients with solid tumor. In this study, patients were treated with weekly magrolimab doses 
ranged from 0.1 to 45 mg/kg, with increasing plasma concentrations associated with increasing 
dose. Nonlinear PK consistent with target-mediated clearance was observed over this dose range. 
However, at maintenance doses of 10 mg/kg and above, target-mediated clearance was saturated 
within the dosing regimen, and trough levels associated with magrolimab efficacy in nonclinical 
studies were achieved. Nine of 88 (10%) evaluable patients tested positive for antidrug antibody 
(ADA) against magrolimab at any time point including baseline; ADA positivity had no impact 
on PK or clinical safety in these patients.
In the Phase 1 AML study (SCI-CD47-002), similar to the solid tumor Phase 1 study, nonlinear 
PK consistent with target-mediated clearance was observed. Three of 20 (15%) evaluable 
patients tested positive for ADA against magrolimab at any time point including baseline; ADA 
positivity had no impact on PK. Antidrug antibody positivity in either study was not associated 
with increased adverse events (AEs).


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Preliminary PK data of magrolimab from other ongoing studies (5F9003, 5F9004, and 5F9005) 
of magrolimab indicates similar PK properties across all tumor populations and in the presence 
of coadministered drugs. Across all studies, 21 of 264 (8%) patients tested positive for ADA 
against magrolimab at any time point including baseline. Antidrug antibody positivity was not 
associated with changes in PK or AE profile.
A preliminary population PK analysis of combined magrolimab PK data indicated that results for 
magrolimab population PK were typical of other nonlinear antibodies. No clinically significant 
covariates of PK variability were identified.
1.2.3.2.
Summary of Clinical Safety
Magrolimab is administered as an intravenous (IV) infusion and it is currently being studied in 
7 clinical studies. Two completed single-agent Phase 1 studies include Study SCI-CD47-001 in 
patients with advanced solid tumors and lymphomas, and Study SCI-CD47-002 in patients with 
relapsed/refractory AML, along with 2 Phase 1b partnered studies in AML as well as urothelial 
carcinoma. Five combination studies include the following: Study 5F9003, a Phase 1b/2 study of 
magrolimab with rituximab in patients with relapsed/refractory NHL; Study 5F9004, a Phase 
1b/2 study of magrolimab with cetuximab in solid tumor and colorectal cancer patients; 
Study 5F9005, a Phase 1b study of magrolimab with azacitidine in AML and MDS patients; 
Study 5F9006, a Phase 1b study of magrolimab with avelumab in solid tumor and ovarian cancer 
patients, and Study 5F9009, ENHANCE: A Randomized, Double-blind, Multicenter Study 
Comparing Magrolimab in Combination with Azacitidine versus Azacitidine Plus Placebo in 
Treatment-naïve Patients with Higher Risk Myelodysplastic Syndrome.
As of July 2020, over 500 patients have been treated with magrolimab. Overall, the safety profile 
has been acceptable with magrolimab as monotherapy or in combination, with no maximum 
tolerated dose (MTD) reached in any study with dosing up to 45 mg/kg. Two anticipated adverse 
reactions included on-target anemia and infusion-related reactions, which are expected with 
monoclonal antibodies. Importantly, on-target anemia due to CD47 blockade-mediated red blood 
cell (RBC) clearance was mitigated with a priming/maintenance dose strategy. The average 
hemoglobin decline with the first (priming) dose was 0.4 g/dL, with many patients improving 
their hemoglobin on therapy with a decrease in RBC transfusion requirements.
As of December 2020, 52 untreated induction chemotherapy-ineligible AML patients have been 
enrolled in Study 5F9005 and received the combination of magrolimab + azacitidine {Sallman 
2020b}. The safety profile of magrolimab in combination with azacitidine was acceptable and 
consistent with azacitidine monotherapy, with no significant increases in cytopenias, or immune-
related AEs. No MTD was reached with magrolimab dosing of 30 mg/kg weekly. The most 
common treatment-related AEs with magrolimab were anemia (31%), fatigue (19%), blood 
bilirubin increased (19%), neutropenia (19%), thrombocytopenia (17%), and nausea (15%). 
Treatment discontinuation due to any drug-related AEs occurred in 2 of 52 patients (3.8%).


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1.2.3.3.
Summary of Clinical Efficacy
In Study 5F9005, clinical activity was assessed for magrolimab + azacitidine in patients with 
treatment-naive/unfit AML and treatment-naive intermediate to higher risk (by Revised 
International Prognostic Scoring System [IPSS-R]) MDS {Sallman 2020b}. As of 
December 2020, a total of 52 AML patients (including 65% with TP53 mutation) were treated 
with magrolimab + azacitidine and 34 of them were evaluable for efficacy. The objective 
response rate (ORR) was 65% (22 patients), with 44% achieving a CR, 12% achieving CRi, 3% 
achieving partial response, and 6% achieving morphologic leukemia-free state (MLFS). Time to 
response was rapid with a median of 2.04 months. Of the responding patients who had abnormal 
cytogenetics at baseline, 47% achieved complete cytogenetic response. Additionally, 37% of 
responding AML patients achieved minimal residual disease (MRD) negativity, as assessed by 
multiparametric flow cytometry {Sallman 2020b}.
In AML patients harboring TP53 mutations, the ORR was 71% (15 of 21 patients) with a CR rate 
of 48% (10 of 21 patients), 19% (4 of 21 patients) of patients achieving CRi, and 5% (1 of 
21 patients) achieving MLFS. Median follow-up for patients with TP53-mutant AML was 
4 months, the median DOR was 9.9 months (range: 0.03+ to 15.1+ months ongoing), and the 
median OS for TP53-mutant patients (n = 34) was 12.9 months (range: 6.24 months, not 
reached) {Sallman 2020b}.
For further clinical efficacy and safety information for magrolimab in other indications, please 
refer to the magrolimab IB.
1.3.
Information About Venetoclax and Azacitidine 
1.3.1.
Description of Venetoclax
Venetoclax is a selective, orally bioavailable, small-molecule Bcl-2 family inhibitor that binds 
with high affinity (inhibitory constant [Ki] < 0.010 nM) {Souers 2013}.
Anti-apoptotic Bcl-2 family members are associated with tumor initiation, disease progression, and 
chemotherapy resistance {Fesik 2005}. Overexpression of Bcl-2 has been demonstrated in AML and 
chronic lymphocytic leukemia (CLL) cells where it mediates cell survival and resistance to 
chemotherapeutic agents. Venetoclax restores apoptosis by binding to Bcl-2 protein, thereby 
displacing proapoptotic proteins such as Bim, triggering mitochondrial outer membrane 
permeabilization and the activation of caspases. Venetoclax has demonstrated cell killing activity 
against patient-derived CLL cells and AML cells and a variety of lymphoma and leukemia cell lines.
In the US, venetoclax is approved for the treatment of adult patients with CLL or small 
lymphocytic leukemia. Venetoclax in combination with azacitidine, decitabine, or low-dose 
cytarabine is approved for the treatment of newly diagnosed AML in adults who are age ≥ 75 years 
of age, or who have comorbidities that preclude use of intensive induction chemotherapy 
{VENCLEXTA 2020}. 


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In the European Union (EU), venetoclax monotherapy is approved for the treatment of adult 
patients with CLL, and for use in combination with hypomethylating agents for the treatment of 
adult patients with newly diagnosed AML who are ineligible for intensive chemotherapy. For 
additional information on venetoclax, please refer to the prescribing information.
1.3.2.
Description of Azacitidine
Azacitidine is a nucleoside analog, specifically a chemical analog of cytidine. Azacitidine has 
2 known primary antineoplastic MOAs: 1) inhibition of DNA methyltransferase leading to 
hypomethylation of DNA and 2) direct cytotoxicity of malignant hematopoietic cells through cell 
death via its incorporation into DNA and RNA.
Azacitidine is a SOC and approved in the US for treatment of subtypes of MDS including, but 
not limited to, MDS with refractory anemia with excess blasts, a subtype that is mostly 
composed of patients with intermediate to very high risk MDS by IPSS-R criteria {VIDAZA 
2018}. Azacitidine is also an SOC therapy for previously untreated patients with AML who are 
ineligible for induction chemotherapy or SCT based on age, comorbidities, or other factors. In 
Europe, azacitidine is approved for patients with intermediate-2 and high-risk MDS according to 
International Prognostic Scoring System criteria and for patients with AML who are ineligible 
for SCT. For additional information on azacitidine, please refer to the prescribing information.
1.3.3.
Clinical Data for Venetoclax + Azacitidine
Venetoclax in combination with azacitidine (N = 84) or decitabine (N = 31) was studied in 
M14-358, a non-randomized, open-label clinical studies with newly diagnosed AML 
{VENCLEXTA 2020}. Of those patients, 67 who received azacitidine combination were aged 
≥ 75 years or had comorbidities that precluded the use of intensive induction chemotherapy. 
Patients received venetoclax via a daily ramp-up to a final 400 mg once daily dose and 
azacitidine at the standard dosing. Twenty-five percent (37 of 67) of patients receiving 
venetoclax + azacitidine achieved CR (95% CI: 26-50), and 16% (24 of 67 patients) (95% CI: 
14-36) achieved CR with partial hematologic recovery (CRh). The median follow-up was 
7.9 months (range: 0.4-36 months) for venetoclax in combination with azacitidine. At the time of 
analysis, for patients who achieved a CR, the median observed time in remission was 5.5 months 
(range: 0.4-30 months). Median time to first CR or CRh for patients treated with venetoclax in 
combination with azacitidine was 1.0 month (range: 0.7-8.9 months). Of patients treated with 
venetoclax in combination with azacitidine, 7.5% (5 of 67) subsequently received SCT. The 
study enrolled 35 additional patients (age range: 65-74 years) who did not have known 
comorbidities that preclude the use of intensive induction chemotherapy and were treated with 
venetoclax in combination with azacitidine (N = 17) or decitabine (N = 18). For the 17 patients 
treated with venetoclax in combination with azacitidine, the CR rate was 35% (95% CI: 14-62) 
and the CRh rate was 41% (95% CI: 18-67). Seven (41%) patients subsequently received SCT. 
For the 18 patients treated with venetoclax in combination with decitabine, the CR rate was 56% 
(95% CI: 31-79). The most common AEs of any grade observed with patients treated with 
venetoclax and azacitidine were nausea, diarrhea, constipation, neutropenia, thrombocytopenia, 
hemorrhage, peripheral edema, vomiting, fatigue, febrile neutropenia, rash, and anemia.


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The Phase 3 randomized, double-blind, placebo-controlled study VIALE-A, investigating 
venetoclax in combination with azacitidine versus azacitidine + placebo in treatment-naive AML 
patients who are ineligible for intensive chemotherapy, confirms the efficacy of 
venetoclax + azacitidine with a statistically significant improvement in overall OS. Median OS 
of the venetoclax + azacitidine arm was 14.7 months, while the median OS of the 
azacitidine + placebo arm was 9.6 month leading to a hazard ratio (HR) of 0.66 (95% CI: 
0.52-0.85; P < 0.001) {DiNardo 2020b}. Safety of the combination in VIALE-A was similar to 
what had been previously reported and can be managed with standard supportive care.
Despite these significant improvements in outcomes for these patients, TP53-mutated AML 
patients did not appear to benefit significantly from a venetoclax + HMA combination. 
Treatment with venetoclax in combination with an HMA as frontline therapy in TP53-mutated 
AML patients resulted in an improvement in CR with a CR/CRi rate of 47% but the durability 
was brief (median CR/CRi duration of 5.6 months). The median OS for newly diagnosed patients 
with TP53-mutated AML treated with venetoclax + HMA was 5.2 to 7.2 months, which is 
similar to treatment with HMA alone {DiNardo 2019, Kim 2020}.
1.4.
Information About 7 + 3 Regimen
1.4.1.
Description of Cytarabine
Cytarabine is a cytotoxic drug that primarily kills cells undergoing DNA synthesis (S phase) and 
under certain conditions blocks the progression of cells from G1 phase to S phase. It acts through 
the inhibition of DNA polymerase and incorporates in limited but significant amount in DNA 
and RNA.
Cytarabine in combination with other approved anticancer drugs (such as anthracyclines) is 
indicated for remission induction in AML.
For additional information on cytarabine, please refer to the prescribing information.
1.4.2.
Description of Daunorubicin
Daunorubicin is an anthracycline cytotoxic antibiotic that has an antimitotic and cytotoxic 
activity through several mechanisms: it forms complexes with DNA by intercalation between 
base pairs, inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, 
inhibits polymerase activity, affects regulation of gene expression, and produces free radical 
damage to DNA.
Daunorubicin hydrochloride in combination with cytarabine is indicated for the remission 
induction in AML.
For additional information on daunorubicin, please refer to the prescribing information.


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1.4.3.
Description of Idarubicin
Idarubicin is a DNA-intercalating analog of daunorubicin that has an inhibitory effect on nucleic 
acid synthesis and interacts with the enzyme topoisomerase II.
Idarubicin hydrochloride in combination with cytarabine is indicated for the treatment of AML.
For additional information on idarubicin, please refer to the prescribing information.
1.4.4.
Clinical Data for 7 + 3 Regimen
The standard induction regimen used for AML patients appropriate for intensive treatment is 
based on cytarabine plus an anthracycline. 7 + 3 induction chemotherapy is one of the most 
commonly used chemotherapy regimens for intensive treatment. In most studies, using this 
combination, 60% to 70% of patients with all-comers AML achieved CR {National 
Comprehensive Cancer Network (NCCN) 2020}. However, in TP53-mutated AML, the response 
rate with 7 + 3 chemotherapy or similar intensive chemotherapy results in a much lower CR rate 
(28%) with the median OS of 4.1 to 6.8 months {Kadia 2016, Rucker 2012}.
1.5.
Rationale for This Study
Patients with TP53-mutated AML have very poor prognosis and are largely incurable both with 
intensive treatment and non-intensive therapies. The majority of patients previously untreated for 
AML are > 60 years of age. Due to age-related comorbidities, these patients often are ineligible 
for aggressive induction chemotherapy and hematopoietic SCT due to a significantly increased 
risk of treatment-related mortality. Instead, SOC for these patients is treatment with HMAs (eg, 
azacitidine), which have a lower risk of toxicity. However, these treatments are rarely curative 
and provide a treatment benefit of a median OS around only 10 months {Dombret 2015}. 
Venetoclax in combination with HMA or low-dose cytarabine was recently approved under the 
accelerated approval pathway by the US FDA, offering an efficacious alternative to HMAs 
alone. Despite these advances, AML patients harboring a TP53 mutation have a particularly poor 
prognosis and are refractory to available therapies. To this point, median survival in TP53 mutant 
AML patients ineligible for intensive induction chemotherapy is only about 5 to 7 months 
{DiNardo 2019} with similar outcomes in patients treated with intensive chemotherapy {Kadia 
2016, Rucker 2012}. Thus, there is intense interest to improve the current SOC with therapies 
that augment antileukemic activity in previously untreated AML patients harboring a TP53 
mutation.
Given the encouraging preliminary efficacy demonstrated by magrolimab + azacitidine in 
previously untreated TP53 mutant AML patients in the 5F9005 study, the magrolimab in 
combination with azacitidine provides a potential benefit in this patient population and is 
therefore the appropriate experimental arm. The control arm of venetoclax + azacitidine for 
non-intensive therapy is selected based on this combination being the current or emerging SOC 
therapy option for this patient population. This selection rationale is based on the fact that 
venetoclax + azacitidine is the current SOC option in the US based on accelerated approval by 
the FDA in 2018 for untreated AML patients who are ineligible for intensive induction 


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chemotherapy (inclusive of TP53 mutation status). Furthermore, results from VIALE-A, a global 
randomized Phase 3 study comparing venetoclax + azacitidine compared with azacitidine + 
placebo has demonstrated OS superiority of venetoclax + azacitidine compared to azacitidine 
monotherapy in untreated AML patients who are ineligible for intensive induction chemotherapy 
{DiNardo 2020b}. Therefore, venetoclax + azacitidine is the recommended treatment option for 
this population in several region-specific practice guidelines. Venetoclax + HMA or cytarabine is 
a preferred regimen in the US {National Comprehensive Cancer Network (NCCN) 2020}. In 
Europe, venetoclax + HMA or cytarabine, while not yet approved, is considered superior to 
currently available first-line treatments, with a class IIIA evidence recommendation {Heuser 
2020}. Venetoclax in combination with azacitidine for treatment of previously untreated AML 
patients who are ineligible for intensive induction chemotherapy is anticipated to be approved 
shorted in the EU as well as other regions. For patients who are appropriate for intensive 
chemotherapy, the most widely used SOC is 7 + 3 chemotherapy {Dohner 2017, National 
Comprehensive Cancer Network (NCCN) 2020}.
1.6.
Rationale for Dose Selection of Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK-pharmacodynamic data, and modelling and simulation analyses based on data obtained 
from all ongoing and completed clinical studies with magrolimab in patients with solid tumors, 
NHL, and AML/MDS.
In the first-in-human study of magrolimab (SCI-CD47-001) in patients with solid tumors and 
lymphomas, after an initial priming dose of 1 mg/kg on the first day, magrolimab was tested as a 
monotherapy at weekly doses of up to 45 mg/kg. The use of an initial 1 mg/kg priming dose was 
integrated into the dosing regimen to mitigate the on-target anemia induced by CD47 blockade. 
An initial priming dose leads to elimination of aged RBCs that are sensitive to CD47 blockade 
and triggers reticulocytosis of young RBCs that are not affected by CD47 blockade {Chen 
2018}. Utilizing a priming dose leads to an initial, transient, and mild anemia that generally 
normalizes back to baseline over several weeks, even in the presence of repeated therapeutic 
doses of magrolimab {Advani 2018, Liu 2015a, Sikic 2019}. The maximum dose of 45 mg/kg 
has an acceptable safety profile, and no MTD was identified in this study. In 
Studies SCI-CD47-002 and 5F9005 in patients with AML/MDS, magrolimab was administered 
as a monotherapy at doses of up to 30 mg/kg twice weekly and in combination with azacitidine 
at doses of up to 30 mg/kg once weekly. In these studies, no significant dose-limiting toxicity 
was observed, and magrolimab had an acceptable safety profile over the tested dose range up to a 
maximum of 30 mg/kg twice a week. Furthermore, in these 2 studies, an intrapatient dose 
escalation approach was followed; after the priming dose, the patients received doses of 
15 mg/kg on Day 8 during Week 2, after which the dose was escalated to 30 mg/kg on 
Day 11 and then weekly thereafter. This was based on nonclinical data indicating enhanced 
safety of intrapatient dose escalation. In Studies 5F9003 and 5F9004, magrolimab, in 
combination with rituximab and cetuximab, respectively, was found to have an acceptable safety 
profile at doses up to 45 mg/kg every week followed by every other week. The proposed dosing 
regimen of magrolimab in this study is expected to have an acceptable safety profile based on the 
entirety of safety data in multiple oncology populations including the MDS/AML population, both 
as a monotherapy and in combination with other tumor targeted antibodies and chemotherapeutics.


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In Study SCI-CD47-002 and Study 5F9005, CD47 receptor occupancy (RO) by magrolimab was 
tested at baseline and at multiple time points on ti·eatment, on both peripheral blood and bone 
manow cells, including leukemic blasts. A PK-phannacodynamics model linking dose exposure 
and blood and bone maiTow RO was developed and described these data well. Simulations with 
the model predicted that > 90% RO would be achieved in the bone manow cells at the 
magrolimab dosing regimen proposed in this study. This level of RO is typically associated with 
maximal efficacy for all immune-oncology antibodies. Therefore the ro osed dose re imen is 
ex ected to maximize efficac in the MDS atient o ulation. 
Based on results from the Phase 1 b study of magrolimab in MDS and AML (Study 5F9005), the 
cmTent study is designed to employ the same inti·apatient dose escalation regimen for 
magrolimab in combination with azacitidine in ti·eatment-naive patients with AML to mitigate 
on-tai·get toxicities such as anemia and other toxicities observed in nonclinical AML models. The 
inu-apatient dose escalation regimen uses initial twice-weekly dosing at a staiiing magrolimab 
dose of 1 mg/kg for Week 1 (Days 1 and 4), with escalation to 15 mg/kg on Day 8 and 30 mg/kg 
on Days 11, 15, and 22 of Cycle 1. In Cycle 2, the dose is 30 mg/kg weekly (Days 1, 8, 15, and 
22), thereafter. In Cycle 3 and beyond, the dose is 30 mg/kg eve1y 2 weeks (Q2W) on Days 1 
and 15. Treatment should be continued until disease progression, relapse, loss of clinical benefit, 
or unacceptable toxicities occur. The sti·ategy of inti·apatient dose escalation was found to result 
in both mitigation of acute toxicities seen in nonclinical models and in expected RBC toxicities 
that were manageable for this patient population. 
In summaiy, the proposed dose regimen has been shown to have an acceptable safety profile in 
multiple oncology patient populations, including MDS and AML patients. Based on 
PK-phaimacodynainics modelling, the proposed dose is predicted to result in optimal efficacy in 
this population. Fmi her increases in dose beyond 30 mg/kg are not predicted to result in 
increased efficacy. 
1.7. 
Risk/Benefit Assessment for the Study 
Anemia, neuu-openia, thrombocytopenia, and infections ai·e known adverse diug reactions 
associated with both azacitidine and magrolimab. The monitoring and management guidelines 
for these potential overlapping toxicities are provided in Section 5.10.1. Based on the high 
frequency of disease-related anemia in AML patients and the ability to safely manage patients 
with anemia on magrolimab with u-ansfusions in the 5F9005 study in AML patients, the potential 
overlapping toxicity of anemia can be managed to ensure patient safety in this study. 
Furthe1more, more than 52 unfit AML patients, including 34 TP53 mutant patients have been 
ti·eated with magrolimab + azacitidine, in which the safety profile is generally comparable to 
azacitidine monotherapy. In addition, specific clinical and laborato1y monitoring of magrolimab 
and azacitidine-related toxicities will be implemented to closely monitor potential AEs. 
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Magrolimab alone or in combination with azacitidine will be investigated in previously untreated 
AML patients. The nonclinical evidence of magrolimab activity (alone or in combination with 
azacitidine), the safety profile of magrolimab + azacitidine in AML patients, and preliminary 
clinical efficacy suggest that magrolimab has an acceptable risk-benefit profile for AML patients 
with TP53 mutations.
The potential risks and mitigations associated with patients being unable to attend study visits as 
a result of a pandemic have been identified for this study and are described in Appendix 3. Given 
the risk mitigation measures that are being implemented, the expected benefit-risk assessment to 
the patient remains unchanged.
1.8.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES AND ENDPOINTS
The objectives and endpoints for this study are provided in Table 1.
Table 1
Study Objectives and Endpoints
Objective
Endpoint
Primary:
To compare the efficacy of magrolimab + azacitidine 
versus venetoclax + azacitidine in patients with 
previously untreated TP53 mutant acute myeloid 
leukemia (AML) who are appropriate for non-
intensive therapy as measured by overall survival 
(OS).
Overall Survival in the Stratum of Patients Appropriate 
for Non-intensive Therapy: The OS is measured from 
the date of randomization to the date of death from any 
cause. Those whose deaths are not observed during the 
study will be censored at their last known alive date.
Secondary:
To compare the efficacy of magrolimab + azacitidine 
versus physician’s choice of venetoclax + azacitidine 
or 7 + 3 chemotherapy in all patients with previously 
untreated TP53 mutant AML as measured by OS.
Overall Survival in All Patients: The OS is measured 
from the date of randomization to the date of death from 
any cause. Those whose deaths are not observed during 
the study will be censored at their last known alive date.
To compare the efficacy of magrolimab + azacitidine 
versus physician’s choice of venetoclax + azacitidine 
or 7 + 3 chemotherapy in all patients as measured by 
event-free survival (EFS).
Event-Free Survival in All Patients: The EFS is defined 
as time from the date of randomization to the earliest 
date of documented relapse from CR, treatment failure 
(defined as failure to achieve CR within 6 months of 
treatment with magrolimab + azacitidine or venetoclax 
+ azacitidine, or up to 2 months of treatment with 7 + 3 
chemotherapy), or death from any cause. Response 
assessments or death post SCT or new anti-AML 
therapies will be included. Those who are not observed 
to have one of these events during the study will be 
censored at the date of their last response assessment 
with clear documentation of no relapse during the study. 
The date of randomization will be assigned as the event 
date for patients with treatment failure.
To compare the efficacy of magrolimab + azacitidine 
versus physician’s choice of venetoclax + azacitidine 
or 7 + 3 chemotherapy as measured by rate of 
complete remission (CR) within 2 months of 
treatment for patients treated with 7 + 3 chemotherapy 
and within 6 months of treatment for other patients.
Rate of CR within 6 months in All Patients (2 months 
for patients receiving 7 + 3 chemotherapy): The rate of 
CR is the proportion of patients who achieve a CR, 
including CR without minimal residual disease 
(CRMRD−) and CR with positive or unknown minimal 
residual disease (CRMRD+/unk) within 6 months of 
treatment with magrolimab + azacitidine or venetoclax 
+ azacitidine, or within 2 months of treatment with 7 + 3 
chemotherapy, as defined by investigators based on 
European LeukemiaNet (ELN) 2017 AML with 
modifications (Appendix 6), while on study prior to 
initiation of any new anti-AML therapy or SCT.


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Objective
Endpoint
To compare the efficacy of magrolimab + azacitidine 
versus physician’s choice of venetoclax + azacitidine 
or 7 + 3 chemotherapy as measured by rate of CR 
without minimal residual disease (CRMRD−) within 
2 months of treatment for patients treated with 7 + 3 
chemotherapy and within 6 months of treatment for 
other patients.
Rate of CR without Minimal Residual Disease within 
6 months in All Patients (2 months for patients receiving 
7 + 3 chemotherapy): The rate of CRMRD− is the 
proportion of patients who achieve a CRMRD− within 
6 months treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or within 2 months of 
treatment with 7 + 3 chemotherapy, as defined by 
investigators based on ELN 2017 AML with 
modifications (Appendix 6), while on study prior to 
initiation of any new anti-AML therapy or SCT.
To compare the efficacy of magrolimab + azacitidine 
versus physician’s choice of venetoclax + azacitidine 
or 7 + 3 chemotherapy in all patients as measured by 
the rate of CR + complete remission with partial 
hematologic recovery (CRh) within 2 months of 
treatment for patients treated with 7 + 3 chemotherapy 
and within 6 months of treatment for other patients.
Rate of CR + CRh within 6 months in All Patients 
(2 months for patients receiving 7 + 3 chemotherapy): 
The CR + CRh rate is the proportion of patients who 
achieve a CR (including CRMRD− and CRMRD+/unk) or 
CRh as defined by CR with partial platelet and absolute 
neutrophil count recovery (Appendix 6) within 6 months 
of treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or within 2 months of 
treatment with 7 + 3 chemotherapy while on study prior 
to initiation of any new anti-AML therapy or SCT.
To evaluate the duration of complete remission 
(DCR) in patients who achieved CR within 6 months 
of treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or within 2 months of 7 + 3 
chemotherapy.
Duration of Complete Remission: The DCR is measured 
from the time the assessment criteria are first met for 
CR (including CRMRD− and CRMRD+/unk) within 6 months 
of treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or within 2 months of 
treatment with 7 + 3 chemotherapy until the first date of 
AML relapse or death (including assessments post 
SCT). Those who are not observed to have relapsed 
disease or death while on study will be censored at the 
date of their last response assessment with no evidence 
of relapse. If patients start taking new anti-AML 
therapies (excluding maintenance therapy) before 
relapse, the DCR will be censored at the last response 
assessment before the initiation of the new anti-AML 
therapies.
To evaluate the duration of CR + CRh in patients who 
achieved CR or CRh within 6 months of treatment 
with magrolimab + azacitidine or venetoclax + 
azacitidine, or within 2 months of 7 + 3 
chemotherapy.
Duration of CR + CRh: The duration of CR + CRh is 
measured from the time the assessment criteria are first 
met for CR (including CRMRD− and CRMRD+/unk) or CRh 
within 6 months of treatment with magrolimab + 
azacitidine or venetoclax + azacitidine, or within 
2 months of treatment with 7 + 3 chemotherapy until the 
first date of AML relapse or death (including 
assessments post SCT). Those who are not observed to 
have relapsed disease or death while on study will be 
censored at the date of their last response assessment 
with no evidence of relapse. If patients start taking new 
anti-AML therapies (excluding maintenance therapy) 
before relapse, the duration of CR + CRh will be 
censored at the last response assessment before the 
initiation of the new anti-AML therapies.


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Objective 
To assess the safety and tolerability of magrolimab + 
azacitidine versus physician's choice ofvenetoclax + 
azacitidine or 7 + 3 chemotherapy. 
To evaluate the phannacokinetics and 
immunogenicity of magrolimab. 
Endpoint 
Final 
Amendment5 
Incidence of Grade c:: 3 treatment-emergent adverse 
events 
Incidence of Grade c:: 3 treatment-emergent laboratory 
abno1malities 
Semm concentration of magrolimab 
Rate of anti-magrolimab antibody incidence 
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3.
STUDY DESIGN
3.1.
Endpoints
The endpoints of this study are described in Table 1.
3.2.
Study Design
This is a Phase 3, randomized, open-label, multicenter study comparing 
magrolimab + azacitidine and venetoclax + azacitidine (for patients who are appropriate for 
non-intensive therapy) or 7 + 3 chemotherapy (for patients who are appropriate for intensive 
therapy) in patients with previously untreated TP53 mutant AML. Approximately 346 patients 
will be randomized in 1:1 ratio to receive either magrolimab + azacitidine (experimental arm) or 
physician’s choice of venetoclax + azacitidine or 7 + 3 chemotherapy (control arm). 
Randomization will be stratified by 3 factors: 1) appropriateness for non-intensive therapy versus 
intensive therapy; 2) age (< 75 years, ≥ 75 years); 3) geographic region (US sites, outside the US 
sites). The primary endpoint of this study is OS in the stratum of patients appropriate for 
non-intensive therapy and the key secondary endpoint will be OS in all patients. The primary 
analysis of OS will be conducted when 171 deaths have occurred in the stratum of patients 
appropriate for non-intensive therapy. An interim futility analysis and an interim superiority 
analysis will be conducted separately after approximately 69 and 128 deaths (40% and 75% of 
the expected 171 deaths, respectively) in the stratum of patients appropriate for non-intensive 
therapy have occurred. 
In the event the study meets futility, the sponsor may decide to terminate the study, and 
recommend patients receiving treatment transition to SOC therapy. The current study met futility  
and sites were informed of the outcome and sponsor’s decision in a communication in September 
2023. Due to the study having met futility, patients are recommended to transition to SOC 
therapy. If an investigator believes that continued treatment with magrolimab + azacitidine is in 
the best interest of their patient(s), Gilead will continue to provide study drug, with a reduced 
schedule of assessments, pending final study closure; if an investigator believes that continued 
treatment with venetoclax + azacitidine is in the best interest of their patient(s), and the 
combination is not available locally as SOC, Gilead may continue to provide drug, pending final 
study closure.
Patient participation will include 
 prescreening component, screening, treatment, and 
follow-up. Screening will last up to 30 days before first dose of study treatment, during which 
time the patient’s eligibility and baseline characteristics will be determined. Patients will receive 
study treatment per the dose schedule in Table 21, Table 22, Table 23, and Table 29. No cross-
over between arms is allowed. Study treatment should be continued until disease progression, 
relapse, loss of clinical benefit, or unacceptable toxicities occur. In case patients discontinue the 
study treatment due to reasons other than disease progression or relapse, patients will be 
followed for response assessments until documented disease progression or relapse or initiation 
of new anti-AML therapy excluding SCT and maintenance. For patients who discontinue the 
study treatment to receive an SCT, follow-up for response assessment and collection of bone 
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marrow biopsy/aspirate results will continue every 12 weeks from the date of SCT until 
documented disease progression or relapse or initiation of new anti-AML therapy (excluding 
maintenance therapy). Then patients will be observed for survival until death, withdrawal of 
consent, lost to follow-up, or the end of the study, whichever occurs first.
In the event the study meets futility, and the sponsor decides to terminate the study, all patients 
who discontinue study treatment for any reason will not be followed for response or survival.
Treatment with magrolimab or venetoclax as single agent is not permitted. Patients who 
discontinue magrolimab + azacitidine, or venetoclax + azacitidine, but continue in a response or 
are achieving clinical benefit will continue to be followed on study for response assessments to 
ascertain relapse and for long-term survival.
The study schematic is presented in Figure 1.
Figure 1.
Study Schema
3.3.
Study Treatments
Table 2.
Dosing and Schedule for Magrolimab and Azacitidine Experimental 
Arm
Dose Schedule (Day per 28-day Cycle)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Azacitidine 75 mg/m2 SC or IVa
Days 1–7
or
Days 1–5 and 8, 9b
Days 1–7
or
Days 1–5 and 8, 9b
Days 1–7
or
Days 1–5 and 8, 9b
Magrolimab Administration
Magrolimab 1 mg/kg IV (over 3 hours)
Days 1, 4
Magrolimab 15 mg/kg IV (over 3 hours)
Day 8
Magrolimab 30 mg/kg IV (over 2 hours)
Days 11 and 15, and then QW x 5 weekly 30 mg/kg dose 
Magrolimab 30 mg/kg IV (over 2 hours)
Q2W beginning 1 week after the 5 weekly 30 mg/kg dose
IV = intravenous; PO = orally; Q2W = every 2 weeks; QW = once a week; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive 
days.
Tnal Population 
~
1.1 
with presence 
L 
Previously 
Untreated AML 
I 
of at least 1 
Physician's 
{ 
TP53 mutation 
choice • 
that is not benign 
\ 
'. • • • • 
_ 
11 
or likely benign 
. 
• 
Study Design 
Control 
venetoclax + azac1t1d1ne 
Randomization 
Expenmental 
magrollmab + azac1t1d1ne 
Randomization 
Stratification: 
1) Appropriateness for non-intensive therapy vs intensive therapy 
2) Age (<75 VS 2 75) 
3) Geographic region: (US vs. outside the US) 


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Table 3.
Dosing and Schedule for Venetoclax and Azacitidine Control Arm
Dose Schedule (Day per 28-day Cycle)
Control Arm
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Venetoclax 100 mg oral
Day 1
—
—
Venetoclax 200 mg oral
Day 2
—
—
Venetoclax 400 mg oral
Day 3 and daily 
thereafter
Daily
Daily
Venetoclax + 
Azacitidine
Azacitidine 75 mg/m2 SC 
or IVa
Days 1–7
or
Days 1–5 and 8–9b
Days 1–7
or
Days 1–5 and 8–9b
Days 1–7
or
Days 1–5 and 8–9b
IV = intravenous; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive 
days.
Table 4.
Dosing and Schedule for 7 + 3 Chemotherapy Control Arm
Control Arm (7 + 3)
Drug/Dose/Route
7 + 3 Induction
5 + 2 Induction, if needed (after 
C1D15 bone marrow assessment)
Daunorubicin 
60 mg/m2 IVP
or 
Idarubicin 
12 mg/m2 IV
Days 1–3
Days 1-2
Induction
Cytarabine 
100 or 200 mg/m2 
Continuous Infusion
Days 1–7
Days 1–5
Cytarabine (HiDAC) 
1500 or 3000 mg/m2 IVa
Every 12 hours on Days 1, 3, and 5
(up to 4 cycles)
Consolidation
Steroidal Eye Drops
As per institutional standard
C1D15 = Cycle 1 Day 15; HiDAC = high-dose cytarabine; IV = intravenous; IVP = intravenous peripheral
a
In some cases, patients ≥ 60 years of age can receive 1000 mg/m2 based on local practice.
The schedules of assessments are provided in Appendix 2.
3.4.
Duration of Treatment
For patients treated with magrolimab + azacitidine or venetoclax + azacitidine, cycle length is 
28 days and all patients without evidence of disease progression, relapse, loss of clinical benefit, 
or unacceptable toxicity should continue on study treatment unless they meet study treatment 
discontinuation criteria.
For patients treated with 7 + 3 chemotherapy (with or without 5 + 2 chemotherapy as indicated), 
induction followed by up to 4 cycles of consolidation with high-dose cytarabine (HiDAC) should 
be administered unless study treatment discontinuation criteria are met.
Patients will be discontinued from study treatment prior to starting SCT.


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3.5.
Discontinuation Criteria
The patient’s health and welfare are the primary consideration in any determination to 
discontinue study treatment. In general, patients are expected to remain on study treatment until 
at least completion of Cycle 6 for azacitidine or venetoclax + azacitidine treatment, and through 
induction 7 + 3 chemotherapy treatment; however, patients (or a legally acceptable 
representative) may decline to continue receiving study treatment at any time during the study. 
Such patients will continue to participate in follow-up study visits unless they withdraw 
completely from the study.
Reasons for discontinuation of study treatment must include, but are not limited to, the 
following:
•
Disease progression (including treatment failure and relapse)
•
Unacceptable toxicity
•
Loss of clinical benefit
•
Death
•
Pregnancy during the study 
•
Patient request, with or without a stated reason
•
Patient noncompliance
•
Initiation of anti-AML therapy
•
SCT
•
Investigator or treating physician decision 
•
Protocol violation
•
Lost to follow-up
•
Discontinuation of the study at the request of Gilead, a regulatory agency, or an institutional 
review board (IRB)/independent ethics committee (IEC)
Although disease progression is considered a sufficient reason for discontinuing a patient from 
study treatment, given the delayed treatment benefit commonly seen in immune therapies, the 
investigator is advised to continue to treat the patient until the investigator considers the study 
treatment to be no longer clinically beneficial to the patient, or the change of disease state 
renders the patient unacceptable for further treatment in the judgment of the investigator. 
All patients must be followed through completion of all study treatment.


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If patients remain on study drugs beyond disease progression, a second bone marrow assessment, 
along with required laboratory tests for response assessment, should be done within 4 weeks. If 
disease progression is confirmed at the second bone marrow assessment, the patient should be 
discontinued from the study treatment.
Patients who discontinue study treatment are to return for an end of treatment (EOT) visit for 
evaluation of safety within 7 days of their last dose or the decision to end study treatment, 
whichever occurs later. In addition, patients are to have a safety follow-up telephone call 30 days 
and 70 days (± 7 days) after their last dose of study treatment. When a serious adverse event 
(SAE) or treatment-related AE is reported during the telephone call, the patient should come to 
the clinic for physical examination and blood tests, if clinically needed. Follow-up for ongoing 
SAEs or treatment-related AEs after the safety follow-up visit/call will stop if a patient begins 
another anti-AML therapy.
All patients who discontinue study treatment for reasons other than disease progression or 
relapse will participate in long-term follow-up for disease response until documented disease 
progression/relapse or until start of new anti-AML therapy, unless the patient withdraws consent 
for such follow-up and withdraws completely from the study. For patients who come off the 
study treatment to receive an SCT, follow-up for response assessment and collection of bone 
marrow biopsy/aspirate results will continue until documented relapse occurs. When considering 
SCT, note that no significant magrolimab-related transplant complications have been observed in 
patients who have achieved a response and undergone SCT in an ongoing magrolimab study in 
AML and MDS (Study 5F9005); however, a 4-week wash-out period for magrolimab is 
recommended prior to SCT.
All patients will be followed for survival until the following events occur: death, withdrawal of 
formal consent, loss to follow-up, or the end of the study, whichever occurs first. For any patient 
who dies during this follow up period, the immediate cause of death must be reported to the 
sponsor. In the event the study meets futility, and the sponsor decides to terminate the study, all 
patients who discontinue study treatment for any reason will not be followed for survival; 
patients should have an EOT visit (within 7 days after last dose or EOT decision, whichever 
occurs later ± 7 days) and 30-day safety follow-up visit (± 7 days) after last dose, but the 70-day 
safety follow-up visit, post-treatment response assessments, long -term follow-up, long-term 
follow-up after SCT, and survival follow-up are not required. A final contact by telephone for 
patients who discontinued study therapy and are in long-term or survival follow-up prior to study 
termination for futility will be made.
The assessments to be performed at each of the posttreatment visits are listed in Table 24 and 
Table 28.
3.6.
End of Study
All Patients: The end of the entire study for all patients is defined as the date on which the last 
patient remaining on study completes the last study visit/call or when the sponsor decides to end 
the study. The sponsor reserves the right to terminate the study at any time for any reason 
(including safety).


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Individual Patients: Patients are considered to have reached the end of the study when they are 
no longer followed for long-term or survival follow-up due to the following reasons: death, loss 
to follow-up, withdrawal of consent, or sponsor termination of study.
3.7.
Poststudy Care 
Upon withdrawal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for survival and AEs as specified in Table 24 or 
Table 28.
For patients who start new anti-AML therapy (other than SCT and maintenance therapy) before a 
relapse, efficacy status will be collected until relapse. For patients discontinuing study treatment 
in the event of study termination due to futility, post-study anti-AML therapy status will not be 
collected and response assessments will no longer be required. 
3.8.
Source Data
The source data for this study will be obtained from original records (eg, clinic notes, hospital 
records, patient charts), local and/or specialty (eg, PK, ADA, and/or pharmacodynamics) 
laboratory testing, and/or additional biomarker testing.
3.9.
Biomarker Samples to Address the Study Objectives
Peripheral blood, bone marrow aspirate and trephine biopsy samples will be collected from all 
patients who have provided consent to participate in this study. They may be used to evaluate the 
association of systemic and/or tissue-based biomarkers with study drug response, including 
efficacy and/or AEs, dosage selection, and to better understand the biological pathways, biology 
of TP53 mutant AML or AML in general or the validation of a companion diagnostic for TP53 
mutant AML for magrolimab. Because biomarker science is a rapidly evolving area of 
investigation, and AEs in particular are difficult to predict, it may not be possible to specify 
prospectively all tests that may be done on the specimens provided. The specific analyses will 
include, but may not be limited to, the biomarkers and assays described below. The testing 
outlined below is based upon the current state of scientific knowledge. It may be modified during 
or after the end of the study to remove tests no longer indicated and/or to add new tests based 
upon new state of the art knowledge.
Blood and bone marrow samples will be collected to measure biomarkers which may include but 
will not be limited to the presence of or changes to immune cell populations, secreted protein 
factors, the expression of cell surface markers on either tumor cells or cells of the tumor 
microenvironment, and genetic mutations in tumor cells or subclones of tumor cells at the time 
points listed in the schedule of assessments (Table 20, Table 21, Table 23, and Table 24).
Samples to be collected for genomic research will be used to identify or validate genetic markers 
that may increase our knowledge and understanding of the biology of the study disease and 
related diseases, and to study the association of genetic markers with disease pathogenesis, 
progression and/or treatment outcomes, including efficacy, AEs, and the processes of drug 


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absorption and disposition. These specimens may also be used to develop biomarker or 
diagnostic assays and establish the perfonnance characteristics of these assays. Genomics 
research may include sequencing of genetic material derived from both cancer cells and nonnal 
cells. 
The specimens collected for-future research will be destroyed no later than 15 years 
after the end of study or per country requirements. 
In the event the study meets futility, and the sponsor decides to tenninate the study, additional 
peripheral blood and bone manow samples and buccal swab for biomarker research will no 
longer be collected. 
-
3.9.2. 
TP53 Mutation Testing and Companion Diagnostic Development 
Biological specimens will be collected from all patients who have provided consent to pa1ticipate 
in this study, or the prescreening phase, to determine the mutational status of the TP53 gene in 
leukemic cells and suppo1t diagnostic development using a next-generation sequencing (NGS) 
test. Patients will be emolled based on TP53 mutational status using a either Laborato1y 
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Developed Test assay that has been analytically validated in accordance with Clinical Laboratory 
Improvement Amendments (CLIA)/Clinical Laboratory Standards Institute regulations in a 
CLIA-accredited central laboratory or an approved local laboratory using NGS on bone marrow 
aspirate (after central review of test results). The test in the EU central laboratory will carry a CE 
Mark. This central testing will be performed regardless of whether TP53 status has been assessed 
as part of previous clinical diagnosis or an approved local laboratory using NGS. Collected 
samples from patients who prescreen, or screen fail due to a lack of TP53 mutation may be 
stored and used for validation of a TP53 companion diagnostic. Residual samples will be banked 
to validate diagnostic tests for TP53 status for in vitro diagnostic development.
Samples collected for TP53 mutational assessments will be destroyed no later than 15 years after 
the end of study or per country requirements.
In the event the study meets futility, and the sponsor decides to terminate the study, samples will 
not be used for validation of a TP53 companion diagnostic or banked to validate diagnostic tests 
for TP53 status for in vitro diagnostic development.


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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
The study enrollment may stop after 228 patients in the non-intensive group or approximately 
346 of all patients are enrolled, whichever occurs later. Approximately 346 patients will be 
enrolled in the study, with approximately 173 patients in the experimental arm and 173 patients 
in the control arm. In the event the study meets futility, and the sponsor decides to terminate the 
study, no further patients will be enrolled.
4.1.1.
Patient Replacement
There will be no patient replacement on this study.
4.2.
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this 
study:
1) Patients with confirmation of AML by World Health Organization criteria, previously 
untreated for AML, and who have presence of: 
a) At least 1 TP53 gene mutation that is not benign or likely benign based on evaluation by 
either central laboratory or an approved local laboratory (after central review of the bone 
marrow TP53 mutation NGS test results) 
b) Biallelic 17p deletions, loss of both 17p alleles, based on locally evaluated 
cytogenetics/karyotype/fluorescence in situ hybridization (FISH) report.
2) Patients with white blood cell (WBC) count ≤ 20 × 103/µL prior to randomization. If the 
patient’s WBC is > 20 × 103/µL prior to randomization, the patient can be enrolled, assuming 
all other eligibility criteria are met. However, the WBC should be ≤ 20 × 103/µL prior to the 
first dose of study treatment and prior to each magrolimab dose for the first 4 weeks (if the 
patient is randomized to the experimental arm).
NOTE: Patients can be treated with hydroxyurea and/or leukapheresis throughout the study 
or prior to randomization to reduce the WBC to ≤ 20 × 103/µL to enable eligibility for study 
drug dosing.
3) The hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment.
NOTE: Transfusions are allowed to meet hemoglobin eligibility (see Section 7.8.1).
4) Patient has provided informed consent.


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5) Patient is willing and able to comply with clinic visits and procedure outlined in the study 
protocol.
6) Male or female ≥ 18 years of age.
7) Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 
to 2 except for patients less than 75 years of age and appropriate for non-intensive treatment. 
For these patients, the ECOG performance status score may be 0 to 3.
8) Patients must have adequate renal function as demonstrated by a creatinine 
clearance ≥ 30 mL/min; calculated by the Cockcroft-Gault formula (Appendix 11).
9) Adequate cardiac function as demonstrated by:
a) Lack of symptomatic congestive heart failure and clinically significant cardiac 
arrhythmias and ischemic heart disease
b) Left ventricular ejection fraction (LVEF) > 50% for patients appropriate for intensive 
therapy
10) Adequate liver function as demonstrated by:
a) Aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN)
b) Alanine aminotransferase (ALT) ≤ 3.0 x ULN
c) Total bilirubin ≤ 1.5 x ULN, or primary unconjugated bilirubin ≤ 3.0 x ULN if patient 
has a documented history of Gilbert’s syndrome or genetic equivalent.
11) Pretreatment blood cross-match completed (as detailed in Section 7.8.1).
12) Male and female patients of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol-specified method(s) of contraception as described in Appendix 5.
13) Patients must be willing to consent to mandatory pretreatment and on-treatment bone marrow 
biopsies (aspirate and trephines), unless not feasible as determined by the investigator and 
discussed with the sponsor.
4.3.
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not to be enrolled in this study:
1) Subjects that are unable to give consent. To give consent, the individual concerned must be 
of legal age and be able to understand the nature, significance and implications of the clinical 
study and form their rational intentions in light of these.
2) Positive serum pregnancy test (Appendix 5). 


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3) Breastfeeding female.
4) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
5) Prior treatment with any of the following:
a) CD47 or SIRPα-targeting agents
b) Antileukemic therapy for the treatment of AML (eg, HMA, low dose cytarabine and/or 
venetoclax), excluding hydroxyurea.
NOTE: Patients with prior MDS who have not received prior HMAs or chemotherapeutic 
agents for MDS are allowed on study. Other prior MDS therapies including, but not 
limited to, lenalidomide, erythroid stimulating agents, or similar RBC-direct therapies, 
are allowed. Localized non-central nervous system (CNS) radiotherapy, erythroid and/or 
myeloid growth factors, hormonal therapy with luteinizing hormone-releasing hormone 
(LHRH) agonists for prostate cancer, hormonal therapy or maintenance for breast cancer, 
and treatment with bisphosphonates and receptor activator of nuclear factor kappa-B 
ligand inhibitors are also not criteria for exclusion.
c) Patients who are appropriate for intensive treatment but who have been previously treated 
with maximum cumulative doses of idarubicin and/or other anthracyclines and 
anthracenediones will be excluded.
6) Patients receiving any live vaccine within 4 weeks prior to initiation of study treatments.
7) For patients appropriate for intensive therapy, patients treated with trastuzumab within 
7 months prior to initiation of study treatments.
8) Current participation in another interventional clinical study.
9) Known inherited or acquired bleeding disorders.
10) Patients appropriate for non-intensive therapy who have received treatment with strong 
and/or moderate cytochrome P450 enzyme (CYP) 3A inducers within 7 days prior to the 
initiation of study treatments.
11) Patients appropriate for non-intensive therapy who have consumed grapefruit, grapefruit 
products, Seville oranges (including marmalade containing Seville oranges), or starfruit 
within 3 days prior to the initiation of study treatment.
12) Patients appropriate for non-intensive therapy, who have malabsorption syndrome or other 
conditions that preclude enteral route of administration.
13) Clinical suspicion of active CNS involvement with AML.
14) Patients who have acute promyelocytic leukemia.


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15) Significant disease or medical conditions, as assessed by the investigator and sponsor, that 
would substantially increase the risk-benefit ratio of participating in the study. This includes, 
but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, 
uncontrolled diabetes mellitus, significant active infections, and congestive heart failure 
New York Heart Association Class III-IV.
16) Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, 
localized prostate cancer, or other malignancies for which patients are not on active 
anti-cancer therapies and have had no evidence of active malignancy for at least ≥ 1 year.
NOTE: Patients on maintenance therapy alone who have no evidence of active malignancy 
for at least ≥ 1 year are eligible.
17) Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or 
HIV infection in medical history.
18) Active HBV, and/or active HCV, and/or HIV following testing at screening:
a) Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test 
positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative 
polymerase chain reaction (PCR) for confirmation of active disease.
b) Patients who test positive for HCV antibody. These patients will require HCV RNA 
quantitative PCR for confirmation of active disease.
c) Patients who test positive for HIV antibody.
d) Patients not currently receiving antiviral therapy and who have an undetectable viral load 
in the prior 3 months may be eligible for the study.


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding, and Treatment Codes Access
5.1.1.
Randomization
Patients who meet randomization eligibility criteria will be randomized in a 1:1 ratio using an 
integrated web response system to either the experimental arm or the control arm. The first dose 
of study drugs should be administered within 72 hours of randomization.
To achieve balance between treatment arms, randomization will be stratified according to the 
following factors:
•
appropriateness for non-intensive therapy versus intensive therapy
•
age (< 75 years, ≥ 75 years)
•
geographic region (US sites, outside the US sites)
5.1.2.
Blinding
Blinding of treatment assignments or data will not be performed in this study. A study data 
access plan will outline data access by various functions within the sponsor study team.
5.2.
Description and Handling of Magrolimab
5.2.1.
Formulation
Magrolimab is formulated as a sterile, clear, preservative-free liquid intended for IV 
administration containing 10 mM sodium acetate, 5% (w/v) sorbitol, 0.01% (w/v) polysorbate 20 
at pH of 5.0. Each vial is manufactured to ensure a deliverable volume of 10 mL containing 
200 mg of magrolimab at a concentration of 20 mg/mL.
5.2.2.
Packaging and Labeling
Magrolimab is supplied in single-use, 10 mL glass vials with coated elastomeric stoppers and 
aluminum crimp overseals with a flip-off cap.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.2.3.
Storage and Handling
Magrolimab should be stored at 2 C to 8 C (36 F to 46 F). Magrolimab should not be frozen. 
Protect from light during storage. Do not shake. Storage conditions are specified on the label. 
Until dispensed to the patients, study drugs should be stored in a securely locked area, accessible 
only to authorized site personnel.


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To ensure the stability and proper identification, study drug(s) should not be stored in a container 
other than the container in which they were supplied.
Consideration should be given to handling, preparation, and disposal through measures that 
minimize drug contact with the body. Appropriate precautions should be followed to avoid direct 
eye contact or exposure when handling.
5.3.
Description and Handling of Azacitidine
5.3.1.
Formulation
Azacitidine is commercially sourced. Information regarding the formulation can be found in the 
current prescribing information.
5.3.2.
Packaging and Labeling
Commercial product of azacitidine 100 mg in a single-use vial will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.3.3.
Storage and Handling
Commercial product of azacitidine will be used for the study. Further information regarding 
storage and handling are available in the local prescribing information for commercial products.
5.4.
Description and Handling of Venetoclax
5.4.1.
Formulation
Venetoclax is commercially sourced. Information regarding the formulation can be found in the 
current prescribing information {VENCLEXTA 2020}.
5.4.2.
Packaging and Labeling
Commercially available venetoclax will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.4.3.
Storage and Handling
Commercial product of venetoclax will be used for the study. Further information regarding 
storage and handling are available in the local prescribing information for commercial products.


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5.5.
Description and Handling of Cytarabine
5.5.1.
Formulation
Cytarabine is commercially sourced. Information regarding the formulation can be found in the 
current prescribing information
5.5.2.
Packaging and Labeling
Commercially available cytarabine will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.5.3.
Storage and Handling
Commercial product of cytarabine will be used for the study. Further information regarding 
storage and handling are available in the local prescribing information for commercial products.
5.6.
Description and Handling of Daunorubicin
5.6.1.
Formulation
Daunorubicin is commercially sourced. Information regarding the formulation can be found in 
the current prescribing information.
5.6.2.
Packaging and Labeling
Commercially available daunorubicin will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.6.3.
Storage and Handling
Commercial product of daunorubicin will be used for the study. Further information regarding 
storage and handling are available in the local prescribing information for commercial products.
5.7.
Description and Handling of Idarubicin
5.7.1.
Formulation
Idarubicin is commercially sourced. Information regarding the formulation can be found in the 
current prescribing information.


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5.7.2.
Packaging and Labeling
Commercially available idarubicin will be used for this study.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the US FDA, EU Guideline to Good Manufacturing 
Practice - Annex 13 (Investigational Medicinal Products), and/or other local regulations.
5.7.3.
Storage and Handling
Commercial product of idarubicin will be used for the study. Further information regarding 
storage and handling are available in the local prescribing information for commercial products.
5.8.
Dosage and Administration
The magrolimab and azacitidine dosing regimens for the experimental arm are presented in 
Table 2. 
The treatment with magrolimab+azacitidine will be administered as inpatient/outpatient based on 
local guidelines for treatment of non-intensive treatment/investigator assessment of the patient’s 
clinical status.
Azacitidine will be administered according to region-specific drug labeling, either subcutaneous 
(SC) or IV, at the standard dose of 75 mg/m2 on Days 1 to 7 of each 28-day cycle. Azacitidine 
may be administered on an alternative schedule (such as Days 1 to 5, Day 8, and Day 9 of a 
28-day cycle) for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days. When administered IV, the total dose of azacitidine 
(diluted in a 50 to 100 mL infusion bag of either 0.9% sodium chloride injection or lactated 
Ringer’s injection solution) is infused over a period of 10 to 40 minutes (refer to the azacitidine 
prescribing information for detailed instructions for preparation and administration). 
The first dose of study drugs should be administered within 72 hours after randomization.
Patients should be premedicated in accordance with Section 5.9.
Magrolimab, venetoclax, azacitidine, cytarabine, and daunorubicin or idarubicin should be 
prepared as outlined in the Pharmacy Manual for the study.
For patients taking concomitant CYP3A and P-gp inhibitors, refer to Table 12 for venetoclax 
dosing and administration.
Prior to initiation of venetoclax, WBC count must be ≤ 20  103/µL. Patients with WBC 
> 20  103/µL can be treated with hydroxyurea and/or leukapheresis throughout the study to 
reduce the WBC to ≤ 20  103/µL. 


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Venetoclax and azacitidine dosing regimens for the control arm are presented in Table 3. 
Venetoclax should be administered orally once daily with a meal and water, at approximately the 
same time each day. Patients should be advised to swallow the tablet whole, and not chew, crush 
or break the tablets. If a dose is missed and it has been less than 8 hours, patients should be 
advised to take their dose as soon as possible. If a dose is missed and more than 8 hours has 
passed, the missed dose should be skipped, and the next dose should be taken at the usual time. If 
a patient vomits after taking venetoclax, an extra dose should not be taken but rather the next 
dose should be taken at the usual time. Venetoclax will be dispensed to the patient on Day 1 of 
each treatment cycle.
The doses of magrolimab, azacitidine, daunorubicin or idarubicin, and cytarabine will be 
calculated based on actual weight at enrollment (using weight obtained either at screening or on 
Cycle 1 Day 1) and will remain constant throughout the study, unless there is a > 10% change in 
body weight from baseline. Modifications to the study treatment doses administered should be 
made for a > 10% change in body weight from baseline and according to local and regional 
prescribing standards. Dose modifications for changes in body weight < 10% may be made 
according to local institutional guidelines.
During the first 4 weeks of treatment, WBC count must be ≤ 20  103/µL prior to each 
magrolimab dose. Patients with WBC > 20  103/µL can be treated with hydroxyurea (up to 
4 g/day) and/or leukapheresis throughout the study to reduce the WBC to ≤ 20  103/µL. 
Within 24 hours prior to each of the 2 first doses of magrolimab during initial treatment, all 
patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not meet these criteria 
must be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 
2 doses of magrolimab. 
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses 
of magrolimab during initial treatment. The patient should be transfused as clinically appropriate. 
Investigators should consider additional hemoglobin monitoring during the first week of 
treatment in patients with symptoms of anemia or at increased risk for complications of anemia.
Magrolimab will be administered by IV infusion. The duration of infusion will be 3 hours 
(± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours (± 30 minutes) for infusions 
beyond the first 3 doses. The reduced infusion time to 2 hours is utilized based on prior data 
demonstrating majority CD47 RO on peripheral blood cells, thus mitigating anticipated RBC 
toxicities from magrolimab. When both magrolimab and azacitidine are given on the same visit 
day, magrolimab will be administered at least 1 hour after the completion of azacitidine 
administration.
Magrolimab doses will be given twice weekly during priming and escalation (2 weeks), with a 
window of ± 3 days for each dose; however, magrolimab doses are not to be given on 
consecutive days.


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All patients should be monitored hourly during infusion and for 1 hour post infusion for priming, 
repriming/reescalation, and maintenance doses during the first 4 weeks. Patients should be 
monitored (including measurement of vital signs, as clinically appropriate) for signs and 
symptoms of infusion-related reactions, which have been observed in previous magrolimab 
studies. Post infusion monitoring should begin after the infusion is complete. Post infusion 
monitoring is not required for doses after Day 22. Patients who experience any treatment-
emergent AEs during the observation period should be further monitored, as clinically 
appropriate. Management of infusion-related reactions is further described in Section 7.8.1.2.
Patients may continue study treatment until they show evidence of disease progression, relapse, 
loss of clinical benefit, or unacceptable toxicity (further details about treatment discontinuation 
in Section 3.5).
5.8.1.
Repriming/Reescalation for Magrolimab
Given the large CD47 antigen sink on normal cells, patients who have a long dose delay of 
magrolimab are required to be reprimed with magrolimab dosing to resaturate the CD47 antigen 
sink. Guidelines for repriming/re-escalation for magrolimab after a dose delay are provided in 
Section 5.10.1.1.
5.8.2.
7 + 3 Chemotherapy Administration
The treatment with 7 + 3 chemotherapy will be administered in the inpatient hospital setting.
The treatment plan will consist of daunorubicin at 60 mg/m2 intravenous peripheral (IVP) or 
idarubicin 12 mg/m2 by slow (10 to 15 min) IV injection on Days 1 to 3, and cytarabine at 
100 mg/m2 or 200 mg/m2 given by continuous IV infusion on Days 1 to 7. In order to determine 
whether a second induction with 5 + 2 chemotherapy is needed, patients will have a bone 
marrow examination approximately 15 days after the start of systemic chemotherapy (Induction 
Cycle 1 Day 15 ± 5 days). At that time, if the cellularity is greater than 20% and the percentage 
of blasts are greater than 10%, then re-induction with “5 + 2” (daunorubicin at 60 mg/m2 IVP or 
idarubicin 12 mg/m2 by slow IV injection on Days 1 to 2 and cytarabine at 100 mg/m2 or 
200 mg/m2 given by continuous IV infusion on Days 1-5) will be administered. Patients who 
achieve blast clearance (bone marrow blast < 5%) and a count recovery of absolute neutrophil 
count (ANC) > 1000 and platelet count > 75,000, will receive up to 4 cycles of consolidation 
with cytarabine (1500 or 3000 mg/m2 over 3 hours every 12 hours on Days 1, 3, and 5 based on 
local guidelines/institutional practice. In some cases, patients ≥ 60 years of age can receive 
1000 mg/m2 based on local practice). Consolidation should occur between 1 to 4 weeks 
following count recovery of ANC > 1000 and platelet > 75,000 after induction and remission 
(must be confirmed by laboratory assessments to document maximal response) is established. 
Prior to starting each consolidation cycle, a count recovery of ANC > 1000 and platelet 
count > 75,000 should be established. If the patient is not able to meet the requirements to 
continue the treatment schedule, the patient will enter EOT (Table 21). Stem cell transplantation 
(autologous or allogeneic) may be performed as per institutional standards for consolidation.


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Table 5.
7 + 3 Regimen Description
Induction
Agent
Dose
Route
Schedule
Daunorubicin (7 + 3)
or 
Idarubicin (7 + 3)
60 mg/m2
12 mg/m2
IVP
10-15 min IV 
Days 1-3
Cytarabine (7 + 3) 
100 or 200 mg/m2
Continuous Infusion
Days 1-7
If 5 + 2 Regimen is needed (after Cycle 1 Day 15 bone marrow assessment)
Daunorubicin (5 + 2)
or 
Idarubicin (5 + 2)
60 mg/m2
12 mg/m2
IVP
10-15 min IV 
Days 1-2
Cytarabine (5 + 2) 
100 or 200 mg/m2
Continuous Infusion
Days 1-5
Consolidation (up to 4 cycles)
Cytarabine (HiDAC)
1500 or 3000 mg/m2 a 
IV
Every 12 hours on Days 1, 3, 5
Steroidal Eye Drops
As per institutional standard
IV = intravenous; IVP = intravenous peripheral
a
In some cases, patients ≥ 60 years of age can receive 1000 mg/m2 based on local practice.
5.9.
Premedication and Prophylaxis
Premedication is required prior to the administration of the first 4 doses of magrolimab and in 
case of reintroduction with repriming. Premedications should include oral acetaminophen 650 to 
1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg or 
comparable regimen. For patients who do not experience an infusion-related reaction (IRR) with 
the first 2 doses of magrolimab, steroid pretreatment can be discontinued at investigators’ 
discretion. Patients who experience IRRs with the first 2 doses of magrolimab should continue 
premedication with corticosteroids prior to subsequent doses at the investigator’s discretion 
(Section 7.8.1.2). 
Prior to first dose of venetoclax, patients must be provided with prophylactic measures including 
adequate hydration and anti-hyperuricemic agents and continue during the ramp-up phase 
(Days 1, 2, and 3).
Prophylactic antibiotics for the prevention of neutropenic fever are not required on study for 
magrolimab+azacitidine or venetoclax+azacitidine combination treatments but may be 
administered per local institutional guidelines or investigator discretion.
For 7 + 3 chemotherapy, antibiotic prophylaxes and prophylactic measures for tumor lysis 
syndrome are to be administered per local institutional guidelines.


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5.10.
Dose Modification and Delays
5.10.1.
Magrolimab+Azacitidine (Experimental Arm)
5.10.1.1.
Magrolimab Treatment Delays
A treatment delay is defined as a non–protocol specified interruption from treatment.
Clinical safety and PK data from dose finding studies in both solid tumor and hematologic 
malignancies have not demonstrated any dose-dependent toxicities associated with magrolimab. 
Dose reduction/modification of magrolimab dosing may be allowed in certain circumstances (eg 
with certain AEs), with approval by the sponsor. If a dose reduction is considered, initial 33% 
dose reduction should be done (from 30 to 20 mg/kg). 
Dose delay guidance for magrolimab due to severe neutropenia is provided below.
•
Before achieving remission, for Grade 4 neutropenia (ANC < 500/µL) with or without 
fever or infection, delay of magrolimab dosing is not recommended. In cases of Grade 4 
neutropenia with serious infection, hold magrolimab until the infection has resolved 
clinically. For serious infections that remain active for 14 or more days, consider 
discontinuation of magrolimab.
•
After achieving remission, for Grade 4 neutropenia (ANC < 500/µL) with fever or 
infection, and lasting at least 7 days, magrolimab dosing delay should be considered. Upon 
resolution to Grade ≤ 2, resume magrolimab at the same dose should be considered. 
Magrolimab does not need to be dose modified or delayed for Grade 4 thrombocytopenia.
When azacitidine is delayed due to toxicities, magrolimab should continue independently as per 
magrolimab administration schedule (Table 25). Continuous dosing of magrolimab is needed to 
maintain efficacious exposures and prolonged delays of greater than 1 week when magrolimab is 
dosed Q2W have been seen to result in lower clinical efficacy. Magrolimab may be delayed for 
severe neutropenia or serious infection as discussed above; otherwise, magrolimab may be 
delayed if other treatment-emergent and/or related AEs occur, and will require approval by the 
sponsor if the delay is longer than 3 days.
The repriming guidelines presented in Table 6 should be followed for patients with dose delays. 
In case of repriming, assessments should follow magrolimab repriming table (Table 25). 
In the case of repriming, before the administration of the 2 first doses of magrolimab, 
hemoglobin should be ≥ 9 g/dL. Transfusion is allowed to meet this hemoglobin level.


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Table 6.
Repriming Guidelines for Magrolimab
Dose of Magrolimab
Minimum Duration of Treatment Gap That Will
Lead to Repriming
1 mg/kg 
2 weeks
15 mg/kg
2 weeks
30 mg/kg
4 weeks
If planned surgical procedures that are needed for patients on study treatment, magrolimab will 
be delayed and restarted in accordance with Table 7.
Table 7.
Magrolimab Dosing Guidance for Planned Surgical Procedures on 
Study
Planned Surgical Procedure
Magrolimab Dose Guidance
Minimally invasive procedure
(Examples: biopsies [excluding lung/liver], 
skin/subcutaneous lesion removal, 
cataract/glaucoma/eye surgery, cystoscopy)
Hold magrolimab dose 3 days prior to procedure and 
restart after 3 days.
Moderately invasive procedure
(Examples: lung/liver biopsy, hysterectomy, 
cholecystectomy, hip/knee replacement, minor 
laparoscopic procedures, stent/angioplasty)
Hold magrolimab dose 5 days prior to procedure and 
restart after 5 days.
Highly invasive procedure
(Examples: CNS/spine surgery, major vascular surgery, 
cardiothoracic surgery, major laparoscopic surgery)
Hold magrolimab dose 7 days prior to procedure and 
restart after 7 days.
CNS = central nervous system
5.10.1.2.
Azacitidine Treatment Delays
Treatment delay of azacitidine may not occur for patients in the initial 28-day period (Cycle 1).
After the initial 28-day period, in the absence of AML (as defined in Section 5.10.1.3.1.2), if 
hematologic toxicity is observed following azacitidine treatment, the next cycle of treatment 
should be delayed until platelets are ≥ 50  109/L and neutrophils are ≥ 1.0  109/L or if blood 
counts are improving from nadir or baseline. If recovery is achieved within 14 days, no dose 
adjustment is needed. However, if recovery is not achieved within 14 days (Day 42 of the cycle), 
the dose should be reduced according to the azacitidine dose modification guidelines in Table 8. 
For nonhematologic AEs ≥ Grade 3 that do not resolve to ≤ Grade 2 or baseline value, dosing 
will be delayed up to 14 days from onset. If recovery is achieved within 14 days, no dose 
adjustment is needed. However, if recovery is not achieved within 14 days, the dose should be 
reduced according to the azacitidine dose modification guidelines in Table 8. Following dose 
modifications, the cycle duration should return to 28 days. Azacitidine dosing may also be 
delayed for patients who experience hospitalization due to an AE that may preclude safe 
administration of azacitidine (eg, intensive care unit admissions, significant bleeding events, 
severe infections, or other such events).


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If ≤ 2 doses of azacitidine are missed during the 7-day dosing period, dosing should continue so 
that the patient receives the full 7 days of treatment, as long as these additional doses are given 
within 1 week of the previous dose. If ≥ 3 doses of azacitidine are missed during the 7-day 
dosing period, the investigator should contact the sponsor, and a dosing decision should be made 
on an individual case basis.
5.10.1.3.
Azacitidine Dose Modifications Guidance
Dose modification of azacitidine may not occur for patients in the initial 28-day period (Cycle 1).
Dose modifications described below are in accordance with the azacitidine prescribing 
information, with 1 notable exception: while the US prescribing information allows for dose 
escalation to 100 mg/m2 after the first 2 cycles, an azacitidine dose of 75 mg/m2 is planned 
throughout this study for both treatment arms. Azacitidine dose increases above 75 mg/m2 are 
not allowed. 
5.10.1.3.1.
Dose Modification Due to Hematologic Toxicity
5.10.1.3.1.1.
Dose Modifications Due to Hematologic Toxicity in the Presence of AML
Treatment with azacitidine is associated with anemia, neutropenia, and thrombocytopenia. Thus, 
complete blood count (CBC) will be performed as described in the schedules of assessments and 
as needed to monitor toxicity. Importantly, these cytopenias are often a result of underlying 
hematologic disease. It is thus critical to distinguish between cytopenias due to azacitidine 
compared to underlying disease, so as to not limit potential treatment benefit. Hematologic 
cytopenias in the presence of AML disease are not defined as hematologic toxicities.
In accordance with this distinction, the dose of azacitidine should not be reduced if hematologic 
cytopenias are observed in the presence of persistent AML; ie, evidence of the following:
•
≥ 5% blasts in the bone marrow
•
blasts with Auer rods
•
circulating blasts
Nonhematologic toxicities may require dose modifications independent of the presence of 
persistent AML, given the clearer distinction of these toxicities relating to azacitidine as opposed 
to effects of AML. Dose modifications for hematologic toxicity, decreased bone marrow 
cellularity, and nonhematologic toxicities are described in the sections below.
5.10.1.3.1.2.
Dose Modifications Due to Hematologic Toxicity in the Absence of AML
Azacitidine should be dose modified or delayed for hematologic toxicities without evidence of 
persistent AML (defined in Section 5.10.1.3.1).


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If hematologic toxicity is observed following azacitidine treatment, the next cycle of therapy 
should be delayed for up to 14 days until the platelet count and the ANC have improved. 
If recovery is achieved within 14 days, no dose adjustment is necessary. However, if recovery is 
not achieved within 14 days (Day 42 of the cycle), the dose should be reduced according to 
Table 8. Following dose modifications, the cycle duration should return to 28 days. Patients with 
a dose reduction will be reassessed after 2 additional cycles per protocol. For patients with 
persistent cytopenia, treatment should be delayed for up to 14 days (Day 42 of the cycle); if 
counts have recovered, no further dose modification is needed. If counts have not recovered, then 
a further dose reduction is recommended, in accordance with Table 8. The reduced dose should 
be maintained during subsequent cycles unless further toxicity develops (defined in Table 8 as 
further occurrences). Azacitidine may be re-escalated back to a higher dose if toxicities have 
improved.
Separate dose modifications for hematologic toxicity are provided in Table 8 for patients who do 
not have reduced blood counts at baseline (ANC ≥ 1.5  109/L and platelets ≥ 75  109/L) and 
who have reduced baseline blood counts (ANC < 1.5  109/L or platelets < 75  109/L).
Table 8.
Azacitidine Dose Modification for Patients With and Without 
Cytopenia at Baseline
Nadir Counts
ANC (109/L)
Platelets (109/L)
% Dose in the Next Cycle if Recoverya is Not 
Achieved Within 14 Days
Dose Modification for Patients Without Reduced Blood Counts (ANC ≥ 1.5  109/L and Platelets 
≥ 75  109/L) at Baseline
First occurrence
≤ 1.0 or
≤ 50.0
67% (50 mg/m2)
Second occurrenceb
≤ 1.0 or
≤ 50.0
50% (37.5 mg/m2)
Third occurrenceb
≤ 1.0 or
≤ 50.0
33% (25 mg/m2)
Dose Modification for Patients with Reduced Blood Counts (ANC < 1.5  109/L or Platelets < 75  109/L) at 
Baseline
First occurrence
< 0.5c or
< 25c
67% (50 mg/m2)
Second occurrenceb
< 0.5c or
< 25c
50% (37.5 mg/m2)
Third occurrenceb
< 0.5c or
< 25c
33% (25 mg/m2)
ANC = absolute neutrophil count; AML = acute myeloid leukemia.
a
Recovery is defined as a ≥ 25% recovery in the nadir count.
b
After initial dose reduction, patients will be reassessed after 2 additional cycles per protocol, and if persistent cytopenias are 
observed, a further dose reduction of azacitidine should be considered as outlined.
c
No dose adjustment is needed if the baseline blood counts are below an ANC < 0.5  109/L and/or platelets < 25  109/L.


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Following dose modifications, the cycle duration should return to 28 days.
If per dosing modification Table 8, the patient is eligible to start the cycle, but the cycle is 
delayed, investigator should contact the medical monitor. 
The start of the subsequent cycle should not be delayed beyond 2 weeks if the patient’s clinical 
condition allows safe resumption of the cycle. If the start of the subsequent cycle is delayed 
beyond 2 weeks, the investigator should contact the medical monitor. 
5.10.1.3.1.3.
Dose Modifications Due to Decreased Bone Marrow Cellularity in the Absence of 
AML
Azacitidine alone or in combination with magrolimab may result in a decrease in bone marrow 
cellularity. No dose modification is required if a decrease in bone marrow cellularity is observed 
without reduced peripheral blood counts or if persistent AML is still observed (defined in 
Section 5.10.1.3.1.1). If hypocellularity AND reduced peripheral blood counts are observed, then 
the azacitidine dose should be modified in accordance with the instructions in Table 9.


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Table 9.
Azacitidine Dose Modification: Patients With Reduced Bone Marrow 
Cellularity and Reduced Peripheral Blood Counts
Azacitidine Dose Instruction if Recoveryb Is Not Achieved Within 14 Days
Bone Marrow 
Cellularity
First Occurrence
Second Occurrence
Third Occurrence
Recoveryb 
≥ 50% decrease 
from baseline 
with a cellularity 
< 30% in the 
presence of 
reduced 
peripheral blood 
countsa
OR
Decrease to 
< 15% cellularity 
with a baseline 
cellularity > 20% 
in the presence 
of reduced 
peripheral blood 
countsa
Dose reduce 
azacitidine to 
50 mg/m2 
administered 
Days 1–7 per cycle
AND
Repeat bone 
marrow biopsy to 
assess bone 
marrow cellularity 
after 2 cycles
Dose reduce 
azacitidine to 
37.5 mg/m2 
administered 
Days 1-7 per cycle
AND
Repeat bone marrow 
biopsy to assess bone 
marrow cellularity 
after 2 cycles
Dose reduce 
azacitidine to 
25 mg/m2 
administered 
Days 1–7 per cycle
AND
Repeat bone 
marrow biopsy to 
assess bone marrow 
cellularity within 2 
cycles
Upon reassessment 
after 2 cycles, if 
reduced cellularity 
persists, then 
decrease 
azacitidine dose to 
25 mg/m2 on 
Days 1–5 per cycle 
and reassess bone 
marrow cellularity 
after 2 cycles
Continue at current 
azacitidine dose. For 
subsequent cycles, the 
azacitidine dose can be 
escalated up to the next 
highest dose 
(ie, escalate to 
75 mg/m2 if initially 
dose reduced to 
50 mg/m2; escalate to 
50 mg/m2 if previously 
dose reduced to 
37.5 mg/m2; or escalate 
to 37.5 mg/m2 if 
previously dose 
reduced to 25 mg/m2).
AND
Repeat bone marrow 
biopsy to assess bone 
marrow cellularity at 
the next protocol-
defined bone marrow 
assessment.
ANC = absolute neutrophil count; AML = acute myeloid leukemia
a
Reduced peripheral blood counts are defined as ANC < 0.5  109/L and platelets < 25  109/L in the absence of AML 
disease (ie, < 5% bone marrow blasts)
b
Recovery in bone marrow cellularity is defined as an increase in bone marrow cellularity ≥ 25% from the nadir, increase in 
bone marrow cellularity to ≥ 15%, or improvement of peripheral blood counts to ANC > 0.5  109/L and platelets 
> 25  109/L.
Following dose modifications, the cycle duration should return to 28 days.
If per dosing modification Table 9, the patient is eligible to start the cycle, but the cycle is 
delayed, investigator should contact the medical monitor. 
The start of the subsequent cycle should not be delayed beyond 2 weeks if the patient’s clinical 
condition allows safe resumption of the cycle. If the start of the subsequent cycle is delayed 
beyond 2 weeks, the investigator should contact the medical monitor. 


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5.10.1.3.2.
Dose Modifications Due to Nonhematologic Toxicity Irrespective of Presence of 
AML
Renal abnormalities ranging from elevated serum creatinine to renal failure have been reported 
with rare frequency in patients treated with azacitidine. In addition, renal tubular acidosis, 
defined as a decrease in serum bicarbonate to < 20 mmol/L in association with an alkaline urine 
and hypokalemia (serum potassium < 3 mmol/L), has been rarely observed. If unexplained 
reductions in serum bicarbonate (< 20 mmol/L) occur, the azacitidine dose should be reduced 
by 50% on the next cycle. Similarly, if unexplained elevations in serum creatinine or blood urea 
nitrogen to ≥ 2-fold above baseline values and above the ULN occur, the next cycle should be 
delayed until values return to normal or baseline, and the azacitidine dose should be reduced 
by 50%. The reduced dose should be maintained during subsequent cycles unless toxicity 
develops.
For other azacitidine-related nonhematologic toxicities that are ≥ Grade 3 that do not resolve 
to ≤ Grade 2 or baseline levels, azacitidine dosing should be delayed up to 14 days until 
resolution to ≤ Grade 2 or baseline levels. If ≥ Grade 3 toxicities continue despite this dose 
delay, dose modification of azacitidine should be performed in accordance with Table 10.
Following dose modifications, the cycle duration should return to 28 days.
Table 10.
Azacitidine Dose Modification: Nonhematologic Toxicities
Azacitidine Dose Instruction if Recoverya is Not Achieved within 14 Days
Toxicity
First Occurrenceb
Second Occurrenceb
Third Occurrenceb
Grade 3 or higher 
nonhematologic 
adverse event
Dose reduce azacitidine 
to 50 mg/m2 
administered Days 1–7 
per cycle
AND
Reassess toxicity on 
subsequent cycle; if still 
persistent despite dose 
delay, proceed to 
second occurrence.
Dose reduce azacitidine 
to 37.5 mg/m2 
administered Days 1–7 
per cycle
AND
Reassess toxicity on 
subsequent cycle; if still 
persistent despite dose 
delay, proceed to third 
occurrence.
Dose reduce azacitidine to 
25 mg/m2 administered Days 1–7 
per cycle
AND
Reassess toxicity on subsequent 
cycle; if still persistent despite dose 
delay, then administer azacitidine at 
25 mg/m2 on Days 1–5 per cycle. 
Reassess toxicity on subsequent 
cycle. 
Fourth occurrence and beyond: If 
toxicity still persists, then contact 
the medical monitor for azacitidine 
dosing instructions.
a
Recovery is defined as improvement of nonhematologic toxicity to ≤ Grade 2 or baseline value within 14 days of dose 
delay.
b
Azacitidine may be dose-escalated back to the original dose or next higher dose level if there is resolution of the toxicity to 
≤ Grade 2 or back to baseline level.


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5.10.2.
Venetoclax + Azacitidine (Control Arm for Patients Appropriate for 
Non-intensive Treatment)
Patients treated with venetoclax may develop tumor lysis syndrome. Assess blood chemistry 
(potassium, uric acid, phosphorous, calcium, and creatinine) and correct preexisting 
abnormalities prior to initiation of treatment with venetoclax. Blood chemistry must be 
monitored for tumor lysis syndrome at predose, 6 to 8 hours after each new dose during ramp-up 
(Days 1, 2, 3), and 24 hours after reaching maintenance dose. Dose modifications and delays for 
venetoclax due to AEs should follow Table 11 or the venetoclax prescribing information.
The treatment with venetoclax + azacitidine will be administered as inpatient/outpatient based on 
local guidelines for treatment of non-intensive treatment/investigator assessment of the patient’s 
clinical status.
At the start of each cycle, both venetoclax and azacitidine are administered on the same day.
5.10.2.1.
Dose Modifications and Treatment Delays
Table 11.
Dose Modifications and Delays for Venetoclax Due to Adverse Events
Event
Occurrence
Action Taken
Hematologic toxicities
Occurrence prior to 
achieving remissiona
In most instances, do not interrupt venetoclax and 
azacitidine due to cytopenias prior to achieving remission. 
First occurrence after 
achieving remissiona 
and lasting at least 
7 days
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Upon resolution to 
Grade 1 or 2, resume venetoclax therapy at the same dose 
in combination with azacitidine.
Grade 4 neutropenia 
with or without fever or 
infection; or Grade 4 
thrombocytopenia
Subsequent occurrences 
in cycles after 
achieving remissiona 
and lasting 7 days or 
longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Upon resolution to 
Grade 1 or 2, resume venetoclax therapy at the same dose 
and reduce the duration by 7 days for each subsequent 
cycle.
a.
Bone marrow assessment to be performed as per Table 21 and results reviewed to know the remission status needed for the 
dosing modifications per this table.
5.10.3.
7 + 3 (or 5 + 2) Chemotherapy (Control Arm for Patients Appropriate for 
Intensive Treatment)
There will be no dose delays permitted for cytarabine, daunorubicin, or idarubicin. If deemed 
clinically necessary to reduce cytarabine, daunorubicin, and/or idarubicin doses (eg, 
hyperbilirubinemia, neurotoxicity), please contact the medical monitor.


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5.11.
Prior and Concomitant Medications
5.11.1.
Permitted Concomitant Medications
Premedication, and prophylaxis for AEs as described in Section 5.9, is permitted while on study 
treatment. Localized non-CNS radiotherapy, erythroid and/or myeloid growth factors, hormonal 
therapy with LHRH agonists for prostate cancer, hormonal maintenance therapy for breast 
cancers, and treatment with bisphosphonates receptor activator of nuclear factor kappa-B ligand 
(RANKL) inhibitors are permitted. Red blood cell and platelet transfusions are permitted during 
screening and prior to randomization to ensure adequate hemoglobin level and as per investigator 
clinical judgment. Blood transfusions are also permitted during the study as clinically indicated 
for management of cytopenias and should be recorded in the electronic case report form (eCRF) 
dedicated to on study transfusions. Hydroxyurea and/or leukapheresis can be used throughout the 
study to reduce the WBC to ≤ 20  103/µL. In nonclinical studies, coadministration of 
magrolimab and hydroxyurea in human leukemia engrafted immunodeficient mice did not cause 
phagocytosis of normal bone marrow cells, suggesting limited on-mechanism toxicity in patients. 
No gross safety abnormalities were observed in these nonclinical studies. While no formal 
analyses have been performed, in clinical studies, no significant safety concerns have been 
observed in patients who have received concomitant magrolimab and hydroxyurea or 
magrolimab, azacitidine, and hydroxyurea.
All concomitant medications, including all prescription, over-the-counter, herbal supplements, 
and IV medications and fluids received within 30 days before the first dose of study treatment 
through the 70-day safety follow-up call/visit should be recorded in the eCRF.
5.11.2.
Prohibited Concomitant Medications
Antileukemic therapies including chemotherapy (with the exception of hydroxyurea), targeted 
therapies, and immunotherapy are not permitted while patients are on study treatment.
Live vaccines are prohibited during the study, and for 3 months after the last dose of study 
treatment {Rubin 2014}.
Drugs with cardiotoxic potential are prohibited because of the potential cardiotoxicity with the 
use daunorubicin, idarubicin, and azacitidine.
For patients randomized to receive venetoclax and azacitidine, avoid concomitant use of 
venetoclax with strong CYP3A inducers or moderate CYP3A inducers, as use with a strong 
CYP3A inducer decreases venetoclax Cmax which may decrease venetoclax efficacy. 
Preparations containing St John's wort are not allowed during study treatment.
Any investigational drugs other than magrolimab are prohibited during study treatment.
Conversely, concomitant use of strong and moderate CYP3A inhibitors with venetoclax increase 
exposure of venetoclax and therefore may increase the risk of venetoclax related toxicity 
including tumor lysis syndrome. Table 12 describes venetoclax dose modification based on 
concomitant use of strong or moderate CYP3A inhibitor or P-gp inhibitor at initiation, during or 


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after the ramp-up phase. Resume the venetoclax dosage that was used prior to concomitant use of 
a strong or moderate CYP3A inhibitor or P-gp inhibitor 2 to 3 days after discontinuation of the 
inhibitor. Avoid grapefruit products, Seville oranges, and starfruit during treatment with 
venetoclax, as they contain inhibitors of CYP3A.
For additional information drug interactions with venetoclax refer to the local prescribing 
information.
Table 12.
Management of Potential Venetoclax Interactions with CYP3A and 
P-gp Inhibitors
Coadministered Drug
Initiation and Ramp-up 
Phase
Steady Daily Dose (After Ramp-up Phase)
Posaconazole
Day 1 – 10 mg 
Day 2 – 20 mg 
Day 3 – 50 mg 
Day 4 – 70 mg
Reduce venetoclax dose to 70 mg.
Other strong CYP3A inhibitor 
Day 1 – 10 mg 
Day 2 – 20 mg 
Day 3 – 50 mg 
Day 4 – 100 mg
Reduce venetoclax dose to 100 mg
Moderate CYP3A inhibitor 
P-gp inhibitor
Reduce the venetoclax dose by at least 50%
CYP = cytochrome P450 enzyme; P-gp = P-glycoprotein
5.11.3.
COVID-19 Vaccine
There is no contraindication to the COVID-19 vaccine with magrolimab. Given that 
immunocompromised individuals on myelosuppressive treatment may have attenuated responses 
to vaccines, investigators should, after consultation with local guidelines, consider delay of 
COVID-19 vaccination until recovery of a neutropenic individual’s ANC and determine the ideal 
timing of the subsequent dose of vaccine based on count recovery. Investigators should 
document vaccinations. Investigators should notify patients of the risks of delaying the 
COVID-19 vaccination and document this along with any mitigation strategies for preventing 
COVID-19 infection.
5.12.
Accountability for Investigational Medicinal Product
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug (kits, vials, etc). This includes acknowledgment of receipt of each shipment of study drug 
(quantity and condition). All used and unused study drug dispensed to patients must be returned 
to the site.


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Each study site must keep accountability records that capture:
•
The date received and quantity of study drug kits (kits, vials, etc)
•
The date, patient number, and the study lot number dispensed
•
The date, quantity of used and unused study drug returned, along with the initials of the 
person recording the information
Patients should be reminded to bring the venetoclax dosing diary card, all used and unused study 
drug, along with the packaging, to each study visit for review by site staff.
5.12.1.
Investigational Medicinal Product Return or Disposal
Gilead recommends that used and unused study drug supplies be destroyed at the site. If the site 
has an appropriate standard operating procedure (SOP) for drug destruction as determined by 
Gilead, the site may destroy used (empty or partially empty) and unused study drug supplies in 
accordance with that site’s approved SOP. A copy of the site’s approved SOP will be obtained 
for the electronic trial master file. If study drug is destroyed at the site, the investigator must 
maintain accurate records for all study drugs destroyed. Records must show the identification 
and quantity of each unit destroyed, the method of destruction, and the person who disposed of 
the study drug. Upon study completion, copies of the study drug accountability records must be 
filed at the site. Another copy will be returned to Gilead.
If the site does not have an appropriate SOP for drug destruction, used and unused study drug 
supplies are to be sent to the designated disposal facility for destruction. The study monitor will 
provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic intervals.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each patient enrolled in the study are presented in 
tabular form in Appendix 2 (Table 20, Table 21, Table 22, Table 23, Table 24, Table 28 and 
Table 29), and described in the text that follows.
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the contract research organization.
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment onto the study. In order to manage the total 
study enrollment, Gilead, at its sole discretion, may suspend screening and/or enrollment at any 
site or study-wide at any time.
6.2.
Pretreatment Assessments
6.2.1.
Prescreening Visit
In order to minimize impact of screening procedures to patients, an optional prescreening 
consent form will be offered to patients at the investigator’s discretion in order to conduct bone 
marrow biopsy and aspirate to assess TP53 mutational status and for blast evaluation, correlative 
studies, and cytogenetics. Once a patient’s TP53 mutational status has been confirmed, the 
patient will then be offered the full consent form for the study after which screening procedures 
will be completed.
6.2.2.
Screening Visit
Patients will be screened within 30 days after signing of the main informed consent, prior to 
randomization to determine eligibility for participation in the study. The following will be 
performed and documented at screening as per Table 20:
•
Obtain written informed consent. 
•
Central testing of TP53 mutational status (if not performed during prescreening, refer to the 
laboratory manual for details) from a bone marrow aspirate sample. If local TP53 testing 
performed on a bone marrow aspirate sample from an approved local laboratory is available, 
patients can be enrolled following a central review of the local test results without waiting for 
the confirmation of the mutation from central testing.
•
Obtain medical and cancer history (including demographic information, AML molecular 
marker results at diagnosis, and echocardiogram/multigated acquisition [scan] [MUGA] or 
pulmonary function tests if done within the 3 months prior to signing the informed consent 
form [ICF])


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•
Serum pregnancy test (screening pregnancy test may be used as Cycle 1 Day 1 test if 
performed within 72 hours prior to administration of the first dose)
•
Complete physical examination including vital signs, body weight, and height
•
CBC with differential, platelets, reticulocytes, blasts
•
Serum or plasma chemistry
•
Prothrombin time (PT), international normalized ratio (INR), and activated partial 
thromboplastin time (aPTT) or PTT
•
Red blood cell ABO/Rh type and screen (any of the 4 blood groups A, B, AB, and O 
comprising the ABO system [ABO]/rhesus factor [Rh]), direct antiglobulin test (DAT) and 
RBC extended phenotyping or genotyping. Refer to Section 6.4.4 for more information. 
•
Urinalysis
•
Peripheral blood for MRD assessment
•
Bone marrow biopsy and aspirate for blast evaluation, correlative studies, cytogenetics, and 
MRD assessment (not required if the patient was prescreened)
•
Peripheral blood smear (for blasts)
•
HBV, HCV, and HIV
•
ECOG performance status (Appendix 10)
•
Perform 12-lead electrocardiogram (ECG) (single)
•
Echocardiogram or MUGA (for patients appropriate for intensive therapy)
•
Record all SAEs and any AEs related to protocol-mandated procedures occurring after 
signing of the ICF
•
Record prior and concomitant medications
•
Eligibility criteria
From the time of obtaining informed consent through the first administration of study drug, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the AEs eCRF. 
All other untoward medical occurrences observed during the screening period, including 
exacerbation or changes in medical history are to be considered medical history. See Section 7 
Adverse Events and Toxicity Management for additional details.
6.3.
Randomization
Randomization procedures are described in Section 5.1.1


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6.4.
On Study-Treatment Assessments
6.4.1.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential. Note that a 
woman is considered to be of childbearing potential (ie, fertile) following menarche and until 
becoming postmenopausal unless permanently sterile. Permanent sterilization methods include 
hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. A high follicle-stimulating 
hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal 
state in women not using hormonal contraception or hormonal replacement therapy. However, in 
the absence of ≥ 12 months of amenorrhea, a single FSH measurement is insufficient. A negative 
serum pregnancy test is required at screening, and a negative pregnancy test is required prior to 
study treatment administration on Cycle 1 Day 1. The Cycle 1 Day 1 pregnancy test does not 
need to be repeated if the screening pregnancy test was performed within the 72 hours prior to 
study treatment administration. Serum or urine pregnancy tests will also be required at Day 1 of 
each subsequent cycle. For further details, refer to Appendix 5.
6.4.2.
Complete Blood Counts
Samples for CBCs should be collected per the schedules of assessments in Appendix 2. White 
blood cell count needs to be ≤ 20  103/µL prior to randomization and prior to each magrolimab 
dose for the first 4 weeks (see Section 4.2, Inclusion Criterion 2 for details). Additional samples 
for CBC may be collected outside of the protocol-specified time points to ensure WBC level 
≤ 20  103/µL for the first 4 weeks and repriming/reescalation cycle. Hemoglobin must be 
checked again 3 to 6 hours after the initiation of the first and second doses of magrolimab during 
initial treatment. The patient should be transfused as clinically appropriate. Investigators should 
consider additional hemoglobin monitoring during the first week of treatment in patients with 
symptoms of anemia or at increased risk for complications of anemia.
6.4.3.
Peripheral Blood Smear Assessment
Peripheral blood smears should be collected per the schedules of assessments and assessed for 
standard general cell morphology (first 4 weeks and in case of repriming) and for blast (along 
with bone marrow assessment). These samples should be collected from the arm contralateral to 
the arm being used for drug infusion/injection, if possible. All other observed findings should be 
reported according to local laboratory hematopathology standard procedures. Peripheral blood 
smears will be assessed locally.
In the event the study meets futility, and the sponsor decides to terminate the study, peripheral 
blood smears will no longer be required. Peripheral blood smear assessment may be performed 
per institutional SOC.


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6.4.4.
Type and Screen and Direct Antiglobulin Test
Magrolimab may interfere with RBC phenotyping due to expected coating of the RBC 
membrane. Due to the risk of developing anemia, and because magrolimab may make 
phenotyping difficult due to expected coating of the RBC membrane, ABO/Rh type, antibody 
screen, blood phenotyping or genotyping, and DAT need to be performed at screening before 
exposure to magrolimab, as described in Section 7.8.1.
RBC phenotyping/genotyping, ABO type and DAT need not be repeated if results dated before 
screening are available. Antibody screen need not be repeated if results dated before screening 
are available, unless the patient was transfused since that time.
6.4.5.
Vital Signs
Vital signs will include heart rate, respiratory rate, oxygen saturation, blood pressure, 
temperature, and weight. Height should be recorded during screening only. Weight should be 
recorded during screening and on Day 1 of each cycle. Vital signs are to be recorded prior to 
dosing with study treatment at the visits specified in the schedules of assessments in Table 21, 
Table 22, and Table 23. 
6.4.6.
Physical Examination
Complete physical examination will be performed at screening. Thereafter, symptom-directed 
physical examinations are acceptable and may also include routine examination of the skin 
(including fingers, toes, and ears) and neurologic system. 
6.4.7.
Electrocardiograms
A single 12-lead ECG will be performed at screening for all patients.
For patients undergoing treatment with 7 + 3 intensive chemotherapy, 12-lead ECGs will also be 
performed at the end of Consolidation Cycles 1 and 4, at the EOT visit, and approximately every 
12 weeks during long-term follow-up, as per Table 23 and Table 24.
In the event the study meets futility, and the sponsor decides to terminate the study, ECGs will 
no longer be required. ECG evaluation may be performed per institutional SOC.
6.4.8.
Echocardiogram or MUGA
An echocardiogram or MUGA will be performed at screening for patients appropriate for 
intensive therapy for determination of LVEF.
For patients undergoing treatment with 7 + 3 intensive chemotherapy, an echocardiogram or 
MUGA will also be performed at the end of Consolidation Cycles 1 and 4, at the EOT visit, and 
approximately every 12 weeks during long-term follow-up, as per Table 23 and Table 24.
In the event the study meets futility, and the sponsor decides to terminate the study, 
echocardiograms and MUGAs will no longer be required. Evaluations may be performed per 
institutional SOC.


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6.4.9.
Bone Marrow Assessments
Bone marrow assessments (including aspirate ± core/trephine biopsy) are required for response 
assessments (eg, blast evaluation) (refer to Section 6.6, Table 21, and Table 23), including 
conventional cytogenetic analysis per institutional standards. In addition, bone marrow 
specimens may be used for correlative studies, MRD monitoring, 
, and 
biobanking. Minimal residual disease testing will be performed by a central laboratory. Details 
for preparation and distribution of aspirate and biopsy/trephine specimens to the testing 
laboratories will be provided in the laboratory manual for this study.
In the event the study meets futility, and the sponsor decides to terminate the study, bone marrow 
assessments may continue locally as per the schedule outlined in Table 13 and Appendix 2 
Table 26, Table 27, and Table 28 or as per investigator discretion. MRD testing will not be 
required nor performed by the central laboratory but may be done locally per SOC. Cytogenetic 
testing may be performed locally per SOC but will not be required.
Bone marrow assessments include collection of both aspirate ± core biopsy (trephine) specimens 
at each time point according to the schedules of assessments in Appendix 2 and as summarized 
in Table 13.
Table 13.
Timing of Response Assessments
Response Assessment 
from: 
Bone Marrow, 
Aspirate/Biopsies, and 
Peripheral Blood Smear 
(for Blasts)a
Experimental Arm: 
Magrolimab + 
Azacitidine 
Control Arm: 
Venetoclax + Azacitidine
Control Arm: 7 + 3 
Chemotherapy Regimen
At Screening
Prior to first dose of study 
treatment
Prior to first dose of study 
treatment
Prior to first dose of study 
treatment
D28 bone marrow can be performed on D1 of the 
subsequent cycle if the delay of starting the subsequent 
cycle is not foreseen to be more than 7 days. 
Results of bone marrow assessment to be reviewed to 
determine the timing of subsequent cycles and schedule 
modifications as recommended in Table 8 and Table 9 
for the magrolimab + azacitidine arm, and Table 11 for 
the venetoclax +azacitidine arm.
C1D28 (± 7 days)
C1D28 (± 7 days)
Cycle 1 Day 15 (± 5 days) 
(after 7 + 3 only; to 
determine if a new 
induction cycle of 5 + 2 is 
needed); and 
During Study Treatment
C2D28 (± 7 days)
C2D28 (± 7 days)
At count recovery 
following induction or 
Day 42 after the start of 
the most recent induction 
treatment, whichever is 
earlier; and 
CCI


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Response Assessment 
from: 
Bone Marrow, 
Aspirate/Biopsies, and 
Peripheral Blood Smear 
(for Blasts)a
Experimental Arm: 
Magrolimab + 
Azacitidine 
Control Arm: 
Venetoclax + Azacitidine
Control Arm: 7 + 3 
Chemotherapy Regimen
C4D28 (± 14 days)
C4D28 (± 14 days)
C6D28 (± 14 days)
C6D28 (± 14 days)
and every 3 cycles (± 14 
days) thereafter
and every 3 cycles (± 14 
days) thereafter
If therapy is stopped at 
Consolidation Cycle 1, 
then at count recovery 
after Cycle 1 or not later 
than Day 42 after the start 
of Consolidation Cycle 1, 
whichever is earlier,
or
If therapy is stopped at 
Consolidation Cycle 2, 
then at count recovery 
after Cycle 2 or not later 
than Day 42 after the start 
of Cycle 2, whichever is 
earlier, 
or
If therapy is stopped at 
Consolidation Cycle 3, 
then at count recovery 
after Cycles 2 and 3 or not 
later than Day 42 after the 
start of each Cycle 2 and 
Cycle 3, whichever is 
earliest for each cycle, 
or
If therapy is stopped at 
Consolidation Cycle 4, 
then at count recovery 
after Cycles 2 and 4 or not 
later than Day 42 after the 
start of each Cycle 2 and 
Cycle 4, whichever is 
earliest for each cycle.
End of Treatment (EOT)
Last Dose or EOT (± 14 days),
if not performed within the last 30 days
Long-term Follow-up 
Every 12 weeks thereafter (± 14 days), from last CXD1
Post SCT 
Every 12 weeks thereafter, from SCT Day 1
C = Cycle; D = Day; SCT = stem cell transplant
a.
Bone marrow biopsies will be collected at screening and Day 28 of Cycles 2 and 6.
For the experimental arm magrolimab + azacitidine and control arm venetoclax + azacitidine, the 
Day 28 bone marrow assessment may be performed on Day 1 of the subsequent cycle if the 
delay of starting the subsequent cycle is not foreseen to be more than 7 days.


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A response assessment at the EOT visit is not required if it has been performed within the last 
30 days, if progressive disease has been documented, or if patient continues on long-term follow-
up. Bone marrow aspirate and response assessments should continue during long-term follow-up 
approximately every 12 weeks until progressive disease is documented or until start of a new 
anti-AML therapy. In the event the study meets futility, and the sponsor decides to terminate the 
study, bone marrow assessments at EOT and during long-term follow-up is not required.
For patients who come off the study treatment to receive an SCT, follow-up for response 
assessment and collection of bone marrow biopsy/aspirate results will continue every 12 weeks, 
until documented disease progression or relapse occurs. In the event the study meets futility, and 
the sponsor decides to terminate the study, bone marrow assessments for patients undergoing 
SCT is not required.
6.4.10.
Patient-reported Outcomes
Four patient-reported outcome (PRO) instruments will be administered in this study: the EORTC 
QLQ-C30, the EQ-5D-5L, the PGIS, and the PGIC. The patient should complete these 
questionnaires before any other study procedures at required visits. Please refer to schedule of 
assessments (Table 21, and Table 23) for timing of PRO assessments.
In the event the study meets futility, and the sponsor decides to terminate the study, PRO 
assessments will no longer be required.
6.4.10.1.
EORTC QLQ-C30
The EORTC QLQ-C30 is a reliable and valid measure of PRO and has been widely used among 
cancer patients. The EORTC QLQ-C30 includes 30 separate questions (items) resulting in 
5 functional scales (physical functioning, role functioning, emotional functioning, cognitive 
functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, 
nausea and vomiting, and pain) and 6 single items (dyspnea, insomnia, loss of appetite, 
constipation, diarrhea, and financial difficulties) {Fayers 2001}. The recall period is 1 week (past 
week). It will require approximately 11 minutes to complete. An example is provided in 
Appendix 7.
6.4.10.2.
EQ-5D-5L
The EQ-5D-5L is an instrument for use as a measure of health outcome {EuroQol Research 
Foundation 2017, Janssen 2013}. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive 
system and the EQ visual analogue scale (EQ VAS). An example is provided in Appendix 8.
The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems, and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for 
that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that 
describes the patient’s health state.


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The EQ VAS records the patient’s self-rated health on a vertical VAS, where the endpoints are 
labeled “the best health you can imagine” and “the worst health you can imagine.” The EQ VAS 
can be used as a quantitative measure of health outcome that reflects the patient’s own judgment.
6.4.10.3.
PGIS/PGIC
The PGIS and PGIC assessments are both single-item assessments used to demonstrate 
sensitivity and meaningful change thresholds and bolster the validity of selected PRO 
assessments {Department for Health and Human Services (DHHS) 2018}. These questionnaires 
are provided in Appendix 9. In the event the study meets futility, and the sponsor decides to 
terminate the study, PGIS and PGIC assessments are not required to be used in determining the 
thresholds but will be analyzed descriptively. 
6.4.11.
Adverse Events
At each visit, all AEs observed by the investigator or reported by the patient that occur after the 
first dose of study treatment through 70 days after the last dose of study treatment are to be 
reported using the applicable eCRF (Section 7.1.1). Full details on the definitions, assessment 
and reporting instructions for AEs are provided in Section 7.
In the event the study meets futility, and the sponsor decides to terminate the study, AEs that 
occur following initiation of study medication, regardless of cause or relationship, will be 
collected until 30 days (± 7 days) after last administration of study drug and reported on the 
eCRFs as instructed. 
6.4.12.
Concomitant Medications
All concomitant medications taken by the patient while on study are to be documented. Changes 
in baseline concomitant medication information is to be collected after informed consent through 
the study treatment period, and up until 70 days after treatment discontinuation. Concomitant 
medication associated with procedure-related AEs will be captured from the time of informed 
consent and onward. Information to be collected includes therapy name, indication, route, start 
date, and stop date and must be reported using the applicable eCRF. Note that any anti-AML 
therapies after the study treatment period should also be collected per the schedule of 
assessments (Table 24). 
In the event the study meets futility, and the sponsor decides to terminate the study, concomitant 
medications will be collected until 30 days (± 7 days) after last administration of study drug and 
reported on the eCRFs as instructed. Post-study anti-AML therapy status will not be collected for 
patients discontinuing study treatment in the event of study termination due to futility.
6.5.
Safety Assessments
Analytes to be assessed by the local laboratory or specialty laboratories at screening are 
presented in Table 14. See Appendix 10 for ECOG assessment information.


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Table 14.
Laboratory Analyte Listing (to be Performed at Screening)
Chemistry
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory 
Measurements
Sodium
Potassium
Chloride
Bicarbonatea
Total protein
Albumin
Calcium
Magnesium
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
Haptoglobin
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Hematocrit
Platelets
WBC differential
Absolute neutrophil 
count (ANC)
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
Blasts
Peripheral blood 
smear: 
Blasts (with bone 
marrow assessments)
Coagulation:
PT
INR
aPTT or PTT
RBC
Protein
Serum pregnancy
Blood phenotyping or 
genotypingb
Type and screen (ABO/Rh), 
DAT
HIV antibody
Hepatitis B and hepatitis C 
assessments: 
HBsAg, anti-HBc, HCV 
antibody, HBV DNA, and 
HCV RNA, as applicable
Bone marrow aspirate and 
biopsy:
Blast evaluation
Correlative studiesc
Cytogenetics
MRDc
Peripheral blood:
MRDc
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ALT = alanine aminotransferase; 
anti-HBc = hepatitis B core antibody; aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; 
BUN = blood urea nitrogen; DAT = direct antiglobulin test; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; 
HCV = hepatitis C virus; HIV = human immunodeficiency virus; INR = international normalized ratio; LDH = lactate 
dehydrogenase; MRD = minimal residual disease; PT = prothrombin time; PTT = partial thromboplastin time; RBC = red blood 
cell; Rh = rhesus factor; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; 
WBC = white blood cells.
Note: Refer to Appendix 2 for collection time points.
a 
If available at the local laboratory.
b
Genotyping can be performed locally or centrally.
c
These assays will be performed at a central laboratory. MRD assessment will not be required if the patient was prescreened. 
Analytes to be assessed by the local laboratory or specialty laboratories during the study are 
presented in Table 15.


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Table 15.
Laboratory Analyte Listing (to be Performed During the Study)
Chemistry
(Serum or Plasma)
Hematology
Other Laboratory Measurements
Sodium
Potassium
Calcium
Chloride
Bicarbonatea
Albumin
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
Haptoglobin
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Platelets
WBC differential
Absolute neutrophils count (ANC)
Lymphocytes
Reticulocytes
Blasts
Peripheral blood smeard:
General morphology 
Experimental Arm or Venetoclax + 
Azacitidine: 
C1D1, C1D2, C1D11 only
7 + 3 chemotherapy: 
C1D1, C1D2, C1D15 only
Blasts (with bone marrow 
assessments)
Serum or urine pregnancy
Pharmacokinetics’
Antidrug antibodiesb
Bone marrow aspirate and 
biopsy:
Blast evaluation
Correlative studiesb
Cytogeneticsc
MRDb
Peripheral blood:
Correlative studiesb
MRDb
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; ALT = alanine aminotransferase; 
AST = aspartate aminotransferase; BUN = blood urea nitrogen; C = cycle; D = day; DAT = direct antiglobulin test; 
LDH = lactate dehydrogenase; MRD = minimal residual disease; RBC = red blood cell; Rh = rhesus factor; SGOT = serum 
glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; SOC = standard of care; WBC = white blood 
cell.
Note: Refer to Appendix 2 for collection time points.
a 
If available at the local laboratory.
b
These assays will be performed at a central laboratory. In the event the study meets futility, and the sponsor decides to 
terminate the study, MRD assessments and correlative studies will no longer be required; MRD assessments may be 
performed locally per SOC for patients remaining on study treatment.
c
In the event the study meets futility, and the sponsor decides to terminate the study, cytogenetics will no longer be required; 
it may be performed locally per SOC for patients remaining on study.
d
In the event the study meets futility, and the sponsor decides to terminate the study, peripheral blood smears will no longer 
be required.
6.6.
Efficacy Assessments
Clinical response will be assessed using the guidelines in Appendix 6 which are based primarily 
on ELN AML recommendation and IWG AML response criteria {Cheson 2003, Dohner 2017} 
with modifications.
Response assessments will be performed in conjunction with bone marrow assessments, 
according to the schedule of assessments (Table 21 and Table 23). The timing of these 
assessments is also summarized in Table 13. Accompanying laboratory results ± 2 weeks from 
the protocol-specified bone marrow efficacy assessment can be used to support an efficacy 
assessment, but peripheral blood smears for blasts should be done on the day of the bone marrow 


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assessments. Response assessments for magrolimab + azacitidine and venetoclax + azacitidine 
are scheduled at Cycle 1 Day 28, Cycle 2 Day 28, Cycle 4 Day 28, Cycle 6 Day 28, and then at 
the end of every 3 cycles thereafter during study treatment. For patients who receive control 
treatment with 7 + 3 (5 + 2) chemotherapy, response assessments will be performed as 
summarized in the schedule of assessments and Table 13. These supporting laboratory results 
will be entered into the eCRF. If a patient achieves a CR, subsequent bone marrow assessments 
are still required to be performed as per the schedule of assessments and Table 13.
Response assessment will be obtained at the EOT visit, unless a prior response assessment has 
been performed within the last 30 days or progressive disease has been documented, or if patient 
continues on long-term follow-up. Response assessments should continue during long-term 
follow-up approximately every 12 weeks until progressive disease is documented or start of a 
new anti-AML therapy. For patients who come off the study treatment to receive an SCT, 
follow-up for response assessment and collection of bone marrow biopsy/aspirate results will 
continue every 12 weeks from the date of SCT, until documented disease progression or relapse 
or initiation of new anti-AML therapy (excluding maintenance therapy) occurs.
In the event the study meets futility, and the sponsor decides to terminate the study, response 
assessments may continue locally as per the schedule outlined in Table 13, Table 26, or Table 28 
or as per investigator discretion.
6.7.
Pharmacokinetics
Pharmacokinetic samples will be evaluated for magrolimab concentrations. Serum magrolimab 
assessment will be done using a validated assay.
Pharmacokinetic samples will be collected as described per schedule of assessments (Table 21 
and Table 22).
In the event the study meets futility, and the sponsor decides to terminate the study, 
pharmacokinetic samples will no longer be collected.
6.8.
Immunogenicity (Antidrug Antibodies)
Peripheral blood for immunogenicity assessments for ADA against magrolimab will be collected 
as described per schedule of assessments (Table 21 and Table 22). When collected on the day of 
study treatment dosing, the blood sample must be collected at the same time as the predose PK 
specimen. Neutralizing antibodies to magrolimab will also be assessed in samples that test 
positive for ADA.
In the event the study meets futility, and the sponsor decides to terminate the study, 
immunogenicity (ADA) samples will no longer be collected.


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6.9.
Pharmacodynamics and Biomarker Assessments
6.9.1.
Correlative Blood Samples
Correlative studies will be performed on peripheral blood samples to study the biological activity 
of the treatment. These studies may include, but are not limited to, investigations of plasma 
cytokine levels, characterization of circulating immune cells, and other studies. Samples for 
correlative studies in the peripheral blood will be collected per schedule of assessments 
(Table 21 and Table 23).
In the event the study meets futility, and the sponsor decides to terminate the study, correlative 
blood samples will no longer be collected.
6.9.1.1.
Measurement of Plasma Cytokines
Cytokine release by immune cells is one surrogate measure of immune cell activation (including 
T-cells and macrophages). Since magrolimab activates both macrophages and T-cells, it is 
hypothesized that a specific cytokine profile relating to immune cell activation will correlate 
with clinical response to therapy. Fluorescence-based platforms allow for a high-throughput 
analysis of a multitude of cytokines and chemokines with high sensitivity {Swartzman 1999}. A 
predefined multiplex panel of human cytokines will be measured from a small, thawed vial of 
plasma, detecting and quantifying the soluble proteins and peptides that help control cellular 
function. The observed systemic biochemical changes in the blood may provide a further 
correlate with tumor progression and therapeutic response and help provide a much broader 
understanding of disease. Cytokines involved in macrophage, dendritic cell, and T-cell 
activation/repression will be specifically interrogated.
6.9.1.2.
Characterization of Circulating Immune Cells
In nonclinical studies, macrophage-mediated phagocytosis of tumor cells by an anti-CD47 
antibody leads to cross-presentation of antigens and subsequent T-cell activation {Tseng 2013}. 
It is therefore predicted that magrolimab administration may lead to T-cell activation in patients. 
Peripheral blood samples will be collected, and T-cell activation/repression markers/studies may 
be performed by flow cytometry, mass cytometry, in vitro T-cell activation assays, and/or T-cell 
receptor sequencing. Additional peripheral blood mononuclear cells and plasma at the specified 
time points will also be cryopreserved and biobanked for future analyses.
6.9.2.
Minimal Residual Disease Monitoring
Minimal residual disease monitoring has become a powerful prognostic factor that is beginning 
to play a central role in the treatment of patients with MDS and AML both in the pretransplant 
and post-transplant settings. In multiple large studies of previously untreated patients with MDS 
and AML, as well as in advanced MDS patients who achieved CR, MRD positivity post-therapy 
was an independent poor prognostic factor and a predictor of relapse {Buccisano 2012, Freeman 
2013, Platzbecker 2018, Sievers 2003}. In a large prospective study of MRD monitoring in both 
MDS and AML patients who achieved CR and received post-remission azacitidine, the 12-month 


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relapse-free survival for those who were MRD positive was 46% compared to 88% in patients 
who were MRD negative. Several methods for MRD monitoring have been utilized in AML 
including: 1) multiparameter flow cytometiy for detection of abe1rnnt hematopoietic surface 
antigens, 2) molecular monitoring of leukeinia-specific mutational burden, and 3) cytogenetic 
monitoring of leukeinia-associated chromosomal abnonnalities. 
~
ytometiy will be utilized as the main method of MRD analysis and, _ 
-
may be compared to NGS or cytogenetic approaches to MRD monitoring. 
Minimal residual disease testing will be perfo1med by a central laborato1y, and inc01porated for 
response assessments, where appropriate. 
Minimal residual disease assessments in the bone manow will be collected at the same time as 
the bone manow efficacy response assessments, as outlined in schedule of assessments (Table 21 
and Table 23) and Table 13. 
In the event the study meets futility, and the sponsor decides to te1minate the study, MRD 
samples will no longer be collected; MRD assessment may be perfo1med locally per SOC for 
patients remaining on study ti·eatinent. 
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6.9.4. 
Post-treatment Assessments 
Final 
Amendment5 
Post-ti·eatment assessments can be found in Table 24. In the event the study meets futility, and 
the sponsor decides to terminate the study, post-h'eatment assessments can be found in Table 28. 
6.10. 
Assessments for Early Discontinuation from Study 
If a patient discontinues study dosing (for example, as a result of an AE), eve1y attempt should 
be made to keep the patient in the study and continue to perfo1m the required study-related 
follow-up and procedures (Section 6.10.1 ). If this is not possible or acceptable to the patient or 
investigator, the patient may be withdrawn from the study. For patients who discontinue from the 
study prior to completion of all protocol-required visits for study assessments or survival 
follow-up as described in the schedule of assessments (Table 24), the investigator may search 
publicly available records (where pennitted by local laws and regulations) to ascertain survival 
status. This ensures reduced risk of missing critical efficacy data. 
In the event the study meets futility, and the sponsor decides to te1minate the study, all patients 
who discontinue study ti·eatment for any reason will not be followed for smvival; patients should 
have an EOT visit (within 7 days after last dose or EOT decision, whichever occurs later 
± 7 days) and 30-day safety follow-up visit(± 7 days) after the last dose, but 70 day safety 
follow-up visit, post-ti·eatment response assessments, long-te1m follow-up after SCT, and 
smvival follow-up are not required. 
6.10.1. 
Criteria for Discontinuation of Study Treatment 
Reasons for discontinuation of study ti·eatment are provided in Section 3.5. 
6.11. 
End of Study 
The end of the entire study for all patients and for individual patients is defined in Section 3.6. 
6.12. 
Poststudy Care 
Upon withdrawal from study ti·eatment, patients will receive the care upon which they and their 
physicians agree. Poststudy h'eatment assessments are described in Table 24 and Table 28. 
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For patients who start new anti-AML therapy (other than SCT and maintenance therapy) before a 
relapse, efficacy status will be collected until relapse. Post-study anti-AML therapy status and 
status will not be collected and response assessments will no longer be required for patients 
discontinuing study treatment in the event of study termination due to futility.
6.13.
Sample Storage
The stored biological samples may be used by Gilead or its research partners for future testing to 
provide additional data to answer questions that relate to the main study. At the end of this study, 
these samples may be retained in storage by Gilead for a period up to 15 years. If subjects 
provide additional specific consent, residual PK samples may be destroyed no later than 15 years 
after the end of study or per country requirements.


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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events and Serious Adverse Events
7.1.1.
Adverse Events
An AE is any untoward medical occurrence in a clinical study participant administered a study 
drug, which does not necessarily have a causal relationship with the treatment. An AE can 
therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated 
with the use of a study drug, whether or not the AEs is considered related to the study drug. 
Adverse events may also include pretreatment or posttreatment complications that occur as a 
result of protocol-specified procedures or special situations (Section 7.1.3).
An AE does not include the following:
•
Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion. 
The condition that led to the procedure may be an AE and must be reported.
•
Preexisting diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen.
•
Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions).
•
Overdose without clinical sequelae (Section 7.1.3).
•
Any medical condition or clinically significant laboratory abnormality with an onset date 
before the ICF is signed and not related to a protocol-associated procedure is not an AE but 
rather considered to be preexisting and should be documented as medical history.
Preexisting events that increase in severity or change in nature after study drug initiation or as a 
consequence of participation in the clinical study will also be considered AEs.
7.1.2.
Serious Adverse Events
An SAE is defined as an event that, at any dose, results in the following:
•
Death.
•
A life-threatening situation (Note: The term “life-threatening” in the definition of “serious” 
refers to an event in which the patient was at risk of death at the time of the event; it does not 
refer to an event that hypothetically might have caused death if it were more severe).
•
In-patient hospitalization or prolongation of existing hospitalization.
•
Persistent or significant disability/incapacity.


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•
A congenital anomaly/birth defect.
•
A medically important event or reaction: Such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the patient or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse.
7.1.2.1.
Protocol-Specific Adverse Event/Serious Adverse Event Clarifications
Given the primary and secondary endpoints of the study, in order to maintain study integrity, the 
following events that are assessed as unrelated to study drug will not be considered AEs/SAEs:
•
Progression of AML
•
Deaths related to progression of AML
Events that are considered to represent progression of the underlying AML should not be 
recorded as AEs/SAEs. These data will be captured as efficacy assessment data only. If there is 
any uncertainty as to whether an event is due to disease progression, it should be reported as an 
AE/SAE.
Death that is attributed by the investigator as solely due to progression of AML and that occurs 
during the protocol-specified AE reporting period should be recorded only on the death eCRF 
(ie, not collected as an SAE on the AE eCRF).
7.1.2.1.1.
Deaths Not Related to AML Progression
All other deaths (ie, deaths that are not due to AML progression) occurring during the protocol-
specified AE reporting period, regardless of attribution, will be recorded on the AE eCRF and 
reported within 24 hours of awareness and no later than the next business day.
When recording a death on the eCRF, the event or condition that is considered the primary cause 
of death should be the AE term, and the outcome should be death. A patient can only have 1 AE 
(SAE) with outcome of death and severity of Common Terminology Criteria for Adverse Events 
(CTCAE) Grade 5.
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports
Special situation reports (SSRs) include all reports of medication error, abuse, misuse, overdose, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit of falsified medicine, and 
pregnancy regardless of an associated AE.


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Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration or administration of a study drug while the medication is in the control of a health 
care professional, patient, or consumer. Medication errors may be classified as a medication error 
without an AE, which includes situations of missed dose, medication error with an AE, 
intercepted medication error, or potential medication error.
Abuse is defined as persistent or sporadic intentional excessive use of a study drug by a 
participant.
Misuse is defined as any intentional and inappropriate use of a study drug that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a study 
drug given per administration or cumulatively which is above the maximum recommended dose 
as per protocol or in the product labelling (as it applies to the daily dose of the participant in 
question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the subject has taken the excess dose(s). Overdose cannot be established 
when the subject cannot account for the discrepancy, except in cases in which the investigator 
has reason to suspect that the subject has taken the additional dose(s).
Occupational exposure is defined as exposure to a study drug as a result of one’s professional or 
nonprofessional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial.
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead study drug.
Counterfeit or falsified medicine: Any study drug with a false representation of (a) its identity, 
(b) its source, or (c) its history.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for 
causality and severity, and for final review and confirmation of accuracy of event information 
and assessments.
7.2.1.
Assessment of Causality for Study Drugs and Procedures
The investigator or qualified subinvestigator is responsible for assessing the relationship to study 
drug using clinical judgment and the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an 
alternative causality must be provided (eg, preexisting condition, underlying disease, 
intercurrent illness, or concomitant medication).
•
Yes: There is reasonable possibility that the event may have been caused by the study drug.


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It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of AE reporting.
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:
•
No: Evidence exists that the AE has an etiology other than the study procedure.
•
Yes: The AE occurred as a result of protocol procedures, (eg, venipuncture).
7.2.2.
Assessment of Severity 
The severity of AEs will be graded using the National Cancer Institute Common Terminology 
Criteria for Adverse Events [NCI CTCAE], Version 5.0. For each episode, the highest grade 
attained should be reported as defined in the Toxicity Grading Scale (Appendix 4).
7.3.
Investigator Reporting Requirements and Instructions
7.3.1.
Requirements for Collection Prior to Study Drug Initiation
After informed consent, but prior to initiation of study medication, the following types of events 
must be reported on the applicable eCRFs: all SAEs and AEs related to protocol-mandated 
procedures.
7.3.2.
Adverse Events
Following initiation of study medication, all AEs, regardless of cause or relationship, will be 
collected until 70 days after last administration of study drug and reported on the eCRFs as 
instructed.
All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead may 
request that certain AEs be followed beyond the protocol-defined follow-up period.
In the event the study meets futility, and the sponsor decides to terminate the study, AEs that 
occur following initiation of study treatment, regardless of cause or relationship, will be 
collected until 30 days (± 7 days) after last administration of study drug and reported on the 
eCRFs as instructed. 
7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occurs after the patient first consents to 
participate in the study (ie, signing the ICF) and throughout the duration of the study, including 
the posttreatment follow-up visit, must be reported on the applicable eCRFs and Patient Safety 
(GLPS) as instructed below in this section. This also includes any SAEs resulting from protocol-
associated procedures performed after the ICF is signed.


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Any SAEs and deaths that occur after the posttreatment follow-up visit but within 70 days of the 
last dose of study drug, regardless of causality, should also be reported. In the event the study 
meets futility, and the sponsor decides to terminate the study, SAEs that occur after the 30 days 
(± 7 days) posttreatment follow-up visit may be reported if the SAE is considered as related to 
study drug by the investigator.
Investigators are not obligated to actively seek SAEs after the protocol-defined follow-up period; 
however, if the investigator learns of any SAEs that occur after the protocol-defined follow-up 
period has concluded and the event is deemed relevant to the use of study drug, the investigator 
should promptly document and report the event to Gilead (GLPS).
Instructions for reporting SAEs are described in Section 7.4.1.
7.3.4.
Study Drug Special Situations Reports
All study drug SSRs that occur from study drug initiation and throughout the duration of the 
study, including the posttreatment follow-up visit, must be reported to GLPS (Section 7.4.2). 
Adverse events and SAEs resulting from SSRs must be reported in accordance to the AE and 
SAE reporting guidance (Section 7.4).
7.3.5.
Concomitant Therapy Reports
7.3.5.1.
Gilead Concomitant Therapy Special Situations Report
Special situation reports involving a Gilead concomitant therapy (not considered study drug), 
that occurs after the subject first consents to participate in the study (ie, signing the informed 
consent) and throughout the duration of the study, including the posttreatment follow-up visit, 
must be reported to Gilead GLPS utilizing the paper SSR (Section 7.4.2.2).
7.3.5.2.
Non-Gilead Concomitant Therapy Report
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the SSR form; however, for special situations that result in AEs due to a non-Gilead concomitant 
medication, the AE should be reported on the AE form.
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
All clinical sequelae in relation to these SSRs will be reported as AEs or SAEs at the same time 
using the AE eCRF and/or the SAE report form. Details of the symptoms and signs, clinical 
management, and outcome will be reported, when available.


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7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports
7.4.1.
Serious Adverse Event Reporting Process
•
For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be transmitted by email or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.
•
Additional information may be requested to ensure the timely completion of accurate safety 
reports.
•
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s eCRF and the SAE narrative section of the Safety Report 
Form eCRF.
7.4.1.1.
Electronic Serious Adverse Event Reporting Process
•
Site personnel will record all SAE data on the applicable eCRFs and from there transmit the 
SAE information to Gilead GLPS within 24 hours of the investigator’s knowledge of the 
event from ICF signature throughout the duration of the study, including the 
protocol-required posttreatment follow-up period.
•
If it is not possible to record and transmit the SAE information electronically, record the SAE 
on the paper SAE reporting form and transmit within 24 hours:
Gilead GLPS
Email: Safety_fc@gilead.com
or
Fax: 1-650-522-5477
•
If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary. If the database is not locked, any SAE reported via paper must be 
transcribed as soon as possible on the applicable eCRFs and transmitted to GLPS.
7.4.2.
Special Situations Reporting Process
7.4.2.1.
Paper Special Situations Reporting Process for Study Drug
•
All SSRs will be recorded on the special situations report form and transmitted by emailing 
or faxing the report form within 24 hours of the investigator’s knowledge of the event to the 
attention of Gilead GLPS from study drug initiation throughout the duration of the study, 
including the protocol-required posttreatment follow-up period.


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Gilead GLPS
Email: Safety_fc@gilead.com
or
Fax: 1-650-522-5477
7.4.2.2.
Reporting Process for Gilead Concomitant Medications
•
Special situations that involve Gilead concomitant medications that are not considered study 
drug must be reported within 24 hours of the investigator’s knowledge of the event to Gilead 
GLPS utilizing the paper special situations report form to:
Gilead GLPS
Email: Safety_fc@gilead.com
or
Fax: 1-650-522-5477
•
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
•
Special situations involving non-Gilead concomitant medications do not need to be reported 
on the SSR form; however, special situations that result in AEs due to a non-Gilead 
concomitant medication, must be reported as an AE.
7.4.2.3.
Pregnancy Reporting Process
•
The investigator should report pregnancies in female patients that are identified after 
initiation of study drug and throughout the study, including the post study drug follow-up 
period, to Gilead GLPS using the pregnancy report form within 24 hours of becoming aware 
of the pregnancy. Contact details for transmitting the pregnancy report form are as follows:
Gilead GLPS
Email: Safety_fc@gilead.com
or
Fax: 1-650-522-5477
•
The pregnancy itself is not considered an AE, nor is an induced elective abortion to terminate 
a pregnancy without medical reasons.
•
All other premature terminations of pregnancy (eg, a spontaneous abortion, an induced 
therapeutic abortion due to complications or other medical reasons) must be reported within 
24 hours as an SAE, as described in Section 7.4.1. The underlying medical reason for this 
procedure should be recorded as the AE term.


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•
A spontaneous abortion is always considered to be an SAE and will be reported as described 
in Section 7.4.1. Furthermore, any SAE occurring as an adverse pregnancy outcome post 
study must be reported to the Gilead GLPS.
•
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy should be reported to Gilead GLPS using the 
pregnancy outcome report form. If the end of the pregnancy occurs after the study has been 
completed, the outcome should be reported directly to Gilead GLPS. Gilead GLPS contact 
information is as follows: email: Safety_FC@gilead.com and fax: +1 (650) 522-5477.
•
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements.
7.5.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs which may be in the form of line-listings, serious 
adverse drug reactions, or suspected unexpected serious adverse reactions (SUSARs). In 
accordance with the EU Clinical Trials Directive (2001/20/EC), Gilead or a specified designee 
will notify worldwide regulatory agencies and the relevant IEC in concerned Member States of 
applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the IB or relevant local label as applicable.
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study drug. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy.
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not to be recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require 
medical or surgical intervention or lead to study drug interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, ECG, x-rays, vital signs) that are associated with 
signs and/or symptoms must be recorded as an AE or SAE if they meet the definition of an AE 
or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory abnormality is part of a 
syndrome, record the syndrome or diagnosis (eg, anemia), not the laboratory result (ie, decreased 
hemoglobin).


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Severity should be recorded and graded according to the NCI CTCAE, Version 5.0. For AEs 
associated with laboratory abnormalities, the event should be graded on the basis of the clinical 
severity in the context of the underlying conditions; this may or may not be in agreement with 
the grading of the laboratory abnormality.
7.7.
Abnormal Liver Function Tests
Liver toxicity will be evaluated for all patients.
In the absence of an explanation for increased liver function tests, such as viral hepatitis, 
pre-existing or acute liver disease, or exposure to other agents associated with liver injury, the 
patient may be discontinued from the study treatment if the investigator determines that it is not 
in the patient’s best interest to continue. Discontinuation of treatment should be considered if 
there is an indication of severe liver injury according to Hy’s Law, defined by FDA Guidance for 
Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation {U.S. Department of 
Health & Human Services (DHHS) 2009}, as:
•
Treatment-emergent ALT or AST elevation (≥ 3 x ULN), AND
•
Treatment-emergent total bilirubin elevation (> 2 x ULN), and absence of cholestasis 
(defined as alkaline phosphatase < 2 x ULN), AND
•
No other good explanation for the injury (hepatitis A, B, C, or other viral hepatic injury, 
alcohol ingestion, congestive heart failure, worsening liver metastases).
7.8.
Toxicity Management
7.8.1.
Magrolimab
7.8.1.1.
Anemia, Blood Cross-matching, and Packed Red Blood Cell Transfusion 
Procedures
Magrolimab binds to RBCs and leads to erythrophagocytosis. CD47 is a member of the Rh 
complex in the RBC’s membrane. Therefore, when magrolimab binds to CD47, it is likely to 
interfere with routine blood bank tests needed in case of transfusion. Notify blood transfusion 
centers/blood banks of this interference with blood bank testing and inform them that a patient 
will receive magrolimab.
In clinical studies, anemia is the most common treatment-related AE and is typically manifested 
as a decline in hemoglobin of about 0.5 g/dL to 1.5 g/dL observed in the first 1 to 2 weeks of 
treatment. Significant drops (up to 3 g/dL or more) have also been observed in early doses. For 
patients with significant diseases or medical conditions, such as unstable angina, ischemic heart 
disease, or uncontrolled diabetes mellitus, treatment-related anemia could be life-threatening or 
fatal. 
Within 24 hours prior to each of the first 2 doses of magrolimab infusion during initial treatment, 
all patients must have a documented hemoglobin ≥ 9 g/dL. Patients who do not meet these 
criteria must be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of 
the first 2 doses of magrolimab.


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Patients with a low baseline hemoglobin level, especially those with cardiac history or risk 
factors, must be monitored closely after initial administrations of magrolimab as preexisting 
anemia could be exacerbated. Red blood cell transfusions are permitted prior to study treatment 
to ensure adequate hemoglobin level and as per the investigator’s clinical judgment.
Prior to initiation of magrolimab, ABO/Rh type, antibody screen, DAT, and extended RBC 
phenotyping (including minor antigens such as CcDEe, Cw, MNSs, Kk, FyaFyb, and JkaJkb) 
must be performed for each patient. RBC genotyping instead of extended RBC phenotyping is 
acceptable for any patient. RBC genotyping (instead of an extended RBC phenotyping) must be 
performed if a patient received any RBC or whole blood transfusion within the previous 
3 months (unless laboratory has availability for special techniques for performing phenotyping 
for patients with a recent transfusion). Results must be available before the first dose of 
magrolimab.
7.8.1.1.1.
For Patients After Exposure to Magrolimab
An additional hemoglobin must be checked 3 to 6 hours after the initiation of the first and second 
doses of magrolimab during initial treatment. The patient should be transfused as clinically 
appropriate. Investigators should consider additional hemoglobin monitoring during the first 
week of treatment in patients with symptoms of anemia or at increased risk for complications of 
anemia.
7.8.1.1.2.
Blood Components for Transfusion
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated units 
per institutional guidelines. 
For RBC phenotype/genotype matched units are preferred. However, cytomegalovirus (CMV)-
seronegative units for CMV-seronegative patients are not required for this study.
In case ABO/Rh type cannot be resolved, use units matched for pretreatment (historical) 
phenotype/genotype matched units and for minor RBC antigens (CcDEe and Kk, to the feasible 
extent). Regarding the ABO type, historical blood group or O type can be used as per the 
institutional guidelines.
For emergency transfusions, the transfusion centers may consider using emergency Group O red 
cells if phenotype/genotype matched units are not available. 
Whenever possible, blood plasma therapy should be blood type specific. Platelets should be 
blood type compatible whenever possible and, if not, should have been tested and found not to 
have high titer anti-A or anti-B. Otherwise, plasma and platelet products can be provided as per 
the institutional policy. 
A recent report has suggested that cross-match interference by RBCs due to treatment with 
magrolimab may be resolved by using gamma-clone anti-IgG and multiple alloadsorptions with 
papain-treated RBC samples, pooled single donor apheresis platelets or commercial human 
platelet concentrate product if required {Troughton 2018, Velliquette 2019}.


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7.8.1.2.
Management of Infusion-related Reactions
Infusion-related reactions are defined by the NCI CTCAE, Version 5.0 (under the category 
“General disorders and administration site conditions”) as “a disorder characterized by adverse 
reaction to the infusion of pharmacological or biological substances” (Appendix 4). For the 
purposes of this study, the time frame for infusion-related reaction assessment is the 24- hour 
period beginning from the start of the infusion. Premedication use described in Section 5.9 will 
be used to manage infusion-related reactions preemptively.
Recommendations for the management of infusion-related reactions are in Table 16:
Table 16.
Management of Infusion-related Reactions
Infusion-related Reactions
CTCAE Grade 
Management
Grade 1
Mild transient reaction.
Remain at bedside and monitor patient until recovery from symptoms. 
Patients who experience IRRs with the first 2 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
Grade 2
Requiring symptomatic treatment 
and prophylactic medications for 
≤ 24 hours.
Interrupt magrolimab therapy per protocol and begin an IV infusion of 
normal saline and consider treating the patient with diphenhydramine 50 mg 
IV (or equivalent) and/or 500 to 750 mg of oral acetaminophen.
Remain at bedside and monitor patient until resolution of symptoms.
Corticosteroid therapy may also be given at the discretion of the investigator.
If the infusion is interrupted, wait until symptoms resolve, then restart the 
infusion at 50% of the original infusion rate.
If no further complications occur after 1 hour (± 10 minutes), the rate may be 
increased to 100% of the original infusion rate. Monitor the patient closely.
If symptoms recur, stop infusion and disconnect patient from the infusion 
apparatus. No further magrolimab will be administered at that visit.
Patients who experience IRRs with the first 2 doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion.
The amount of magrolimab infused must be recorded on the eCRF.
Patients who experience a Grade 2 infusion-related reaction during the 
postinfusion observation period that does not resolve to ≤ Grade 1 during that 
time should be observed until the AE resolves or stabilizes, with vital sign 
measurements as medically indicated for the management of the AE.
Grade 3-4
Grade 3: Prolonged reactions or 
recurrence of symptoms 
following initial improvement, or 
where hospitalization is indicated 
for other clinical sequelae.
Grade 4: Life-threatening 
consequences, where urgent 
intervention is indicated.
Immediately discontinue infusion of magrolimab.
Begin an IV infusion of normal saline and consider treating the patient as 
follows: Administer bronchodilators, epinephrine 0.2 to 1 mg of a 1:1000 
solution for SC administration or 0.1 to 0.25 mg of a 1:10,000 solution 
injected slowly for IV administration and/or diphenhydramine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed.
The patient should be monitored until the investigator is comfortable that the 
symptoms will not recur.


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Infusion-related Reactions
CTCAE Grade 
Management
Patients who experience Grade 3 IRRs must be given premedication prior to 
subsequent doses. In this setting, premedication with oral acetaminophen 
(650 to 1000 mg), oral or IV diphenhydramine (25 to 50 mg), and IV 
dexamethasone (4 to 20 mg), or a comparable regimen, is recommended for 
the subsequent 2 doses. Continued premedication with corticosteroids 
beyond these 2 doses may be administered at the discretion of the treating 
physician. 
Patients who receive premedication and still experience a recurrent Grade 3 
IRR or patients who experience a Grade 4 IRR at any time should be 
permanently discontinued from the study treatment.
For anaphylaxis, investigators should follow their institutional guidelines for 
treatment.
All patients with a Grade 3 or higher IRR will be observed until the AE 
resolves or stabilizes, with vital sign measurements and additional 
evaluations as medically indicated for the management of the AE.
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; eCRF = electronic case report form; 
IV = intravenous
7.8.1.3.
Thromboembolic Events
Thromboembolic events, including deep vein thromboses and pulmonary embolisms, have been 
reported in some patients receiving magrolimab, sometimes early in therapy. Available data for 
magrolimab do not support a clear or consistent relationship between clinical thromboembolic 
events and magrolimab use. Patients should be closely monitored for the symptoms of 
thromboembolic events and treated accordingly.
7.8.1.4.
Severe Neutropenia 
Severe neutropenia and febrile neutropenia have been reported in patients treated with 
magrolimab. Close monitoring of hematologic parameters (Appendix 2, Table 22, Table 27) 
including neutrophils is required for all patients treated with magrolimab. Prophylactic 
antibiotics and/or antimycotics should be considered. Administer granulocyte-colony stimulating 
factor, if clinically indicated. 
Recommendations for magrolimab dose delay in case of severe neutropenia is provided in 
Section 5.10.1.1 
7.8.1.5.
Serious Infections
Serious infections have been reported in patients treated with magrolimab. Grades 3 and 4 
infections have been reported in patients treated with magrolimab, including fatal events of 
pneumonia and sepsis. Patients (with or without neutropenia) should be regularly monitored for 
signs and symptoms of infection. For patients with prolonged neutropenia or patients at risk, 
consider infection prophylaxis including antibiotics (eg fluoroquinolone) or antifungal agents (eg 
oral triazoles or parenteral echinocandin) in accordance with current guidelines


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For serious infections, hold the next dose of magrolimab until the infection has resolved 
clinically. For serious infections that remain active for ≥ 14 days, consider discontinuation of 
magrolimab.
7.8.1.6.
Management of Pneumonitis
Pneumonitis has been infrequently observed in patients receiving magrolimab. Generally, 
immune-related AEs have not been observed in clinical use with magrolimab. In contrast to 
T-cell checkpoint inhibitors, magrolimab primarily exerts its antitumor efficacy through 
macrophage-mediated phagocytosis of tumor cells. Nonspecific T-cell or other host immune 
responses that are seen with T-cell checkpoint inhibitors have not been observed with 
magrolimab in nonclinical studies. Additionally, no events of macrophage activation syndrome 
or hemophagocytic lymphohistiocytosis have been reported in clinical studies.
In instances of suspected pneumonitis, first rule out non-inflammatory causes (eg, infections). If 
a non-inflammatory cause is identified, treat accordingly and continue therapy per protocol. 
Evaluate with imaging (eg, chest x-ray or computed tomography) and pulmonary consultation.
Management of potential pneumonitis is detailed in Table 17 and follows the American Society 
of Clinical Oncology (ASCO) guidelines for immune-related AEs {Brahmer 2018}. Patients who 
experience Grade 3-4 pneumonitis will be permanently discontinued from study treatment.
Table 17.
Pneumonitis Management Algorithm
Pneumonitis
CTCAE Grade of Pneumonitis
Management
Follow-Up
Grade 1
Radiographic changes (CXR or 
CT) only.
Monitor for signs and 
symptoms weekly and consider 
monitoring with CXR.
Consider pulmonary and 
infectious disease consults.
Consider re-imaging with CT in 3-4 
weeks as clinically indicated.
May resume magrolimab with 
radiographic evidence of improvement or 
resolution.
If no clinical improvement or worsening, 
treat as Grade 2.
Grade 2
Mild to moderate new 
symptoms.
Interrupt magrolimab therapy 
per protocol.
Pulmonary and infectious 
disease consults.
Consider empirical antibiotics.
Monitor signs and symptoms 
every 2-3 days; consider 
hospitalization.
1 mg/kg/day oral prednisone or 
IV equivalent.
Consider bronchoscopy, lung 
biopsy.
Re-image every 1-3 days.
If improving to baseline, taper 
corticosteroids over 4-6 weeks and 
resume magrolimab therapy per protocol.
If no clinical improvement after 48-72 
hours or worsening, treat as Grade 3-4.


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Pneumonitis
CTCAE Grade of Pneumonitis
Management
Follow-Up
Grade 3-4
Severe new symptoms; 
new/worsening hypoxia; life-
threatening.
Discontinue magrolimab 
therapy.
Hospitalize.
Pulmonary and infectious 
disease consults.
1-2 mg/kg/day 
methylprednisolone IV or IV 
equivalent.
Add empirical antibiotics and 
consider prophylactic 
antibiotics for opportunistic 
infections.
Consider bronchoscopy, lung 
biopsy.
If improving to baseline, taper 
corticosteroids over 4-6 weeks.
If no clinical improvement after 48 hours 
or worsening, consider additional 
immunosuppression (eg, infliximab, 
cyclophosphamide, IV immunoglobulin, 
mycophenolate mofetil).
CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; CXR = chest x-ray; 
IV = intravenous.
7.8.2.
Venetoclax
Safety management guidelines for venetoclax are described in 5.10.2. Additional safety 
guidelines are provided in the venetoclax prescribing information.
7.8.3.
Azacitidine
Safety management guidelines for azacitidine are described in Section 5.10.1.2. Additional 
safety guidelines are provided in the azacitidine prescribing information.
7.8.4.
Cytarabine
Safety management guidelines for cytarabine are provided in the cytarabine prescribing 
information.
7.8.5.
Daunorubicin
Safety management guidelines for daunorubicin are provided in the daunorubicin prescribing 
information.
7.8.6.
Idarubicin
Safety management guidelines for idarubicin are provided in the idarubicin prescribing 
information.


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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
The study objectives and endpoints are provided in Table 1.
8.2.
Planned Analyses
The overall study-wide type I error is 1-sided 0.025. To protect the integrity of the study, an 
administrative 1-sided type I error of 0.0001 will be spent for the interim futility analysis 
(Section 8.2.1.1). As a result, a 1-sided type I error 0.0249 will be left for the superiority analysis 
of the primary and key secondary efficacy endpoints.
8.2.1.
Interim Analyses
Two interim analyses are planned. The first interim analysis is the analysis of OS futility. The 
second interim analysis is for OS superiority. In the event the study meets futility, and the 
sponsor decides to terminate the study, the planned interim analysis for OS superiority will no 
longer be required.
8.2.1.1.
Interim Futility Analysis
This interim analysis for futility will be performed after approximately 69 deaths (40% of the 
expected 171 OS events) in the stratum of patients appropriate for non-intensive therapy have 
occurred. The analysis will include a stratified log-rank test for OS in the stratum of patients 
appropriate for non-intensive therapy and will be reviewed by an external data monitoring 
committee (DMC). An administrative 1-sided type I error 0.0001 will be allocated to this 
analysis to protect the study integrity. A non-binding futility rule with a boundary HR = 1.1 will 
be implemented. The DMC may make a recommendation to terminate the study for futility if the 
observed HR for the OS in patients appropriate for non-intensive therapy is larger than 1.1. 
When the true OS HR in patients appropriate for non-intensive therapy is 0.74, the probability of 
observing HR > 1.1 at the interim analysis is less than 5%.
8.2.1.2.
Interim Efficacy Analysis for Superiority
An interim efficacy analysis for OS superiority will be performed after approximately 128 deaths 
(75% of the expected 171 OS events) in the stratum of patients appropriate for non-intensive 
therapy have occurred, outstanding data queries have been resolved or adjudicated as 
unresolvable, and the data have been cleaned and finalized.
The Lan-DeMets approach with O-Brien-Fleming type alpha spending function will be used for 
the interim analysis and primary analysis for OS in the stratum of patients appropriate for 
non-intensive therapy. The stopping boundaries for each analysis are provided in Table 18.


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Table 18.
Stopping Boundaries for Efficacy Analyses for Superiority
Stopping Boundary
Efficacy Analysis
Events (%a)
HR 
1-Sided P-Value 
IA
128 (75%)
0.661
0.010
Primary Analysis
171 (100%)
0.735
0.022
HR = hazard ratio; IA = interim analysis; OS = overall survival
a
Information fraction = number of events/total number of events × 100
To strongly control the overall type I error across the testing of the primary and key secondary 
efficacy endpoints, a hierarchical testing strategy will be performed with a predefined order as 
listed in the protocol and the statistical analysis plan (SAP). The primary efficacy endpoint of OS 
in the stratum of patients appropriate for non-intensive therapy will be tested for superiority first 
at the significance level specified in Table 18. If the superiority is established, analysis of key 
secondary efficacy endpoints will be performed. For each key secondary endpoint, an 
O’Brien-Fleming boundary will be derived based on the information fraction defined at the 
interim analysis and the remaining type I error, respectively, per Table 19.
Table 19.
Definition of Information Fraction
Secondary Endpoint
Information Fraction at the Interim Analysis
OS in all patients 
75%, same with that of primary efficacy endpoint
EFS in all patients
75%, same with that of primary efficacy endpoint
Transfusion independence conversion rate in all 
patients
Proportion of patients who have at least 9 months follow-up 
since randomization
Rate of CR within 6 months of treatment (2 
months for patients receiving 7 + 3 
chemotherapy)
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
Rate of CRMRD− within 6 months of treatment (2 
months for patients receiving 7 + 3 
chemotherapy) 
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
Rate of CR + CRh within 6 months of treatment 
(2 months for patients receiving 7 + 3 
chemotherapy)
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
CR = complete remission; CRh = complete remission with partial hematologic recovery; CRMRD− = complete remission without 
minimal residual disease; EFS = event-free survival 
The key secondary endpoints will be tested in the following order:
•
OS in all patients
•
EFS in all patients
•
Transfusion independence conversion rate in all patients


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•
Rate of CR within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy)
•
Rate of CRMRD− within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy)
•
Rate of CR + CRh within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy)
A given hypothesis can only be tested and declared statistically significant if all previous 
hypotheses tested in the hierarchy are also statistically significant.
At the time of each planned interim analysis, the DMC will review the analysis results, and 
provide recommendations. The process details are described in Section 8.12. Details for the 
planned interim analyses will be provided in the DMC Charter and the SAP.
8.2.2.
Primary Analysis
If the null hypothesis on the primary endpoint of OS is not rejected in the interim efficacy 
analysis, the primary analysis will be conducted when 171 deaths have occurred in the stratum of 
patients appropriate for non-intensive therapy. The analysis will be conducted after all 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized for the analysis. The same hierarchical testing strategy with the order 
as defined in Section 8.2.1.2 will be used.
If the null hypothesis of the primary endpoint OS is rejected in the interim efficacy analysis, the 
primary analysis timing will be determined by the maturity of the key secondary endpoints that 
have not been rejected in the interim analysis.
In the event the study meets futility, and the sponsor decides to terminate the study, the planned 
primary analysis will no longer be required.
8.2.3.
Final Analysis
The final analysis will be performed after all patients have completed the study and outstanding 
data queries have been resolved or adjudicated as unresolvable, and the data have been cleaned 
and finalized. The analysis of the primary endpoint of OS may be conducted at this time but this 
will be descriptive in nature.


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8.3.
Analysis Conventions
8.3.1.
Analysis Sets
8.3.1.1.
Efficacy
The primary analysis set for efficacy analysis is the Intent-to-Treat (ITT) analysis set, defined as 
all randomized patients according to the treatment arm to which the patients are randomized, 
unless otherwise specified.
8.3.1.2.
Safety
The primary analysis set for safety analyses is the Safety Analysis Set, defined as all patients 
who received at least 1 dose of any study treatment, with treatment assignments designated 
according to the actual treatment received.
All data collected during treatment up to 70 days after treatment discontinuation will be included 
in the safety summaries.
8.3.1.3.
Pharmacokinetics
The PK analysis will be conducted on Pharmacokinetic Analysis Set, defined as all randomized 
patients who received at least 1 dose of magrolimab and have at least 1 measurable posttreatment 
serum concentration of magrolimab.
8.3.1.4.
Immunogenicity
The Immunogenicity Analysis Set is defined as all randomized patients who received at least 
1 dose of magrolimab and had at least 1 evaluable anti-magrolimab antibody test result.
8.3.1.5.
Biomarker
The Biomarker Analysis Set includes all randomized patients who received at least 1 dose of any 
study drug and have at least 1 evaluable biomarker measurement available. This will be the 
primary analysis set for all biomarker data analyses.
8.3.2.
Data Handling Conventions
By-patient listings will be created for important variables from each eCRF module. Summary 
tables for continuous variables will contain the following statistics: N (number in analysis set), 
n (number with data), mean, standard deviation, 95% CIs on the mean, median, minimum, and 
maximum. Summary tables for categorical variables will include: N, n, percentage, and 95% CIs 
on the percentage. Unless otherwise indicated, 95% CIs for binary variables will be calculated 
using the binomial distribution (exact method) and will be 2-sided. Data will be described and 
summarized by treatment arm.


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The baseline value used in each analysis will be the last (most recent) pretreatment value before 
or on the first dosing date of study treatment. As appropriate, changes from baseline to each 
subsequent time point will be described and summarized. Similarly, as appropriate, the best 
change from baseline during the study will also be described and summarized. Graphical 
techniques (ie, waterfall plots, Kaplan-Meier curves, line plots) may be used when such methods 
are appropriate and informative. Analyses will be based upon the observed data unless methods 
for handling missing data are specified. If there is a significant degree of non-normality, analyses 
may be performed on log-transformed data or nonparametric tests may be applied, as appropriate.
8.4.
Demographic and Baseline Characteristics Analysis
Demographic and baseline measurements will be summarized using standard descriptive 
methods. Demographic summaries will include age, sex, race/ethnicity, and randomization 
stratification group. Baseline data will include a summary of body weight, height, body surface 
area, body mass index, World Health Organization AML classification, and ECOG performance 
status.
8.5.
Efficacy Analysis
8.5.1.
Primary Endpoint Analysis
Formal hypothesis testing will be performed to test the statistical hypothesis that the distribution 
of OS between the experimental arm and the control arm in patients appropriate for 
non-intensive therapy is the same (null hypothesis) versus that the experimental arm is superior 
to the control arm in terms of survival function (alternative hypothesis).
A log-rank test stratified by the randomization stratification factors will be used to compare the 
treatment differences in OS. A stratified Cox proportional hazard regression model will be used 
to estimate HR and its 2-sided 95% CI. In addition, the Kaplan-Meier method will be used to 
estimate median OS with its 95% CI, and the Kaplan-Meier plots will be provided.
8.5.2.
Secondary Efficacy Endpoints Analyses
Analyses will be performed based on the patient populations on which the endpoints are defined. 
Analyses of OS in all patients and EFS will be similar to that of the primary efficacy endpoint 
OS in the stratum of patients appropriate for non-intensive therapy.
The point estimate of the CR rate and the corresponding 2-sided exact 95% CI based on 
Clopper-Pearson method will be provided for each treatment arm. The difference in CR rates 
between the 2 arms will be tested using the Cochran-Mantel-Haenszel test, stratified by the 
randomization stratification factors. The CRMRD− rate, CR + CRh rate, transfusion independence 
conversion rate will be evaluated in a similar manner as CR rate, except that transfusion 
independence conversion rate will be based on a subset of randomized patients who are 
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For the time-to-event endpoints of DCR and duration of CR + CRh in all patients, analyses will 
be conducted based on the subsets on which the outcome measures are defined. Specifically, the 
DCR will be based on patients who achieved CR within 6 months of treatment with magrolimab 
+ azacitidine or venetoclax + azacitidine, or within 2 months of 7 + 3 chemotherapy. Duration of 
CR + CRh will be based on patients who achieved CR or CRh within 6 months of treatment with 
magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of 7 + 3 chemotherapy. 
The Kaplan-Meier method will be used to estimate median duration with its 95% CI and 
Kaplan-Meier plots will be provided.
8.5.4.
Analyses by Appropriateness for Intensive or Non-intensive Therapy
Analyses of OS, EFS, rate of CR, rate of CRMRD−, rate of CR + CRh, transfusion independence 
conversion rate, and TTD on the GHS/QoL scale and the physical functioning scale of the 
EORTC QLQ-C30 will be conducted in the stratum of patients appropriate for non-intensive 
therapy and those appropriate for intensive therapy, separately. The objective is to demonstrate 
that the efficacy in patients appropriate for intensive therapy is consistent with that in patients 
appropriate for non-intensive therapy. In the event the study meets futility, and the sponsor 
decides to terminate the study, the planned analysis as described will no longer be required.
8.6.
Safety Analysis
All safety data collected on or after the date that study drug was first dispensed up to the date of 
last dose of study drug + 70 days will be summarized by treatment group (according to the study 
drug received). Data for the pretreatment and treatment-free safety follow-up periods will be 
included in data listings. For categorical safety data including incidence of AEs and 
categorizations of laboratory data, count and percent of patients will be summarized. For 
continuous safety data including laboratory data, the number of patients, mean, standard 
deviation, minimum, quartiles, median, and maximum will be summarized.
8.6.1.
Extent of Exposure
A patient’s extent of exposure to study drugs data will be generated from the study drugs 
administration data. Exposure data will be summarized by treatment group.
8.6.2.
Adverse Events
Clinical and laboratory AEs will be coded using the MedDRA. System Organ Class, High-Level 
Group Term, High-Level Term, Preferred Term, and Lower-Level Term will be attached to the 
clinical database.
Events will be summarized on the basis of the date of onset for the event. A treatment-emergent 
AE will be defined as any AE that begins on or after the date of first dose of study drug up to and 
including the date of last dose of study treatment plus 70 days or the day before initiation of new 
anticancer therapy including SCT, whichever comes first.
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Summaries (number and percentage of patients) of treatment-emergent AEs (by System Organ 
Class and PT) will be provided by treatment group.
Adverse events that occurred before exposure to study treatment will be reported in the AE line 
listings and appropriately identified as non-treatment-emergent AEs.
8.6.3.
Laboratory Evaluations
Selected laboratory data (using conventional units) will be summarized using only observed data. 
Data and change from baseline at all scheduled time points will be summarized.
Graded laboratory abnormalities will be defined using the grading scheme in Appendix 4.
Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at 
least 1 toxicity grade from baseline at any time point postbaseline, up to and including the date of 
last dose of study treatment plus 70 days or the day before initiation of any new anticancer 
therapy including SCT, whichever comes first will be summarized by treatment group. If 
baseline data are missing, then any graded abnormality (ie, at least a Grade 1) will be considered 
treatment-emergent.
Laboratory abnormalities that occur before the first dose of study drug or after the patient has 
been discontinued from treatment for at least 70 days will be included in a data listing.
8.6.4.
Other Safety Evaluations
Vital signs and physical examination findings will be summarized at select time points. Details 
will be provided in the SAP.
8.7.
Pharmacokinetic Analysis
The PK Analysis Set will be used for summaries of PK concentration of magrolimab versus time. 
Due to the sparse nature of PK collection, PK parameters will not be calculated.
Summary statistics will be presented for magrolimab serum concentrations at each scheduled 
time point. Descriptive graphical plots of individual serum concentration versus time profiles and 
mean concentration versus time profiles will be generated.
Missing concentration values will be reported as is in data listings. Concentration values below 
lower limit of quantitation will be handled as zero in summary statistics and reported as is in data 
listings.
All data from this study may be combined with PK data from other company sponsored clinical 
studies and analyzed using a population PK model. Such an analysis would be reported 
separately.


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Analysis of Patient-Reported Outcome Data 
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The PRO endpoints, TTD on domain scales of the EORTC QLQ-C30, are defined based on the 
ITT Analysis Set. The TTDs will be summarized using the Kaplan-Meier method. The log-rank 
test stratified by randomization stratification factors will be conducted for the TTD comparison 
between treatment anns, and the HR estimated using a Cox propo1tional hazard regression model 
stratified by randomization stratification factors will be provided. 
Additional analyses may be conducted on PRO data, including absolute scores and changes from 
baseline for scales and single items of the EORTC QLQ-C30 instrument, the EQ-5D-5L 
instrument, and PGIS/PGIC at each assessment time point for each ann. A linear mixed effect 
model with treatment, time, tr·eatment by time interaction, str·atification factors, and baseline 
scores as fixed factors may be fitted for analyses of selective PRO endpoints. 
8.9. 
Immunogenicity Analysis 
Immunogenicity will be assessed using a 3-tier (screen, confnmato1y, and titer) approach on 
study samples using a validated immunoassay. The rate and magnitude of anti-magrolimab 
antibody incidence, prevalence, persistence, and tr·ansience will be summarized for the 
Immuno enici Anal sis Set. Titer summaries ma also be enerated, if relevant. 
Neutr·alizing antibody analysis will be conducted using a validated assay on ADA positive 
samples and results will be summarized. 
8.10. 
Biomarker Analysis 
The baseline level, absolute level, and change from baseline level over time may be summarized 
using descriptive statistics for each biomarker at the sam le collection time oint b treatment 
8.11. 
Sample Size Rationale 
Based on data from Study 5F9005, which emolled 47 TP53 mutant AML patients treated with 
magrolimab + azacitidine with a median OS of 12.9 months {Sallman 2020a}, and from studies 
for venetoclax in combination with hypomethylating agents that have shown a median OS 
ranging from 5.2 to 7.2 months in TP53 mutant AML patients {DiNardo 2019, Kim 2020}, it is 
assumed that administration of magrolimab + azacitidine to study patients will result in a median 
OS of approximately 9.77 months, improved from a median OS of 6.35 months in patients 
tr·eated with venetoclax + azacitidine or 7 + 3 chemotherapy. This conesponds to an OS HR of 
0.65. 
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It is assumed that the duration of OS is exponentially distributed in each of the 2 arms. With an 
HR equal to 1 under the null hypothesis of no difference between the 2 treatment arms, an HR 
of 0.65 under the alternative hypothesis of superiority of the magrolimab + azacitidine, a planned 
interim futility analysis when 40% of OS events are observed, and an interim superiority analysis 
when 75% of OS events are observed, 171 events (deaths) are required to achieve a power of 
79.7% based on a log-rank test with an overall 1-sided significance level of 0.025 in the stratum 
of patients appropriate for non-intensive therapy; approximately 234 deaths may be observed in 
all patients when 171 events occur in the stratum of patients appropriate for non-intensive 
therapy. That provides a power of 90.4% for the OS test in all patients based on the log-rank test.
The study will enroll a minimum of 228 patients appropriate for non-intensive therapy to ensure 
adequate events (171 deaths) for the primary endpoint analysis. The study enrollment may stop 
after 228 patients in the non-intensive therapy group or approximately 346 of all patients are 
enrolled, whichever occurs later. The study duration and the total number of patients to be 
enrolled will depend on the prevalence of patients appropriate for non-intensive therapy in the 
overall population. When the enrollment of the required number of all patients finishes later than 
that of patients in the non-intensive therapy group, assuming a planned accrual period of 
23 months, a study duration of 27 months, and an expectation that 10% of patients are likely to 
drop out by the end of study (annual dropout rate 4.8% assuming time to drop-out is 
exponentially distributed), approximately 173 patients in the experimental arm and 173 patients 
in the control arm (approximately 346 total) are to be enrolled. In the event the study meets 
futility, and the sponsor decides to terminate the study, no further patients will be enrolled.
8.12.
Data Monitoring Committee
An external multidisciplinary DMC will review the progress of the study and perform interim 
reviews of safety data on a regular basis and provide recommendation to Gilead as to whether the 
nature, frequency, and severity of adverse effects associated with study treatment warrant the 
early termination of the study in the best interests of the patients, whether the study should 
continue as planned, or the study should continue with modifications. The DMC may also 
provide recommendations as needed regarding study design.
In addition, the DMC will meet after approximately 69 and 128 OS events in the stratum of 
patients appropriate for non-intensive therapy have occurred to review the results from the 
interim futility analysis and superiority analysis, respectively. Based on the prespecified futility 
and superiority rules, the DMC may make recommendations to Gilead as to whether the study 
should be terminated early due to futility, should be stopped due to overwhelming efficacy, or 
should continue as planned.
The DMC’s specific activities will be defined by a mutually agreed charter, which will describe 
the DMC’s membership, conduct, and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.


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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with International Council 
for Harmonisation (ICH) E6(R2) addendum to its guideline for GCP and applicable laws and 
regulations.
9.1.2.
Financial Disclosure
The investigator and subinvestigators will provide prompt and accurate documentation of their 
financial interest or arrangements with Gilead, or proprietary interests in the study drug during 
the course of a clinical study. This documentation must be provided prior to the investigator’s 
(and any subinvestigator’s) participation in the study. The investigator and subinvestigator agree 
to notify Gilead of any change in reportable interests during the study and for 1 year following 
completion of the study. Study completion is defined as the date when the last patient completes 
the protocol-defined activities.
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval
The investigator (or Gilead as appropriate according to local regulations) will submit this 
protocol, ICF, and any accompanying material to be provided to the patient (such as 
advertisements, patient information sheets, or descriptions of the study used to obtain informed 
consent) to an IRB/IEC. The investigator will not begin any study patient activities until 
approval from the IRB/IEC has been documented and provided as a letter to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC any modifications made to the protocol or any accompanying material to be 
provided to the patient after initial IRB/IEC approval, with the exception of those necessary to 
reduce immediate risk to study patients.
9.1.4.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study before undertaking any study-related procedures. The investigator 
must use the most current IRB- or IEC-approved ICF for documenting written informed consent. 
Each ICF (or assent as applicable) will be appropriately signed and dated by the patient or the 
patient’s legally authorized representative, the person conducting the consent discussion, and an 
impartial witness (if required by IRB or IEC or local requirements).


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The ICF will inform patients about genomic testing and/or planned sample retention. In addition 
to the study-specific ICF to be signed by each patient participating in the study, patients will be 
required to document agreement or to allow the use of the remainder of their already collected 
specimens for 
future research, in accordance with applicable regulations. The results of 
the tests performed on the samples will not be given to the patient or the investigator.
9.1.5.
Confidentiality
The investigator must ensure that patients’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as year of birth) will be recorded on any form 
or biological sample submitted to Gilead, IRB/IEC, or the laboratory. Laboratory specimens 
must be labeled in such a way as to protect patient identity while allowing the results to be 
recorded to the proper patient. Refer to specific laboratory instructions. NOTE: The investigator 
must keep a screening log with details for all patients screened and enrolled in the study, in 
accordance with the site procedures and regulations. Patient data will be processed in accordance 
with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
IB, this protocol, CRFs/eCRFs, study drug information, and any other study information, remain 
the sole and exclusive property of Gilead during the conduct of the study and thereafter. This 
information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain.
9.1.6.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following 2 categories: (1) investigator’s study file, and (2) patient 
clinical source documents.
The investigator’s study file will contain the protocol/amendments, case report forms 
(CRFs)/eCRFs, IRB/IEC and governmental approval with correspondence, the ICF, drug 
records, staff curriculum vitae and authorization forms, and other appropriate documents and 
correspondence.
The required source data should include sequential notes containing at least the following 
information for each patient:
•
Patient identification
•
Documentation that patient meets eligibility criteria, ie, medical history, physical 
examination, and confirmation of diagnosis (to support inclusion and exclusion criteria)
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•
Documentation of the reason(s) a consented patient is not enrolled
•
Participation in study (including study number)
•
Study discussed and date of informed consent
•
Dates of all visits
•
Documentation that protocol-specific procedures were performed
•
Results of efficacy parameters, as required by the protocol
•
Start and end date (including dose regimen) of study drug, including dates of dispensing and 
return
•
Record of all AEs and other safety parameters (start and end date, and including causality 
and severity) and documentation that adequate medical care has been provided for any AE
•
Concomitant medication (start and end date; dose if relevant; dose changes)
•
Date of study completion and reason for early discontinuation, if it occurs
All clinical study documents must be retained by the investigator for at least 2 years or according 
to local laws, whichever is longer, after the last approval of a marketing application in an ICH 
region (ie, US, Europe) and until there are no pending or planned marketing applications in an 
ICH region; or, if no application is filed or if the application is not approved for such indication, 
for 2 years after the investigation is discontinued and regulatory authorities have been notified. 
Investigators may be required to retain documents longer if specified by regulatory requirements, 
by local regulations, or by an agreement with Gilead. The investigator must notify Gilead before 
destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
patient, appropriate copies should be made for storage away from the site.
9.1.7.
Case Report Forms
For each patient consented, an eCRF casebook will be completed by an authorized study staff 
member whose training for this function is completed in the electronic data capture 
(EDC) system. The eCRF casebook will only capture the data required per the protocol schedule 
of events and procedures. The Inclusion/Exclusion Criteria and Enrollment eCRFs should be 
completed only after all data related to eligibility have been received. Data entry should be 
performed in accordance with the CRF Completion Guidelines provided by the sponsor. 


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Subsequent to data entry, a study monitor will perform source data verification within the EDC 
system. System-generated or manual queries will be issued in the EDC system as data 
discrepancies are identified by the monitor or Gilead staff who routinely review the data for 
completeness, correctness, and consistency. The site investigator, site coordinator, or other 
designee is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (eg, data entry error). Original entries as well as any changes to data fields will be 
stored in the audit trail of the system. At a minimum, prior to any interim time points or database 
lock (as instructed by Gilead), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. At the conclusion of the study, Gilead will provide the site investigator with a 
read-only archive copy of the data entered by that site. This archive must be stored in accordance 
with the records retention requirements outlined in Section 9.1.6.
9.1.8.
Investigator Inspections
The investigator will make available all source documents and other records for this study to 
Gilead’s appointed study monitors, to IRBs/IECs, or to regulatory authority or health authority 
inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications may be made only by the sponsor.
9.2.2.
Study Reports and Publications
A clinical study report (CSR) will be prepared and provided to the regulatory agency(ies) when 
applicable and in accordance with local regulatory requirements. Gilead will ensure that the 
report meets the standards set out in the ICH Guideline for Structure and Content of Clinical 
Study Reports (ICH E3). Note that an abbreviated report may be prepared in certain cases. For 
studies with sites in countries following the EU Regulation No. 536/2014, a CSR will be 
submitted within 1 year (6 months for pediatric studies, in accordance with Regulation [EC] 
No. 1901/2006) after the global end of study (as defined in Section 3.6).
•
Investigators in this study may communicate, orally present, or publish study data in 
scientific journals or other scholarly media in accordance with the Gilead clinical trial 
agreement.


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9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol, eg, attendance at investigator meetings. If required under the applicable statutory and 
regulatory requirements, Gilead will capture and disclose to federal and state agencies any 
expenses paid or reimbursed for such services, including any clinical study payments, meal, 
travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any patient records needed to 
verify the entries in the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both Gilead and the investigator reserve the right to terminate the study at any time. Should this 
be necessary, both parties will arrange discontinuation procedures and notify the patients, 
appropriate regulatory authority, IRBs, and IECs. In terminating the study, Gilead and the 
investigator will ensure that adequate consideration is given to the protection of the patients’ 
interests.


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10.
REFERENCES
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antibody targeting of CD47 eliminates human acute lymphoblastic leukemia. 
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Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised 
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mutations influence survival in older patients with acute myeloid leukemia treated 
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international expert panel. Blood 2017;129 (4):424-47.
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phase 3 study of azacitidine vs conventional care regimens in older patients with 
newly diagnosed AML with >30% blasts. Blood 2015;126 (3):291-9.


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Edris B, Weiskopf K, Volkmer AK, Volkmer JP, Willingham SB, Contreras-Trujillo H, et al. 
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Feng D, Gip P, McKenna KM, Zhao F, Mata O, Choi TS, et al. Combination Treatment with 5F9 
and Azacitidine Enhances Phagocytic Elimination of Acute Myeloid Leukemia 
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Fesik SW. Promoting apoptosis as a strategy for cancer drug discovery. Nature reviews. Cancer 
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Freeman SD, Virgo P, Couzens S, Grimwade D, Russell N, Hills RK, et al. Prognostic relevance 
of treatment response measured by flow cytometric residual disease detection in 
older patients with acute myeloid leukemia. J Clin Oncol 2013;31 (32):4123-31.
Heuser M, Ofran Y, Boissel N, Brunet Mauri S, Craddock C, Janssen J, et al. Acute myeloid 
leukaemia in adult patients: ESMO Clinical Practice Guidelines for diagnosis, 
treatment and follow-up. Ann Oncol 2020;31 (6):697-712.
Hunter AM, Sallman DA. Current status and new treatment approaches in TP53 mutated AML. 
Best practice & research. Clinical haematology 2019;32 (2):134-44.
Jaiswal S, Jamieson CH, Pang WW, Park CY, Chao MP, Majeti R, et al. CD47 Is Up-Regulated 
on Circulating Hematopoietic Stem Cells and Leukemia Cells to Avoid 
Phagocytosis. Cell 2009;138 (2):271-85.
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement 
properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient 
groups: a multi-country study. Qual Life Res 2013;22 (7):1717-27.
Kadia TM, Jain P, Ravandi F, Garcia-Manero G, Andreef M, Takahashi K, et al. TP53 mutations 
in newly diagnosed Acute Myeloid Leukemia - Clinico-molecular characteristics, 
response to therapy, and outcomes. Cancer 2016;122 (22):3484-91.
Kim D, Wang J, Willingham SB, Martin R, Wernig G, Weissman IL. Anti-CD47 antibodies 
promote phagocytosis and inhibit the growth of human myeloma cells. Leukemia 
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Kim K, Maiti A, Kadia TM, Ravandi F, Daver N, Pemmaraju N, et al. 693 Outcomes of TP53-
Mutant Acute Myeloid Leukemia with Venetoclax and Decitabine. ASH 2020 
(62nd ASH Annual Meeting and Exposition):5.
Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, et al. Pre-Clinical Development of a 
Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLoS 
One. 2015a;10 (9):e0137345.
Liu X, Pu Y, Cron K, Deng L, Kline J, Frazier WA, et al. CD47 blockade triggers T cell-
mediated destruction of immunogenic tumors. Nat Med 2015b;21 (10):1209-15.
Majeti R, Chao MP, Alizadeh AA, Pang WW, Jaiswal S, Gibbs KD, Jr., et al. CD47 Is an 
Adverse Prognostic Factor and Therapeutic Antibody Target on Human Acute 
Myeloid Leukemia Stem Cells. Cell 2009;138 (2):286-99.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in 
Oncology (NCCN Guidelines®): Acute Myeloid Leukemia. Version 3.2020-23 
December 2019. 2020:
Platzbecker U, Middeke JM, Sockel K, Herbst R, Wolf D, Baldus CD, et al. Measurable residual 
disease-guided treatment with azacitidine to prevent haematological relapse in 
patients with myelodysplastic syndrome and acute myeloid leukaemia 
(RELAZA2): an open-label, multicentre, phase 2 trial. Lancet Oncol 2018;19 
(12):1668-79.
Rubin LG, Levin MJ, Ljungman P, Davies EG, Avery R, Tomblyn M, et al. 2013 IDSA clinical 
practice guideline for vaccination of the immunocompromised host. Clin Infect 
Dis 2014;58 (3):e44-100.
Rucker FG, Schlenk RF, Bullinger L, Kayser S, Teleanu V, Kett H, et al. TP53 alterations in 
acute myeloid leukemia with complex karyotype correlate with specific copy 
number alterations, monosomal karyotype, and dismal outcome. Blood 2012;119 
(9):2114-21.
Sallman DA, Ali NA, Yun S, Padron E, Song J, Hussaini MO, et al. Clonal Suppression of TP53 
Mutant MDS and Oligoblastic AML with Hypomethylating Agent Therapy 
Improves Overall Survival [Abstract]. Blood 2018;132 (Suppl 1):1817.
Sallman DA, Asch A, Al-Malki M, Lee D, Garcia-Manero G, Donnellan W, et al. Tolerability 
and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined 
With Azacitidine in MDS and AML Patients: Phase 1b Results [Presentation]. 
American Society of Clinical Oncology (ASCO) Annual Meeting Virtual; 2020a. 


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Sallman DA, Asch AS, Kambhampati S, Al Malki MM, Zeidner JF, Donnellan W, et al. The 
First-in-Class Anti-CD47 Antibody Magrolimab Combined With Azacitidine Is 
Well Tolerated and Effective in AML Patients: Phase 1b Results [Presentation]. 
62nd American Society of Hematology (ASH) Annual Meeting and Exposition 
Virtual; 2020b 05-08 December. 
Shoukier M, Konopleva M, Dinardo CD, Ravandi F, Andreeff M, Garcia-Manero G, et al. 
Activity of venetoclax-based therapy in TP53-mutated acute myeloid leukemia. J 
Clin Oncol 2019;37 (15).
Sievers EL, Lange BJ, Alonzo TA, Gerbing RB, Bernstein ID, Smith FO, et al. 
Immunophenotypic evidence of leukemia after induction therapy predicts relapse: 
results from a prospective Children's Cancer Group study of 252 patients with 
acute myeloid leukemia. Blood 2003;101 (9):3398-406.
Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, et al. First-in-Human, First-
in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With 
Advanced Cancers. J Clin Oncol 2019;37 (12):946-53.
Souers AJ, Leverson JD, Boghaert ER, Ackler SL, Catron ND, Chen J, et al. ABT-199, a potent 
and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. 
Nat Med 2013;19 (2):202-8.
Swartzman EE, Miraglia SJ, Mellentin-Michelotti J, Evangelista L, Yuan PM. A homogeneous 
and multiplexed immunoassay for high-throughput screening using fluorometric 
microvolume assay technology. Anal Biochem 1999;271 (2):143-51.
Troughton MC, Simmons LW, Langley C, Youssef M, Marques MB. A Novel Use of Human 
Platelet Concentrate to Resolve Interference of Anti-CD47 in Serologic Testing 
[IGT46]. Transfusion 2018;58 (S2):179A-80A.
Tseng D, Volkmer JP, Willingham SB, Contreras-Trujillo H, Fathman JW, Fernhoff NB, et al. 
Anti-CD47 antibody-mediated phagocytosis of cancer by macrophages primes an 
effective antitumor T-cell response. Proc Natl Acad Sci U S A 2013;110 
(27):11103-8.
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Evaluation and Research (CBER). Guidance for Industry: Drug-Induced Liver 
Injury: Premarketing Clinical Evaluation. July, 2009.
Velliquette RW, Aeschlimann J, Kirkegaard J, Shakarian G, Lomas-Francis C, Westhoff CM. 
Monoclonal anti-CD47 interference in red cell and platelet testing. Transfusion 
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VENCLEXTA, AbbVie Inc. VENCLEXTA® (venetoclax tablets), for oral use. U.S Prescribing 
Information. North Chicago, IL. Revised October. 2020:
VIDAZA, Celgene Corporation. VIDAZA® (azacitidine for injection), for subcutaneous or 
intravenous use. US Prescribing Information. Summit, NJ. Revised: September. 
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Willingham SB, Volkmer JP, Gentles AJ, Sahoo D, Dalerba P, Mitra SS, et al. The CD47-signal 
regulatory protein alpha (SIRPa) interaction is a therapeutic target for human 
solid tumors. Proc Natl Acad Sci U S A 2012;109 (17):6662-7.


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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Schedules of Assessment
Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 6.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria
Appendix 7.
European Organisation for the Research and Treatment of Cancer Quality of Life 
Questionnaire–Core Questionnaire (EORTC QLQ-C30)
Appendix 8.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
Appendix 9.
Patient Global Impression of Severity (PGIS) and Patient Global Impression of 
Change (PGIC)
Appendix 10.
Eastern Cooperative Oncology Group Performance Status
Appendix 11.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Appendix 12.
World Health Organization (WHO) Classification of AML
Appendix 13.
Amendment History


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Appendix 1.
Investigator Signature Page
GILEAD SCIENCES, INC.
333 LAKESIDE DRIVE
FOSTER CITY, CA 94404
STUDY ACKNOWLEDGMENT
A Phase 3, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in 
Combination with Azacitidine versus Physician’s Choice of Venetoclax in Combination with 
Azacitidine or Intensive Chemotherapy in Previously Untreated Patients with TP53 Mutant 
Acute Myeloid Leukemia
GS-US-546-5857 Protocol Amendment 5; 02 November 2023
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval.
[See appended electronic signature]
Medical Monitor
Signature
[See appended electronic signature]
Date
INVESTIGATOR STATEMENT
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated.
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study.
Principal Investigator Name (Printed)
Signature
Date
Site Number
PPD


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Appendix 2.
Schedules of Assessment
Table 20.
Schedule of Assessments – Screeninga
Study 
Assessment
Day −30 to −1
Bone marrow aspirate for central assessment of TP53 mutation statusb
X
Informed consenta
X
Demographics
X
Medical and cancer history
X
Serum pregnancy testc
X
CBC with differential, platelets, reticulocytes, blasts
X
Serum or plasma chemistry
X
PT, INR, and aPTT (or PTT)
X
Blood phenotyping or genotyping,f type, and screen (ABO/Rh), DAT
X
Urinalysis
X
Peripheral blood for MRD assessmentd
X
Bone marrow biopsy and aspirate for blast evaluation, correlative studies, cytogenetics, 
and MRD assessmentb,e
X
Peripheral blood smear (for blasts)e
X
ECOG performance status
X
Vital signs, height, and weight
X
Complete physical examination
X
HBV, HCV, and HIV
X
12-lead ECG (single)
X
Echocardiogram or MUGA (for patients appropriate for intensive therapy)
X
Adverse events related to protocol-mandated procedures
X
Prior and concomitant medications
X
Eligibility criteria
X
Randomization a 
X
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; aPTT = activated partial thromboplastin time; 
CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology 
Group; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency 
virus; MRD = minimal residual disease; MUGA = multigated acquisition (scan); PT/INR = prothrombin time/international 
normalized ratio; PTT = partial thromboplastin time; RBC = red blood cells; Rh = rhesus factor
a
Screening must be completed before randomization. Randomization must occur within 30 days of signing informed consent. 
The first dose of study treatment must be given within 72 hours after randomization.
b
Bone marrow biopsy and aspirate for blast evaluation, correlative studies, cytogenetics and to assess TP53 mutational status 
may take place as a prescreening assessment and will require an additional consent form. In that case, the MRD assessment 
will not be required.
c
Screening pregnancy test may be used as the Cycle 1 Day 1 test if performed within 72 hours prior to first dose; additional 
guidance is provided in Section 6.4.1. FSH test is required for female subjects who are < 54 years old who are not on 
hormonal contraception and who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian 
hormonal failure.
d
Peripheral blood sample for MRD assessment must be collected prior to the first dose of study treatment at the latest.


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e
A trephine (biopsy) is to be collected for baseline. This procedure must be performed prior to the first dose of study 
treatment at the latest. An aspirate sample will be collected for blast evaluation, MRD assessment, correlative studies, and 
biobanking. Bone marrow aspirate samples are to be obtained at the time of bone marrow (trephine) biopsy. Conventional 
cytogenetics to be tested per institutional standards. Peripheral blood smear for blasts are to be collected along with bone 
marrow aspirate/biopsy.
f
ABO/Rh type, antibody screen, DAT, and extended RBC phenotyping (including minor antigens such as CcDEe, Cw, 
MNSs, Kk, FyaFyb, and JkaJkb) must be performed for each patient. RBC genotyping instead of extended RBC 
phenotyping is acceptable for any patient. RBC genotyping (instead of an extended RBC phenotyping) must be performed if 
a patient received any RBC or whole blood transfusion within the previous 3 months (unless the laboratory has availability 
for special techniques for performing phenotyping for patients with a recent transfusion). Results must be available before 
the first dose of magrolimab.


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Table 21.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) and Venetoclax + Azacitidine 
Regimens
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8
11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8
15 22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
PRO Assessmentb
X
X
X
Serum or Urine Pregnancy 
Testc 
X
X
X
CBC with Differential, 
Platelets, Reticulocytes, 
Blastsd,e
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHd
X
X
X
X
X
Serum or Plasma 
Chemistryd
Xf Xf Xf Xf
X
X
X
X
X
X
X
Peripheral Blood Smear 
(for General 
Morphology)d,g
X
X
X
Peripheral Blood Smear 
(for Blasts)h
X
X
C4D28, 
C6D28 
then 
Q3C
Buccal Swabi
X


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Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8
11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8
15 22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Peripheral Blood Sample 
for Correlative Studiesj
X
X
X
Xk
X
C6D28
Peripheral Blood Sample 
for MRD Assessmenth
X
X
C4D28, 
C6D28 
then 
Q3C
Bone Marrow Aspirate for 
Cytogenetics, MRD 
Monitoring and Response 
Assessment,h,l,m
X
X
C4D28, 
C6D28 
then 
Q3C
Bone Marrow Aspirate 
and Biopsy for Correlative 
Studiesh
X
C6D28
Vital Signsn
X
X
X
X
X
X
X
X
X
X
X
X
Weightn
X
X
X
Symptom-directed 
Physical Examinationd
X
X
X
X
X
Adverse Events, 
Concomitant Medications 
(Including Blood 
Transfusions)o
X
X
X
X
X X X X
X
X
X
X
X
X X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
X


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 128
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Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8
11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8
15 22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Study Treatment Dispensing
Venetoclaxp
X
X
X
Study Treatment Administration
Azacitidineq
X
X
X
X
X X X
X
X X
X
X
X
X
X
X
X
X
X
X
X
Venetoclaxp,r
X
X
X
X
X X X X
X
X
X
X
X
X X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
X
C = cycle; CBC = complete blood count; D = day; EOT = end of treatment; EORTC QLQ- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire -Core 
Questionnaire; EQ-5D-5L = 5-level EuroQol 5 dimensions; LDH = lactate dehydrogenase; MRD = minimal residual disease; PGIC = Patient Global Impression of Change; PGIS = Patient Global 
Impression of Severity; PRO = patient-reported outcome; Q3C = every 3 cycles; WBC = white blood cell
a
If the patient is cytopenic at Day 28, CBC is to be monitored at least twice per week for 2 weeks or until optimal count recovery is reached (whichever comes first). The best CBC result within 
the ± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood count need not be repeated if the prior 
CBC (including prior Day 28 CBC) is within 3 days of Day 1.
b
Four PRO instruments will be administered in this study: the EORTC QLQ-C30 questionnaire, the EQ-5D-5L, the PGIS, and the PGIC. The patient should complete these questionnaires before 
any other study procedures at required visits. EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC. PGIC is not required at Cycle 1 Day 1.
c
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided in Section 6.4.1.
d
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for CBC, which must be performed within 
24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and 
within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
e
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to each magrolimab dose during Cycle 1.
f
To monitor the risk of tumor lysis syndrome during venetoclax ramp-up, blood chemistry is to be collected predose and 6 to 8 hours postdose of venetoclax administration on
Cycle 1 Day 1, Cycle 1 Day 2, and Cycle 1 Day 3. Blood chemistry on Cycle 1 Day 4 is to be collected 24 hours after the dose of venetoclax given on Cycle 1 Day 3.
g
Peripheral blood smears will be collected at predose and assessed locally.
h
Day 28 assessments can be done on Day 1 of the next cycle if there is no foreseen delay of more than 7 days. Bone marrow response information from Day 28 may be required to decide start of 
the next cycle per dosing modification guidelines in the protocol (Section 5.10, and Table 8, Table 9, and Table 11). Collection of bone marrow aspirate and biopsy for correlative studies will be 
allowed within 7 days (rather than a 3-day window).
i
Single sample will be collected on Day 1 or at any time during the study.
j
Samples will be collected predose within 12 hours prior to study treatment administration. 
I I I I I I I I I I I I I 
I I I I I I I I I I I I 
I I I I I I I I I 
1111 111111111 
I 111111111 I 
I 
11111111 
I 


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 129
02 November 2023
k
Peripheral blood samples for correlative studies do not need to be repeated at D1, if performed in the past 7 days. Collection of peripheral blood for correlative studies will be allowed within 
7 days (rather than a 3-day window).
l
Conventional cytogenetics to be tested per institutional standards.
m
An aspirate sample will be collected for response assessment and MRD assessment. Response assessments may be adjusted by up to 1 week prior to Cycle 1 Day 28, and Cycle 2 Day 28. After 
Cycle 2 Day 28, the window is up to 14 days ± from Day 28. Bone marrow results are to be reviewed as required for determining schedule modifications.
n
Vital signs will be assessed prior to infusion/injection of each study treatment on the days marked in the table. Weight will be assessed on Day 1 of each cycle. Details are provided in 
Section 6.4.5.
o
Collected at all regularly scheduled visits.
p
Venetoclax will be dispensed to the patient on Day 1 of each treatment cycle. 
q
Azacitidine administration should be completed at least 1 hour before magrolimab administration on days when both drugs are administered. Azacitidine may be administered on an alternative 
schedule such as Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive days. 
r
Venetoclax is administered daily. Please refer to Section 5.4.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
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02 November 2023
Table 22.
Magrolimab Administration and Associated Assessment Schedule-Treatment Period 
Visit Window (Days)
Nonea
± 3a
Day
1 
2
4 
8
11
15
Weekly  5 
Every 2 Weeks 
Vital signsb
X
X
X
X
X
X
X
Hemoglobinc
Pre and post dose
Pre and post dose
PK
Within 12 hours 
prior to 
magrolimab 
dosing
Antidrug antibodiese
Within 72 hours 
prior to 
magrolimab dosing
Within 12 hours prior 
to magrolimab dosing 
for 2nd weekly dose
Within 12 hours prior 
to magrolimab dosing 
before 1st, 5th, 9th, 
15th and 21st biweekly 
maintenance doses of 
30 mg/kgd
Magrolimab Administration
Premedication
X
X
X
X
Magrolimabg
X
X
X
X
X
X
X
ADA = antidrug antibodies; PK = pharmacokinetic(s)
a
In cases of magrolimab repriming/re-escalation following a treatment delay (Section 5.8.1), follow magrolimab schedule of assessment and administration for repriming Table 25. 
b
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.4.5.
c 
Hemoglobin must be performed within 24 hours prior to magrolimab dosing on Days 1 and 4 to ensure hemoglobin is ≥ 9 g/dL. Patients who do not meet these criteria must be transfused and 
have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 magrolimab doses. Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses of 
magrolimab during initial treatment (see Section 5.8).
d
On the first day of the biweekly maintenance dose, an additional sample for postdose PK will be collected at 1 hour (± 15 minutes) after the end of infusion of magrolimab.
e
When collected on the day of study treatment dosing, the blood sample for ADA must be collected at the same time as the predose PK sample. Antidrug antibodies will not be collected on Day 8.
f
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment and in case of reintroduction with repriming. Premedication for subsequent doses may 
be continued based on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions. In the case of a Grade 3 infusion related reaction, a premedication 
regimen for subsequent doses is required (Section 7.8.1.2).
g
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours (± 30 minutes) for infusions 
beyond the first 3 doses. Monitor patients for 1 hour post infusion for priming, repriming/re-escalation, and maintenance doses during the first 4 weeks. For magrolimab dosing, refer to Table 2.


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 131
02 November 2023
Table 23.
Schedule of Assessments - Treatment Period for the 7 + 3 Regimen
Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter Until 
Count Recovery 
or Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
PRO Assessmentc
X
X
Serum or urine Pregnancy 
Testd 
X
X
CBC with Differential, 
Platelets, Reticulocytes, 
Blastse,f
X
X
X
X
X
X
X
X
X
X
12-lead ECG (single)
Xg
Echocardiogram or 
MUGA 
Xg
Haptoglobin and LDHe
X
X
X
Serum or Plasma 
Chemistrye
X
X
X
X
X
X
X
X
Peripheral Blood Smear 
(for General 
Morphology)e,h
X
X
X
Peripheral Blood Smear 
(for Blasts)b, i
Xi
X
X
Buccal Swabk
X
Peripheral Blood Sample 
for Correlative Studiesl
X
Xj
X
Consolidation 
C4 only
Peripheral Blood Sample 
for MRD Assessmentb
 
Xj
X 
X


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 132
02 November 2023
Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter Until 
Count Recovery 
or Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
Bone Marrow Aspirate 
for Cytogenetics, MRD 
Monitoring and Response 
Assessmentb,i,m
Xj
X
X
Bone Marrow Aspirate 
and Biopsy for 
Correlative Studiesn
X
Consolidation 
C4 only
Vital Signso
X
X
X
X
X
X
X
X
X
X
X
X
X
Weighto
X
X
Symptom-Directed 
Physical Examinatione
X
X
X
X
X
X
Adverse Events, 
Concomitant Medications 
(Including Blood 
Transfusions)p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Study Treatment Administration
7 + 3
Daunorubicin or 
Idarubicinq
X
X
X
Cytarabiner
X
X
X
X
X
X
X
5 + 2
Daunorubicin or 
Idarubicinq
X
X
Cytarabiner
X
X
X
X
X
I I I I I I I I 
I I I I 
I I I I I I I I 
I I I I 


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 133
02 November 2023
Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter Until 
Count Recovery 
or Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
Consolidation
Cytarabine (HiDac)s
X
X
X
C = cycle; CBC = complete blood count; ECG = electrocardiogram; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 
Questionnaire; EQ-5D-5L = 5-level EuroQol 5 dimensions; LDH = lactate dehydrogenase; MRD = minimal residual disease; MUGA = multigated acquisition (scan); PGIC = Patient Global 
Impression of Change; PGIS = Patient Global Impression of Severity; PRO = patient-reported outcome; WBC = white blood cell
a
± 3-day visit window does not apply to specimen collection during induction for correlative studies, nor to study drug administration.
b
Response assessments will be performed as described in Table 13.
c
Four PRO instruments will be administered in this study: the EORTC QLQ-C30 questionnaire, the EQ-5D-5L, the PGIS, and the PGIC. The patient should complete these questionnaires before 
any other study procedures at required visits. EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC. PGIC is not required at Cycle 1 Day 1. 
d
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided in Section 6.4.1.
e
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment; thereafter, pretreatment assessments are to be 
collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
f
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to initiation of study treatment.
g
At the end of Consolidation Cycles 1 and 4.
h
Peripheral blood smears will be collected at predose and assessed locally.
i 
A bone marrow sample is to be collected for response assessment. An aspirate sample will be collected for response assessment and MRD assessment. Response assessments may be adjusted by 
± 5 days for Cycle 1 (Day 15). The window for post consolidation or post transplantation is ± 14 days. 
j
Response assessment (including bone marrow biopsy/aspirate) at C1D15 should be performed only after 7 + 3 induction to determine if second induction with 5 + 2 is needed. After 5 + 2 
induction, there is no need to perform Day 15 bone marrow assessment and bone marrow assessment should be performed only at count recovery (not beyond 42 days after the initiation of 5 + 2).
k
Single sample to be collected on Day 1 of the first induction cycles or at any time during the study.
l
Samples will be collected predose within 12 hours prior to study treatment administration. Collection of peripheral blood for correlative studies will be allowed within 7 days (rather than a 3-day 
window).
m
Conventional cytogenetics to be tested per institutional standards.
n
Collection of bone marrow aspirate and biopsy for correlative studies will be allowed within 7 days (rather than a 3-day window).
o
Vital signs will be assessed prior to infusion of each study treatment. Weight will be assessed on Day 1 of each cycle. Details are provided in Section 6.4.5.
p
Collected at all regularly scheduled visits.
q
For 7 + 3 regimen, daunorubicin or idarubicin is administered on Days 1-3 and for 5 + 2 regimen, daunorubicin or idarubicin is administered on Days 1 and 2.
r
For 7 + 3 regimen, cytarabine is administered on Days 1-7 and for 5 + 2 regimen, cytarabine is administered on Days 1-5.
s
Cytarabine (HiDAC) is administered every 12 hours in the consolidation cycles.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
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Table 24.
Schedule of Assessments – Post treatment
End of Treatment Visit
Safety Follow-up 
Visit/Call
(Telephone)a
Safety Follow-up 
Visit/Call
(Telephone)a
Long -term 
Follow-up
Long-term Follow-up 
After SCT
Survival 
Follow-up
Within 7 Days After 
Last Dose or EOT 
Decision, Whichever 
Occurs Later
30 Days
After Last Dose
70 Days
After Last Doseb
Until Disease 
Progression or Start 
of New Anti-AML 
Therapyc, 
Whichever Occurs 
Firstd
Until Disease 
Progressionb or Start 
of a New Anti-AML 
Therapyc, Whichever 
Occurs Firstd
Every 2 
Months Until 
Death or End 
of Study
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 Days 
± 14 days
Serum or Urine Pregnancy Teste
Q4W
CBC with Differential, Platelet Count, 
Reticulocytes, Blasts
X
Q12W
Q12W
Serum or Plasma Chemistry
X
Peripheral Blood for Correlative Studiesf
X
Pharmacokinetics
X
Antidrug Antibodies 
X
Bone Marrow Aspiratei for MRD Monitoring, 
Response Assessmentg, and Cytogeneticsh
Xi
Q12W
Q12W
Peripheral Blood Smear (for Blasts)g
Xe
Q12W
Q12W
12-lead ECG (single) (for patients treated with 7 + 3)j
X
Q12W
Q12W
Echocardiogram or MUGA (for patients treated with 
7 + 3)j
X
Q12W
Q12W
ECOG performance status
X
Vital Signs 
X
Symptom-Directed Physical Examination
X
PRO Assessmentk
X
Q12W
Adverse Eventsl
X
X
X
Concomitant Medications
X
X
X
New Anti-AML Therapym
X
X
X
X
X
X
Survival Follow-up
X


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
Page 135
02 November 2023
AE = adverse event; CBC = complete blood count; CR = complete remission; CRh = complete remission with partial hematologic recovery; CRi = complete remission with incomplete count 
recovery; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core Questionnaire; EOT = end of treatment; MLFS = morphologic leukemia-free state; MUGA = multigated acquisition (scan); PGIS/PGIC = Patient Global Impression of 
Severity/Patient Global Impression of Change; PR = partial remission; PRO = Patient Report Outcome; Q4W = every 4 weeks; Q12W = every 12 weeks; SAE = serious adverse event; SCT = stem 
cell transplant; SOC = standard of care
a
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site.
b
For patients who do not initiate new anti-AML therapy after the last dose. See Section 6.4.11. for adverse event reporting details.
c
For patients who start new anti-AML therapy (other than SCT) before a relapse, efficacy status (done as SOC) will be collected until relapse. 
d
Disease progression includes relapse after CR/CRi/CRh or disease progression after PR, stable disease, or MLFS.
e
Pregnancy tests should be taken at monthly intervals until end of contraception requirement.
f
Peripheral blood for correlative studies should not be repeated at EOT if done at the end of the Consolidation Cycle 4.
g
Response assessment at EOT is required at last dose or EOT decision (± 14 days) and is not required if performed within the last 30 days or if progressive disease has been documented or start of new anti-
AML therapy, whichever comes first. (SCT and maintenance therapy are not considered new anti-AML therapy.) 
h
Conventional cytogenetic testing (per institutional standards) is required for all patients.
i
Bone marrow aspirate and biopsy for correlative studies is required at EOT if not done at the end of the Consolidation Cycle 4.
j
Only for patients undergoing treatment with 7 + 3 intensive chemotherapy. ECG and echocardiogram/MUGA should not be repeated at EOT visit if performed in the past 4 weeks.
k
EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC.
l
Report all AEs through the safety follow-up visit/call, and any treatment-related SAEs thereafter.
m
Collect data for the first new anti-AML therapy following the last dose of study treatment.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 5
CONFIDENTIAL
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02 November 2023
Table 25.
Schedule of Assessments - Repriming/Reescalation Cycle (Required after Magrolimab Delays of > 4 Weeks)
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 2 weeks 
OR
57, then every 2 weeksb
Safety
CBC with differential, 
platelets, reticulocytesc,d
X
X
X
X
X
X
X
Haptoglobin and LDHc
X
X
X
X
Chemistryc
X
X
X
X
X
Peripheral blood smear for 
general morphologyc,e
X
X
X
Vital signsf
X
X
X
X
X
X
X
Weight
X
Symptom-directed physical 
examinationc
X
X
X
Adverse eventsg
Concomitant medicationsg
PK/Immunogenicity
PKj
X
X
Xj
Xj
Antidrug antibodiesk
X
Xk
Xk
Magrolimab Administration
Premedicationl
X
X
X
X
Magrolimabm
X
X
X
X
X
X
X
ADA = antidrug antibodies; CBC = complete blood count; EOT = end of treatment; LDH = lactate dehydrogenase; PK = pharmacokinetic(s); Q4W = every 4 weeks; WBC = white blood cell
a
Any other visit window specifications for individual assessments should be applied.
b
In case the repriming occurs during the first 4 weeks of magrolimab treatment, patient should receive magrolimab 30 mg/kg weekly × 5 after receiving Day 15 dose. All Day 22 safety assessments should be 
completed weekly x 5. One week after the 5th weekly dose, dosing of magrolimab will be 30 mg/kg Q2W.
c
Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of any study treatment. Pretreatment laboratory assessments are to be collected within 24 hours 
prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
d
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during first 4 weeks of repriming. In 
the case of repriming, before the administration of the 2 first doses of magrolimab, hemoglobin should be ≥ 9 g/dL. Transfusions are allowed to meet this hemoglobin level.
e
Peripheral blood smears for general morphology will be collected predose and assessed locally.


Magrolimab
Protocol GS-US-546-5857
Final
Gilead Sciences, Inc.
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CONFIDENTIAL
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02 November 2023
f
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.4.5.
g
Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are not scheduled.
j
Samples will be collected within 72 hours before the first dose of magrolimab and within 12 hours before subsequent doses of magrolimab. In addition to Day 1, and Day 8, predose samples will 
also be collected before the Day 29 dose (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the 1st, 5th, 9th, 15th, and 21st biweekly 
maintenance doses of 30 mg/kg, respectively, and at EOT. On the first day of the biweekly maintenance dose, an additional sample for postdose PK will be collected at 1 hour (± 15 minutes) 
after the end of infusion of magrolimab.
k
When collected on the day of magrolimab dosing, the blood sample for ADA must be collected at the same time as the predose PK sample. ADA samples will be collected at predose on Day 1 
and Day 29 (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the 1st, 5th, 9th, 15th and 21st biweekly maintenance doses of 30 mg/kg, 
respectively, and at EOT.
l
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedication for subsequent cycles may be 
continued based on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions. In the case of a Grade 3 infusion related reaction, a premedication 
regimen for subsequent doses is required (Section 7.8.1.2).
m
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses, and then 2 hours (± 30 minutes) for infusions beyond the first 
3 doses. Monitor patients for 1 hour post infusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to Table 2.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 5
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Table 26.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) and Venetoclax + Azacitidine 
Regimens, in the Event the Study Meets Futility, and the Sponsor Decides to Terminate the Study
Visit Window
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8
11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8
15 22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Serum or Urine Pregnancy 
Testb,
X
X
X
CBC with Differential, 
Platelets, Reticulocytes, 
Blastsc, d
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum or Plasma 
Chemistrye
Xe Xe Xe Xe
X
X
X
X
X
X
X
Bone Marrow Aspirate for 
Response Assessment,f, g, h
X
X
C4D28, 
C6D28 
then 
Q3C
Vital Signsi
X
X
X
X
X
X
X
X
X
X
X
X
Weighti
X
X
X
Symptom-directed 
Physical Examinationc
X
X
X
X
X
Adverse Events, 
Concomitant Medications 
(Including Blood 
Transfusions)j
X
X
X
X
X X X X
X
X
X
X
X
X X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
X


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Visit Window
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8
11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8
15 22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Study Treatment Dispensing
Venetoclaxk
X
X
X
Study Treatment Administration
Azacitidinel
X
X
X
X
X X X
X
X X
X
X
X
X
X
X
X
X
X
X
X
Venetoclaxk, m
X
X
X
X
X X X X
X
X
X
X
X
X X
X
X
X
X X
X
X
X
X
X
X
X
X
X
X
X
X
C = cycle; CBC = complete blood count; D = day; MRD = minimal residual disease; Q3C = every 3 cycles; SOC = standard of care; WBC = white blood cell
a.
If the patient is cytopenic at Day 28, CBC is to be monitored at least twice per week for 2 weeks or until optimal count recovery is reached (whichever comes first). The best CBC result within 
the ± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood count need not be repeated if the prior 
CBC (including prior Day 28 CBC) is within 3 days of Day 1.
b.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided in Section 6.4.1.
c.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for CBC, which must be performed within 
24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and 
within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
d.
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to each magrolimab dose during Cycle 1.
e.
To monitor the risk of tumor lysis syndrome during venetoclax ramp-up, blood chemistry is to be collected predose and 6 to 8 hours postdose of venetoclax administration on Cycle 1 Day 1, 
Cycle 1 Day 2, and Cycle 1 Day 3. Blood chemistry on Cycle 1 Day 4 is to be collected 24 hours after the dose of venetoclax given on Cycle 1 Day 3.
f.
Bone marrow assessments may continue locally as per the schedule outlined in Table 13 and Table 26 or as per investigator discretion. MRD testing will not be required nor performed by the 
central laboratory but may be done locally per SOC. If continuing response assessments per Table 13 and Table 26, Day 28 assessments can be done on Day 1 of the next cycle if there is no 
foreseen delay of more than 7 days. Bone marrow response information from Day 28 may be used to decide start of the next cycle per dosing modification guidelines in the protocol 
(Section 5.10, and Table 8, Table 9, and Table 11).
g.
Conventional cytogenetics testing may be performed locally per SOC but will not be required. 
h.
If continuing assessments per Table 13 and Table 26, response assessments may be adjusted by up to 1 week prior to Cycle 1 Day 28, and Cycle 2 Day 28. After Cycle 2 Day 28, the window is 
up to 14 days ± from Day 28. Bone marrow results should be reviewed as required for determining schedule modifications.
i.
Vital signs will be assessed prior to infusion/injection of each study treatment on the days marked in the table. Weight will be assessed on Day 1 of each cycle. Details are provided in 
Section 6.4.5.
I I I I I I I I I I I I I 
I I I I I I I I I I I I 
I I I I I I I I I 
1111 111111111 
1111111111 I 
I 
11111111 
I 


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j.
Collected at all regularly scheduled visits. In the event the study meets futility, and the sponsor decides to terminate the study, AEs that occur following initiation of study medication, regardless 
of cause or relationship, will be collected until 30 days (± 7 days) after last administration of study drug and reported on the eCRFs as instructed.
k.
Venetoclax will be dispensed to the patient on Day 1 of each treatment cycle.
l.
Azacitidine administration should be completed at least 1 hour before magrolimab administration on days when both drugs are administered. Azacitidine may be administered on an alternative 
schedule such as Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive days. 
m.
Venetoclax is administered daily. Please refer to Section 5.4.


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Table 27.
Magrolimab Administration and Associated Assessment Schedule-Treatment Period, in the Event the Study Meets 
Futility, and the Sponsor Decides to Terminate the Study 
Visit Window (Days)
Nonea
± 3a
Day
1 
2
4 
8
11
15
Weekly  5 
Every 2 Weeks 
Vital signsb
X
X
X
X
X
X
X
Hemoglobinc
Pre and post dose
Pre and post dose
Magrolimab Administration
Premedicationd
X
X
X
X
Magrolimabe
X
X
X
X
X
X
X
a.
In cases of magrolimab repriming/re-escalation following a treatment delay (Section 5.8.1), follow magrolimab schedule of assessment and administration for repriming (Table 29). 
b.
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.4.5.
c.
Hemoglobin must be performed within 24 hours prior to magrolimab dosing on Days 1 and 4 to ensure hemoglobin is ≥ 9 g/dL. Patients who do not meet these criteria must be transfused and 
have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 magrolimab doses. Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses of 
magrolimab during initial treatment (see Section 5.8).
d.
Premedication is required prior to the administration of the first 4 doses of magrolimab and in case of reintroduction with repriming. Premedications should include oral acetaminophen 650 to 
1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg or comparable regimen. For patients who do not experience an IRR with the first 2 doses of magrolimab, 
steroid pretreatment can be discontinued at investigators’ discretion. Patients who experience IRRs with the first 2 doses of magrolimab should continue premedication with corticosteroids prior 
to subsequent doses at the investigator’s discretion. (Sections 5.9 and 7.8.1.2).
e.
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours (± 30 minutes) for infusions 
beyond the first 3 doses. Monitor patients for 1 hour post infusion for priming, repriming/re-escalation, and maintenance doses during the first 4 weeks. For magrolimab dosing, refer to Table 2.


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Table 28.
Schedule of Assessments – Posttreatment, in the Event the Study Meets Futility, and the Sponsor Decides to Terminate 
the Study
End of Treatment Visit
Safety Follow-up Visit/Call
(Telephone)
Within 7 Days After Last Dose or EOT Decision, 
Whichever Occurs Later
30 Days
After Last Dose
Visit Window
± 7 Days
± 7 Days
Serum or Urine Pregnancy Testa
Q4W
CBC with Differential, Platelet Count, 
Reticulocytes, Blasts
X
Serum or Plasma Chemistry
X
Bone Marrow Aspirate for Response Assessmentb, c
X
ECOG performance status
X
Vital Signs 
X
Symptom-Directed Physical Examination
X
Adverse Eventsd, e
X
X
Concomitant Medications
X
X
AE = adverse event; CBC = complete blood count; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; MRD = minimal residual disease; Q4W = every 4 weeks; SAE = serious 
adverse event; SCT = stem cell transplant; SOC = standard of care
a.
Pregnancy tests should be taken at monthly intervals until end of contraception requirement (Appendix 5).
b.
Response assessment at EOT may be performed locally at last dose or EOT decision (± 14 days). MRD testing will not be required nor performed by the central laboratory but may be done locally per 
SOC.
c.
Conventional cytogenetic testing may be performed per SOC but is not required.
d.
Report all AEs through the safety follow-up visit/call. SAEs that occur after the 30 days (± 7 days) posttreatment follow-up visit may be reported if deemed relevant to the use of study drug by 
the investigator. Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are 
not scheduled. In the event the study meets futility and the sponsor decides to terminate the study, AEs and concomitant medications will be collected until 30 days (± 7 days) after last 
administration of study drug and reported on eCRFs as instructed. Post-study anti-AML therapy status will not be collected for patients discontinuing study treatment in the event of study 
termination due to futility.
e.
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site. In the event the study meets futility, and the sponsor decides 
to terminate the study, SAEs that occur after the 30 days (± 7 days) posttreatment follow-up visit may be reported if deemed relevant to the use of study drug by the investigator.


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Table 29.
Schedule of Assessments - Repriming/Re-escalation Cycle (Required after Magrolimab Delays of > 4 Weeks), in the 
Event the Study Meets Futility, and the Sponsor Decides to Terminate the Study
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 2 weeks 
OR
57, then every 2 weeksb
Safety
CBC with differential, 
platelets, 
reticulocytesc,d
X
X
X
X
X
X
X
Chemistryc
X
X
X
X
X
Vital signse
X
X
X
X
X
X
X
Weight
X
Symptom-directed 
physical examinationc
X
X
X
Adverse eventsf
Concomitant 
medicationsf
Magrolimab Administration
Premedicationg
X
X
X
X
Magrolimabh
X
X
X
X
X
X
X
CBC = complete blood count; Q2W = every 2 weeks; WBC = white blood cell
a.
Any other visit window specifications for individual assessments should be applied.
b.
In case the repriming occurs during the first 4 weeks of magrolimab treatment, patient should receive magrolimab 30 mg/kg weekly × 5 after receiving Day 15 dose. All Day 22 safety assessments should be 
completed weekly × 5. One week after the 5th weekly dose, dosing of magrolimab will be 30 mg/kg Q2W.
c.
Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of any study treatment. Pretreatment laboratory assessments are to be collected within 24 hours 
prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
d.
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during first 4 weeks of repriming. In 
the case of repriming, before the administration of the 2 first doses of magrolimab, hemoglobin should be ≥ 9 g/dL. Transfusions are allowed to meet this hemoglobin level.
e.
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Section 6.4.5.


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f.
Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are not scheduled. In 
the event the study meets futility, and the sponsor decides to terminate the study, AEs and concomitant medications will be collected until 30 days (± 7 days) after last administration of study 
drug and reported on eCRFs as instructed. Post-study anti-AML therapy status will not be collected for patients discontinuing study treatment in the event of study termination due to futility.
g.
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedications should include oral 
acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg or comparable regimen. For patients who do not experience an IRR with the first 
2 doses of magrolimab, steroid pretreatment can be discontinued at investigators’ discretion. Patients who experience IRRs with the first 2 doses of magrolimab should continue premedication 
with corticosteroids prior to subsequence doses at the investigator’s discretion (Sections 5.9 and 7.8.1.2).
h.
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses, and then 2 hours (± 30 minutes) for infusions beyond the first 
3 doses. Monitor patients for 1 hour post infusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to Table 2.


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Appendix 3.
Pandemic Risk Assessment and Mitigation Plan
During an ongoing pandemic, potential risks associated with patients being unable to attend 
study visits have been identified for this study. 
These potential risks and mitigation plans can be summarized as follows:
1) Schedule of assessments:
a) Physical examination:
i)
For all assessments where a physical examination is indicated, this portion of the visit 
can be conducted virtually; however, when samples need to be collected or dosing 
performed, these activities must occur in the clinic.
ii) If a virtual visit is conducted for the physical examination assessment portion, in 
order to limit a patient’s time in the clinic, vital signs may be omitted.
b) Dosing:
i)
For Cycle 2 and repriming cycles, magrolimab can be administered on Day 7 with 
azacitidine, with collection of Day 8 assessments (ie, laboratory assessments, PK) on 
Day 7 in order to minimize an extra patient visit.
ii) Dosing delays with magrolimab:
(1) For patients who may have travel restrictions, the 4-week period of magrolimab 
dose delay for repriming can be extended to 6 weeks in order to minimize the 
need for repriming for patients in this scenario. Medical monitor approval is 
needed for this specific situation. Magrolimab every-2-week dosing should be 
encouraged as dosing intervals longer than this will lead to suboptimal efficacy.
iii) Dosing with azacitidine:
(1) If needed under specific circumstances, sites can allow for administration of 
azacitidine locally nearer to patient’s residence, with proper documentation (eg, 
name of site, name of physician overseeing transfusion, name of laboratory used, 
including accreditation certificate). Administration of azacitidine outside the 
center should be reserved only in cases where patients will not be able to get 
azacitidine dosing otherwise.
(2) If treatment administration is given locally, then the patient should be evaluated 
by a local hematologist on Day 1 of that treatment cycle and have all laboratory 
assessments required on the Day 1 treatment cycle performed as per the protocol. 
The site should procure the clinical notes and laboratory reports for the principal 
investigator (PI) review and signature. The site is to ensure that all of these 
documents are filed in the patient’s source records.


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(3) The treating physician at the study site should speak to the local hematologist and 
review protocol guidelines/dosing of azacitidine/reporting of reactions and 
document this information in the medical records.
c) Sample collection:
i)
While it is preferred to collect all protocol-specified laboratory samples, if resources 
are limited, PK/ADA samples may be collected and stored (frozen) and not shipped in 
real-time if staff are not available to do so.
ii) MRD testing should be collected and shipped in real-time.
iii) For correlative peripheral blood or bone marrow aspirate samples, if they cannot be 
shipped according to their corresponding standard procedures same day, or 
refrigerated overnight for shipment the next day, please isolate the mononuclear cells 
(eg, by Ficoll gradient) and cryopreserve according to local best practices. If it is not 
possible to either ship samples or preserve and store according to the guidance above, 
then collection of these samples may be omitted until normal operations can resume.
d) General patient selection guidance:
i)
To minimize patients receiving RBC transfusions given the current transfusion 
product shortage, we recommend selecting patients with higher hemoglobin 
thresholds at baseline and use IV iron and/or erythropoietin where clinically 
indicated.
2) Study drug supplies to patients and sites:
a) Patients may be unable to return to the site for a number of visits to get the study drug, or 
the site may be unable to accept any patient visits. Without study drugs, the patient would 
not be able to stay on the study drug as planned per protocol.
Mitigation plan: If permitted by local EC/IRB/Regulatory authority as applicable and 
with sponsor’s approval, study drug supplies may be provided to the patient from the site 
without a clinic visit. It must be confirmed that the patient may safely continue on study 
drug as determined by the PI. A virtual study visit, via phone or video conferencing, must 
be performed prior to remote study drug resupply. At the earliest opportunity, the site will 
schedule in-person patient visits and return to the protocol’s regular schedule of 
assessments. A qualified courier may be utilized to ship the study drug from sites to study 
patients, and a qualified vendor may be utilized to perform infusions in the patients’ local 
vicinity.
b) Shipments of study drug from the sponsor to the investigational site could be delayed 
because of transportation issues. Without study drug, the patient would not be able to stay 
on the study drug as planned per protocol.


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Mitigation plan: The sites’ study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate if they foresee shortage in study drug inventory or if 
there is any interruption in local shipping service. The sponsor will continue to monitor 
inventory at the study drug depot and study sites. Manual shipments will be triggered, as 
necessary.
3) Patient safety monitoring and follow-up:
a) Patients may be unable or unwilling to come to the study site for their scheduled study 
visits as required per protocol.
Mitigation plan: For patients who may be unable or unwilling to visit the study site for 
their scheduled study visits as required per protocol, the PI or qualified delegate will 
conduct a virtual study visit, via phone or video conferencing, to assess the patient within 
target visit window date whenever possible. During the virtual study visit, the following 
information at minimum will be reviewed:
i)
Confirm if patient has experienced any adverse events (AEs)/serious adverse events 
(SAEs)/special situations (including pregnancy) and follow-up on any unresolved 
AE/SAEs
ii) Review current list of concomitant medications and document any new concomitant 
medications
iii) If applicable, confirm patient’s study drug supply is sufficient to last until the next 
planned visit date. If study drug resupply is needed it will be provided as described 
above in (2)
iv) If applicable, confirm that electronic diary questionnaires and patient-reported 
outcomes have been completed and transmitted.
v) If applicable, remind patient to maintain current dosing and to keep all dispensed 
study drug kits for return at the next on-site visit
b) Patients may be unable or unwilling to travel to the site for planned assessments 
(eg, safety blood draws); hence, samples may not be sent for central lab analyses.
Mitigation plan: Accredited local laboratory may be utilized as appropriate to monitor 
patient safety until the patient can return to the site for their regular follow-up per 
protocol. Any laboratory assessments conducted at a local laboratory due to the pandemic 
will be documented accordingly. Pregnancy testing may be performed using a home urine 
pregnancy test if local laboratory pregnancy testing is not feasible. Alternative sample 
handling and storage may be possible for samples routinely sent to the central laboratory; 
sites should refer to the study laboratory manual and discuss with the sponsor for further 
guidance.


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c) Patients may be unable or unwilling to attend the study visit to sign an updated ICF 
version if there is an update.
Mitigation plan: The site staff will follow their approved consent process and remain in 
compliance with local EC/IRB and national laws and regulations. Remote consent will be 
allowed if it has been approved by the local EC/IRB. The consent process will be 
documented and confirmed by normal consent procedure at the earliest opportunity.
d) The safety of study participants is important and testing of COVID-19 infection will be 
based on local clinical guidelines for testing based on signs/symptoms and or suspected 
exposure to COVID-19.
Mitigation plan: If patient has a diagnosis of COVID-19 while on this clinical study, 
study drugs may be held until clinical improvement or resolution in accordance with the 
treating physician’s judgment and general magrolimab/azacitidine dose delay guidance in 
the protocol. Additional supportive care and treatment measures for COVID-19 infection 
on the study will be performed in accordance with local institutional guidelines. Patients 
with a COVID-19 infection while participating in a clinical study will have this event 
documented as an adverse event in the clinical database.
4) Protocol and monitoring compliance:
a) Protocol deviations may occur if scheduled visits cannot occur as planned per protocol.
Mitigation plan: If it is not possible to complete a required procedure, an unscheduled 
visit should be conducted as soon as possible when conditions allow. The situation should 
be recorded and explained as a protocol deviation. Any missed patient visits or deviation 
to the protocol due to the pandemic must be reported in the eCRF and described in the 
clinical study report. Any virtual study visits that are conducted in lieu of clinic visits due 
to the pandemic will be documented as a protocol deviation related to the pandemic.
b) Monitors may be unable to carry out source data review or source data verification 
(SDV), or study drug accountability or assess protocol and GCP compliance. This may 
lead to delays in SDV, an increase in protocol deviations, or under reporting of AEs.
Mitigation plan: The study monitor is to remain in close communication with the site to 
ensure data entry and query resolution. The study monitor is to reference the Study 
Monitoring Plan for guidance on how to conduct a remote monitoring visit. The study 
staff is to save and document all relevant communication in the study files. The status of 
sites that cannot accept monitoring visits and/or patients on site, must be tracked centrally 
and updated on a regular basis.


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5) Missing data and data integrity:
a) There may be an increased amount of missing data due to patients missing 
visits/assessments. This could have an impact on the analysis and the interpretation of 
clinical study data.
Mitigation plan: Implications of a pandemic on methodological aspects for the study will 
be thoroughly assessed and documented, and relevant actions will be taken as appropriate 
(ie, modification of the statistical analysis plan) and in compliance with regulatory 
authorities’ guidance. Overall, the clinical study report will describe the impact of the 
pandemic on the interpretability of study data.
Risks will be assessed continuously, and temporary measures will be implemented to mitigate 
these risks as part of a mitigation plan, as described above. These measures will be 
communicated to the relevant stakeholders as appropriate and are intended to provide alternate 
methods that will ensure the evaluation and assessment of the safety of patients who are enrolled 
in this study.
Since these potential risks are considered mitigated with the implementation of these measures, 
the expected benefit-risk assessment of the study drugs in study patients remains unchanged. In 
the event that these potential risks cannot be mitigated due to the escalation of a pandemic, 
randomization of new patients will be placed on hold until the pandemic outbreak is under 
control by following local regulatory guidelines.


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Appendix 4.
Toxicity Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_R 
eference_8.5x11.pdf


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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a. Definition of Childbearing Potential
For the purposes of this study, a female born patient is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming postmenopausal, unless the 
patient is permanently sterile or has medically documented ovarian failure.
Women are considered to be in a postmenopausal state when they are ≥ 54 years of age with 
cessation of previously occurring menses for ≥ 12 months without an alternative cause. In 
addition, women of any age with amenorrhea of ≥ 12 months may also be considered 
postmenopausal if their follicle-stimulating hormone (FSH) level is in the postmenopausal range 
and they are not using hormonal contraception or hormonal replacement therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female patient of any age.
b. Definition of Male Fertility
For the purposes of this study, a male born patient is considered fertile after the initiation of 
puberty unless the patient is permanently sterile by bilateral orchidectomy or medical 
documentation.
2) Contraception Requirements for Female Subjects
a. Study Drug Effects on Pregnancy and Hormonal Contraception
There are no adequate and well-controlled studies of magrolimab in pregnant women. 
Magrolimab when dosed to pregnant monkeys was not teratogenic, but high-dose magrolimab 
resulted in stillbirth and neonate deaths, secondary to fetal anemia. Based on these data, 
magrolimab should not administered to pregnant women. Advise females with reproductive 
potential to avoid pregnancy during treatment with magrolimab and for at least 3 months after 
treatment.
For magrolimab, there is no anticipated PK interaction with progestin or other steroids based on 
the distinct clearance pathways.
Based on the MOA and findings in animals, azacitidine may cause fetal harm when administered 
to a pregnant woman. Advise women of childbearing potential to avoid pregnancy during 
treatment with azacitidine. Duration of required contraception for female patients in this clinical 
study should start from screening visit until 6 months after the last dose of the latest administered 
study drug. Studies in vitro have demonstrated that CYP enzyme induction or inhibition by 
azacitidine at clinically achievable plasma concentrations is unlikely.


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Based on its MOA and findings in animals, venetoclax may cause embryo-fetal harm when 
administered to a pregnant woman. Advise women of childbearing potential to avoid pregnancy 
during treatment with venetoclax. Duration of required contraception for female patients in this 
clinical study should start from screening visit until 6 months after the last dose of the latest 
administered study drug.It is currently unknown whether venetoclax may reduce the 
effectiveness of hormonal contraceptives.
Cytarabine can cause fetal harm when administered to a pregnant woman. Women of 
childbearing potential should be advised to avoid becoming pregnant.
Daunorubicin crosses the placenta and experiments in animals have shown it to be mutagenic, 
carcinogenic, and teratogenic. Women of childbearing potential should be advised to avoid 
becoming pregnant. For women who want to become pregnant after completing daunorubicin 
treatment, genetic counselling is also recommended.
The embryotoxic potential of idarubicin has been demonstrated in both in vitro and in vivo 
studies. There is no conclusive information about idarubicin adversely affecting human fertility 
or causing teratogenesis. The patient should be informed of the potential hazard to the fetus. 
Patients desiring to have children after completion of therapy should be advised to obtain genetic 
counselling first if appropriate and available.
Refer to the latest version of the magrolimab IB for additional information. Refer to the regional 
prescribing information for information on the potential risks of treatment with azacitidine, 
venetoclax, cytarabine, daunorubicin, or idarubicin.
b. Contraception Requirements for Female Patients of Childbearing Potential
The inclusion of female patients of childbearing potential requires the use of highly effective 
contraceptive measures with a failure rate of < 1% per year. They must have a negative serum 
pregnancy test at screening and a negative pregnancy test is required prior to study treatment 
administration on Cycle 1 Day 1. Pregnancy tests will be performed at the beginning of each 
cycle thereafter (described in the protocol) until the end of contraception requirement.
Duration of required contraception for female patients in this clinical study should start from 
screening visit until 6 months after the last dose of the latest administered study drug.
Female patients must agree to one of the following contraceptive methods:
Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the subject’s preferred and usual lifestyle.
Or
Consistent and correct use of 1 of the following methods of birth control listed below:
•
Non-hormonal intrauterine device (IUD)
•
Hormonal IUD (must be used in conjunction with a barrier method)


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•
Bilateral tubal occlusion (upon medical assessment of surgical success)
•
Vasectomy in the male partner (upon medical assessment of surgical success)
Or
Female patients who wish to use a hormonally based method must use it in conjunction with a 
barrier method, preferably a male condom. Hormonal methods are restricted to those associated 
with the inhibition of ovulation. Hormonally based contraceptives and barrier methods permitted 
for use in this protocol are as follows, where local standard of care practices allow:
•
Hormonal methods (each method must be used with a barrier method, preferably male 
condom)
Oral contraceptives (either combined or progesterone only)
Injectable progesterone*
Transdermal contraceptive patch*
Contraceptive vaginal ring*
Subdermal contraceptive implant*
•
Barrier methods (each method must be used with a hormonal method)
Male condom (with or without spermicide)
Female condom (with or without spermicide)*
Diaphragm with spermicide*
Cervical cap with spermicide*
Sponge with spermicide*
Inclusion of methods of contraception in this list of permitted methods does not imply that the 
method is approved in any country or region. Methods should only be used if locally approved.
Female patients must also refrain from egg donation, cryopreservation of cells, and in vitro 
fertilization during treatment and until the end of contraception requirement. If needed, female 
patients should be advised to seek advice about egg donation and cryopreservation prior to 
treatment.


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3) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 6 months after last dose of the latest administered study drug. If the female partner of 
childbearing potential is not pregnant, use of any locally approved contraceptive method should 
also be considered.
Male patients must also refrain from sperm donation and cryopreservation of cells during 
treatment and until the end of contraception requirement. If needed, male patients should be 
advised to seek advice about sperm donation and cryopreservation prior to treatment.
4) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method. A female condom and a male condom should not be used 
together.
5) Procedures to be Followed in the Event of Pregnancy
Patients will be instructed to notify the investigator immediately if they become pregnant or 
suspect they are pregnant at any time from start of the study to 6 months post last study drug 
dose. Study drug must be discontinued immediately.
Patients whose partner has become pregnant or suspects she is pregnant from start of study to 
6 months post last study drug dose must also report the information to the investigator. 
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.4.2.3.


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Appendix 6.
Disease Response Criteria Based on European LeukemiaNet (ELN) 
and International Working Group (IWG) Criteria
Assessment of leukemia response in AML patients will be conducted using the ELN 2017 
recommendations for AML with modifications {Dohner 2017} (Table 30). Response 
classifications include: complete remission without minimal residual disease (CRMRD−), complete 
remission with positive or unknown minimal residual disease (CRMRD+/unk), CR with incomplete 
hematologic recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR), 
and stable disease (SD).
In addition, CR with partial hematologic recovery (CRh) will be assessed for AML, as defined as 
patients who achieve a CR per AML ELN 2017 recommendations {Dohner 2017}, but with only 
partial recovery of peripheral blood counts (platelets > 50  109/L and absolute neutrophil count 
(ANC) > 0.5  109/L)
Hematologic improvement will be assessed by 2006 IWG criteria {Cheson 2006} to compare 
with disease response assessed by 2017 ELN criteria {Dohner 2017}.
The date of the bone marrow assessment should be used as the date of response assessment. The 
complete blood count (CBC) results used for the response assessment will be derived from the 
best accompanying laboratory CBC result within the ± 2-week window of the bone marrow 
assessment used to support the efficacy response assessment. All components (eg, platelets, 
absolute neutrophils) should come from the same test. If disease progression or relapse is 
assessed based on CBC assessments or new extramedullary disease, other than bone marrow 
blast assessments, then the date of the corresponding CBC or new extramedullary disease 
assessment date will be used as the date of response assessment.


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Table 30.
Response Criteria in Acute Myeloid Leukemia (ELN 2017 
Recommendations with Modifications)
Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Complete 
Remission 
Without Minimal 
Residual Disease 
(CRMRD−) 
> 1.0  109/L
> 100  109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease. CR with 
MRD negative status as 
determined using multiparameter 
flow cytometry with a sensitivity 
of < 0.1%.
Complete 
Remission with 
MRD 
Positive/MRD 
Unknown 
(CRMRD+/unk)
> 1.0  109/L
> 100  109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD 
positive or unknown.
Complete 
Remission with 
Incomplete 
Hematologic 
Recovery (CRi)
Neutrophils > 1.0  109/L OR 
Platelets > 100  10
9/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; MRD 
positive or unknown.
(All CR criteria except residual 
neutropenia [< 1.0  109/L] or 
thrombocytopenia 
[< 100  109/L]).
Complete 
Remission with 
Partial 
Hematologic 
Recovery (CRh)a
> 0.5  109/L
> 50  109/L
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease.
Morphologic 
Leukemia-Free 
State (MLFS) 
< 5%
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease; no 
hematologic recovery required; 
marrow should not merely be 
“aplastic;” at least 200 cells 
should be enumerated, or 
cellularity should be at least 10%. 
Partial Remission 
(PR) 
> 1.0  109/L 
> 100  109/L 
Decrease of bone 
marrow blast 
percentage to 5% 
to 25%; and 
decrease of 
pretreatment bone 
marrow blast 
percentage by at 
least 50% 
Blasts < 5% with Auer rods may 
also be considered a PR. 


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Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Stable Disease 
(SD)
Absence of CRMRD−, CRMRD+/unk, CRi, CRh, PR, MLFS; and criteria for progressive disease 
not met 
Progressive 
Disease (PD) 
Evidence for an increase in bone marrow blast percentage and/or increase of absolute blast 
counts in the blood:
•
≥ 50% increase in marrow blasts over baseline (a minimum 15% point increase is 
required in cases with < 30% blasts at baseline; or persistent marrow blast percentage of 
> 70% over at least 3 months; without at least a 100% improvement in ANC to an 
absolute level (> 0.5  109/L [500/μL]), and/or platelet count to > 50  109/L 
(50,000/μL) non-transfused); or
•
≥ 50% increase in peripheral blasts (WBC x% blasts) to > 25  109/L (> 25,000/μL) 
(in the absence of differentiation syndrome); or
•
New extramedullary disease.
Hematologic 
relapse (after 
CRMRD−, 
CRMRD+/unk, CRi, 
CRh)
Bone marrow blasts ≥ 5%; or reappearance of blasts in the blood; or development of 
extramedullary disease
AML = acute myeloid leukemia; ANC = absolute neutrophil count; CR = complete remission; CRh = complete remission with 
partial hematologic recovery; CRi = complete remission with incomplete count recovery; CRMRD = complete remission without 
minimal residual disease; ELN = European LeukemiaNet; MLFS = morphologic leukemia-free state MRD = minimal residual 
disease; PD = progressive disease; PR = partial remission; SD = stable disease; WBC = white blood cell count
a
Not in the ELN 2017 guidelines. Modification for the purpose of this protocol. A response could be classified as both CRh 
and CRi if both criteria are met.
Source: {Dohner 2017}
Table 31.
Additional Response Definitions Used in This Study (2003 IWG 
Criteria)
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Cytogenetic CR 
(cCR)
> 1.0  109/L
> 100  109/L
< 5%
Cytogenetics 
normal and no 
evidence of 
extramedullary 
disease 
Treatment Failurea
Failure to achieve CR within 6 months of treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or up to 2 months of treatment with 7 + 3 chemotherapy 
cCR = cytogenetic complete remission; CR = complete remission; IWG = International Working Group
a.
Treatment failure defined for this protocol.
Source: {Cheson 2003}


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Table 32.
Response Criteria for Hematologic Improvement
Hematologic Improvement (HI) Categorya
Response Criteria 
Erythroid Response (HI-E)
(pretreatment < 110 g/L)
Pretransfusion increase in hemoglobin by 15 g/L
or
Compared to an 8-week pretreatment period, a 
reduction in transfusion requirements by 4 units in an 
8-week posttreatment period 
Platelet Response (HI-P)
(pretreatment < 100 × 109/L)
Absolute increase of ≥ 30  109/L for patient starting 
with a platelet count > 20  109/L pretreatment
or
Increase from < 20  109/L pretreatment to 
> 20  109/L post-treatment and by at least 100%
Neutrophil Response (HI-N)
(pretreatment < 1.0 × 109/L)
At least 100% increase and an absolute increase of 
> 0.5  109/L
Progression/relapse after Hematologic Improvementb
One or more of the following
≥ 50% decrement from maximum response in 
neutrophils or platelets
Reduction in hemoglobin by ≥ 15 g/L
Transfusion dependence
a 
Pretreatment counts should be an average of at least 2 measurements (not influenced by transfusions) performed ≥ 1 week 
apart.
b 
In the absence of another explanation. For example, including, but not restricted to, acute infection, gastrointestinal bleeding 
and hemolysis.
Source: {Cheson 2006}


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Appendix 7.
European Organisation for the Research and Treatment of Cancer 
Quality of Life Questionnaire–Core Questionnaire (EORTC 
QLQ-C30) 
ENGLISH 
E ORTC Q L Q-C30 (vmion 3) 
We are interested in some things about you and your health. Please answer all of the questions yourself by circling the 
number that best applies to you. There are no "right" or "wrong" answers. The infonnation that you provide will 
remain strictly confidential. 
Please fill in your initials: 
Your bi..rthdate (Day. Month, Year): 
Today's date (Day, Month, Year): 
3 I 
1. 
Do you have any trouble doing strenuous activities, 
like carrying a heavy shopping bag or a suitcase? 
2. 
Do you have any trouble taking a long walk? 
3. 
Do you have any trouble taking a short walk outside of the house. 
4. 
Do you need to stay in bed or a chair during the day? 
5. 
Do you need help with eating, dressing, wasb..i 
yourself or using tbe toilet? 
Dul'ing the past week: 
6. 
7. 
8. 
9. 
10. 
11. 
12. 
13. Have you Jacked appetite? 
14. Have you felt nauseated? 
15. Have you vomited? 
16. Have you been con tipated? 
Please go on to the next page 
4 
4 
3 
4 
2 
3 
4 
2 
3 
4 
Not at 
A 
Quite 
Very 
All 
Little 
a Bit 
Much 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 
2 
3 
4 


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ENGlJSH 
During the past week: 
Not at 
A 
Quite 
Very 
.All 
Little 
a Bit 
Much 
17. Have you had diarrhea? 
2 
3 
4 
18. Were you riced? 
2 
3 
4 
19. Did pain interfere with your daily activities? 
3 
4 
20. Have you had difficulty in concentrating on things, 
like reading a newspaper or watching television? 
4 
21. Did you feel tense? 
4 
22. Did you worry? 
4 
23. Did you feel irritable? 
4 
24. Did you feel depressed? 
3 
4 
25 . Have you had difficulty remembering things? 
3 
4 
26. Has your physic.al condition or medical treatmen 
interfered with your family life? 
2 
3 
4 
27. Has your physical condition or medical 
interfered with your social activities? 
2 
3 
4 
28. Has your physical conditi 
caused you financial di 
2 
3 
4 
Tie the numbH between 1 and 7 that 
29. 
4 
5 
6 
7 
Very 
Excellent 
30. 
ct rate your overall qualitv of life during the past week? 
2 
3 
4 
5 
6 
7 
Very poor 
Excellent 
I!:> Cop;-right 1995 EORTC Quality ofLife Group. All righls m er,ed. Version l .0 


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Appendix 8.
5-Level EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)
( ') EQ-5D-SL 
Health Questionnaire 
English version for the USA 
© 2009 EuroQol Research Foundation. EQ-5D™ is a trade mark of the EuroQol Research Foundation. USA /English) v1 .1 


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Under each heading, please check the ONE box that best describes your health TODAY. 
MOBILITY 
I have no problems walking 
I have slight problems walking 
I have moderate problems walking 
I have severe problems walking 
I am unable to walk 
SELF-CARE 
I have no problems washing or dressing myself 
I have slight problems washing or dressing myself 
I have moderate problems washing or dressing myself 
I have severe problems washing or dressing myself 
I am unable to wash or dress myself 
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities) 
I have no problems doing my usual activities 
I have slight problems doing my usual activities 
I have moderate problems doing my usual activities 
I have severe problems doing my usual activities 
I am unable to do my usual activities 
PAIN I DISCOMFORT 
I have no pain or discomfort 
I have slight pain or discomfort 
I have moderate pain or discomfort 
I have severe pain or discomfort 
I have extreme pain or discomfort 
ANXIETY/ DEPRESSION 
I am not anxious or depressed 
I am slightly anxious or depressed 
I am moderately anxious or depressed 
I am severely anxious or depressed 
I am extremely anxious or depressed 
2 
© 2009 EuroQol Research Foundation. EQ-50™ is a trade mark of the EuroQol Research Foundation. USA (English) v1 .1 


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• 
We would like to know how good or bad your health is TODAY. 
• 
This scale is numbered from O to 100. 
• 
100 means the best health you can imagine. 
0 means the worst health you can imagine. 
• 
Mark an X on the scale to indicate how your health is TODAY. 
• 
Now, please write the number you marked on the scale in the box 
below. 
YOURHEALTHTODAY= D 
3 
The best health 
you can imagine 
100 
95 
90 
85 
80 
75 
70 
65 
60 
55 
50 
45 
40 
35 
30 
25 
20 
15 
10 
5 
0 
The worst health 
you can imagine 
© 2009 EuroQol Research Foundation. EQ-5D™ is a trade mark of the EuroQol Research Foundation. USA (English) v1 .1 


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Appendix 9.
Patient Global Impression of Severity (PGIS) and Patient Global 
Impression of Change (PGIC)
HEALTH-RELATED QUALITY OF LIFE
PGIS: Please choose the response below that best describes your health-related quality of life 
(physical, social and psychological wellbeing) during the past week
•
Excellent
•
Good
•
Moderate
•
Poor
•
Very Poor
PGIC: All things considered, how did your health-related quality of life (physical, social and 
psychological wellbeing) change since you started taking the study medication?
•
Much improved
•
A little improved
•
No change
•
A little worsened
•
Much worsened 


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PHYSICAL FUNCTION
PGIS: Please choose the response below that best describes your physical function (the ability to 
carry out physical activities in your daily life) during the past week:
•
Excellent
•
Good
•
Moderate 
•
Poor
•
Very Poor
PGIC: All things considered, how did your physical function (the ability to carry out physical 
activities in your daily life) change since you started taking the study medication?
•
Much improved
•
A little improved
•
No change
•
A little worsened
•
Much worsened


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Appendix 10.
Eastern Cooperative Oncology Group Performance Status 
Eastern Cooperative Oncology Group Scale of Performance Status
Oken M, Creech R, Tormey D, et al. Toxicity and response criteria of the Eastern Cooperative 
Oncology Group. Am J Clin Oncol. 1982;5:649-655. Available online:
http://ecog-acrin.org/resources/ecog-performance-status. Accessed 18 February 2020.


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Appendix 11.
Cockcroft-Gault Method for Estimating Creatinine Clearance
Formulas for calculating the estimated creatinine clearance (eCcr) are provided in the table 
below. The formula appropriate to the units in which serum creatinine was measured and the 
subject’s gender should be used.
Serum 
Creatinine 
Units
Gender
Formula
(140-subject age [years]) x subject weight [kilograms] x 1
72 x subject serum creatinine [mg/dL]
(140-subject age [years]) x subject weight [kilograms] x 0.85
mg/dL
Males
Females
 eCcr =
[mL/min]
  eCcr =
[mL/min]
72 x subject serum creatinine [mg/dL]
(140-subject age [years]) x subject weight [kilograms] x 1.23
Subject serum creatinine [mg/dL]
(140-subject age [years]) x subject weight [kilograms] x 1.04
μM/dL
Males
Females
  eCcr =
[mL/min]
  eCcr =
[mL/min]
Subject serum creatinine [mg/dL]
Abbreviation: eCcr = estimated creatinine clearance
Source: {Cockcroft 1976}


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Appendix 12.
World Health Organization (WHO) Classification of AML
AML with recurrent genetic abnormalities (gene or chromosome changes)
•
AML with a translocation between chromosomes 8 and 21 [t(8;21)]
•
AML with a translocation or inversion in chromosome 16 [t(16;16) or inv(16)]
•
APL with the PML-RARA fusion gene
•
AML with a translocation between chromosomes 9 and 11 [t(9;11)]
•
AML with a translocation between chromosomes 6 and 9 [t(6;9)]
•
AML with a translocation or inversion in chromosome 3 [t(3;3) or inv(3)]
•
AML (megakaryoblastic) with a translocation between chromosomes 1 and 22 [t(1;22)]
•
AML with the BCR-ABL1 (BCR-ABL) fusion gene
•
AML with mutated NPM1 gene
•
AML with biallelic mutations of the CEBPA gene (that is, mutations in both copies of the 
gene)
•
AML with mutated RUNX1 gene
AML with myelodysplasia-related changes
AML related to previous chemotherapy or radiation
AML not otherwise specified (This includes cases of AML that do not fall into one of the above 
groups.)


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Appendix 13.
Amendment History
A high-level summary of this amendment is provided in tabular form in the subsection below, 
with changes listed in order of importance. Minor changes such as the correction of typographic 
errors, grammar, or formatting are not detailed. 
Separate summary of change documents for earlier amendments are available upon request.
A separate tracked change (red-lined) document comparing the Amendment 4 to this amendment 
will be made available upon the publication of this protocol.
Amendment 5 (02 November 2023)
Rationale for Key Changes Included in Amendment 5
Affected Sections
Added the information that the current study met futility and sites were informed 
of the outcome and sponsor’s decision in a communication in September 2023. 
Synopsis, Section 3.2, 
Section 7.3.2
Clarified that, in the event the study meets futility and is terminated, discontinued 
patients will not be followed for response or survival. Specifics about follow-up 
were clarified.
Section 3.2, Section 3.5, 
Section 3.7, Section 6.10, 
Section 7.3.2, Section 7.3.3, 
Section 8.2.1, Section 8.2.3
Clarification of collection of study samples and adverse events in the event that 
the study meets futility.
Section 3.9, Section 3.9.1, 
Section 3.9.2, Section 6.1.2, 
Section 6.4, Section 6.5, 
Section 6.6, Section 6.7, 
Section 6.8, Section 6.9, 
Section 8.5.4
Clarification that if the study meets futility and the sponsor decides to terminate 
the study, no further patients will be enrolled.
Section 4.1
Addition of “anemia, neutropenia, thrombocytopenia, and infections are known 
adverse drug reactions associated with both azacitidine and magrolimab”
Section 1.7
Updates were made to the Management of Infusion Related Reactions information 
section to incorporate the use of corticosteroids as premedication during the first 
few infusions of magrolimab, and to incorporate guidance for discontinuation of 
magrolimab in certain cases.
Table 16
Moved language about the objective and endpoint of time to first deterioration on 
the global health status/quality of life and on the physical functioning scales of the 
European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core Questionnaire (EORTC QLQ-C30) from secondary to 
 endpoints. 
Moved language on transfusion conversion rate from secondary to 
 
endpoints.
Changed endpoint and updated definition of TTD on the global health 
status/quality of life and on the physical functioning scales of the EORTC QLQ-
C30.
Synopsis, Section 2
CCI
CCI
-
-


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Rationale for Key Changes Included in Amendment 5
Affected Sections
Added language about the objective and endpoint comparing the efficacy of 
magrolimab + azacitidine versus physician’s choice of venetoclax + azacitidine or 
7 + 3 chemotherapy as measured by event-free survival (including CR, CRi, and 
CRh).
Synopsis, Section 2
Added language in the endpoint to clarify mean change from baseline on the 
EORTC QLQ-C30 domains, EQ visual analogue scale, and PGIS scale, as well as 
addition of descriptive summaries.
Section 2
Added language about the study meeting futility, study termination, and 
movement of patients to standard of care therapy, and provision of standard of 
care by the sponsor.
Synopsis, Section 3.2
Added information about post infusion monitory beginning after the infusion is 
complete.
Section 5.8
The update to Section 5.9 is to incorporate guidance for the use of corticosteroids 
as premedication for the first few infusions of magrolimab.
Section 5.9
Clarified SAE collection in the event that the study meets futility.
Section 7.3
Clarified that “significant drops (up to 3 g/dL or more) have also been observed in 
early doses.”
Section 7.8.1.1
Guidelines for dose delay and discontinuation are provided in case of severe 
neutropenia, serious infections, and IRR.
Section 5.10.1.1, Section 
7.8.1.2, Section 7.8.1.4, 
Section 7.8.1.5
Removal of time until meaningful definitive deterioration (TUDD) language for 
EORTC QLQ-C30 GHS/QoL scale and physical functioning scale in all patients. 
Table 1, Section 8.2.1.2, 
Table 19, Section 8.8
Clarification that if the study meets futility and is terminated, the planned interim 
analysis is no longer required.
Section 8.2.1
Clarification that if the study meets futility and is terminated, the planned primary 
analysis is no longer required.
Section 8.2.2
Updating the timing of adverse event and laboratory event collection.
Section 8.6.2, 8.6.3
Addition of a schedule of assessments table to clarify the treatment period for 
azacitidine or venetoclax+azacitidine in the event that the study meets futility and 
is terminated.
Table 26
Addition of a schedule of assessments table to clarify the treatment period for 
magrolimab in the event that the study meets futility and is terminated.
Table 27
Addition of a schedule of assessments table to clarify the post treatment period in 
the event that the study meets futility and is terminated.
Table 29
Addition of a schedule of assessments for repriming/reescalation (required after 
magrolimab delays of > 4 weeks) table to clarify the post treatment period in the 
event that the study meets futility and is terminated.
Table 30


Prot GS-US-546-5857 amd-5
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
02-Nov-2023
20:14:05
PPD-

SAP_001.pdf: 
STATISTICAL ANALYSIS PLAN
Study Title:
A Phase 3, Randomized, Open-Label Study Evaluating the 
Safety and Efficacy of Magrolimab in Combination with 
Azacitidine versus Physician’s Choice of Venetoclax in 
Combination with Azacitidine or Intensive Chemotherapy in 
Previously Untreated Patients with TP53 Mutant Acute 
Myeloid Leukemia
Name of Test Drug:
Magrolimab 
Study Number:
GS-US-546-5857
Protocol Version (Date):
Protocol Amendment 5 (02 November 2023)
Analysis Type:
Final Analysis
Analysis Plan Version:
Version 1.0
Analysis Plan Date:
07 May 2024
Analysis Plan Authors:
CONFIDENTIAL AND PROPRIETARY INFORMATION
PPD
(r) GILEAU 


Magrolimab
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Statistical Analysis Plan – Final Analysis
Version 1.0
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TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...............................................................................................................................1
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................7
1.1.
Study Objectives........................................................................................................................................7
1.2.
Study Design .............................................................................................................................................9
1.3.
Sample Size and Power ...........................................................................................................................13
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................14
2.1.
Interim Analyses......................................................................................................................................14
2.1.1.
Data Monitoring Committee (DMC) Analysis......................................................................14
2.1.2.
Interim Futility Analysis........................................................................................................14
2.1.3.
Interim Efficacy Analysis for Superiority .............................................................................15
2.2.
Primary Analysis .....................................................................................................................................16
2.3.
Final Analysis..........................................................................................................................................17
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................18
3.1.
Analysis Sets ...........................................................................................................................................18
3.1.1.
Intent-to-Treat (ITT) Analysis Set.........................................................................................18
3.1.2.
Safety Analysis Set................................................................................................................18
3.1.3.
Pharmacokinetic Analysis Set ...............................................................................................18
3.1.4.
Immunogenicity Analysis Set................................................................................................18
3.2.
Subject Grouping.....................................................................................................................................19
3.3.
Strata and Covariates...............................................................................................................................19
3.4.
Examination of Subject Subgroups .........................................................................................................19
3.5.
Adjustment for Multiplicity.....................................................................................................................20
3.6.
Missing Data and Outliers.......................................................................................................................20
3.6.1.
Missing Data..........................................................................................................................20
3.6.2.
Outliers ..................................................................................................................................20
3.7.
Data Handling Conventions and Transformations ..................................................................................20
3.8.
Analysis Visit Windows..........................................................................................................................21
3.8.1.
Definition of Study Day ........................................................................................................21
3.8.2.
Analysis Visit Windows........................................................................................................21
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................24
4.
SUBJECT DISPOSITION ...................................................................................................................................25
4.1.
Subject Enrollment and Disposition........................................................................................................25
4.2.
Extent of Study Drug Exposure and Relative Dose Intensity .................................................................26
4.2.1.
Duration of Exposure to Study Drug.....................................................................................26
4.2.2.
Relative Dose Intensity..........................................................................................................27
4.3.
Protocol Deviations .................................................................................................................................27
4.4.
Assessment of COVID-19 Impact...........................................................................................................28
4.4.1.
Study Drug Discontinuation Due to COVID-19 ...................................................................28
4.4.2.
Protocol Deviations Due to COVID-19 ................................................................................28
4.4.3.
Missed and Virtual Visits due to COVID-19 ........................................................................28
4.4.4.
Adverse Events Due to COVID-19 .......................................................................................28
5.
BASELINE CHARACTERISTICS .....................................................................................................................29


Magrolimab 
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Statistical Analysis Plan - Final Analysis 
Version 1.0 
5.1. 
Demographics and Baseline Characteristics ........................................................................................... 29 
5.2. 
Other Baseline Characteristics ................................................................................................................ 29 
5.3. 
Medical Histo1y ....................................................................................................................................... 29 
6. 
EFFICACY ANALYSES ..................................................................................................................................... 30 
6.1. 
Pri1nruy Efficacy Endpoint ...................................................................................................................... 30 
6.1.1. 
Definition of Prima1y Efficacy Endpoint .............................................................................. 30 
6.1.2. 
Statistical Hypothesis for the Primruy Efficacy Endpoint ..................................................... 30 
6.1.3. 
Analysis of Primruy Efficacy Endpoint ................................................................................. 30 
6.1.4. 
Follow-up Time ..................................................................................................................... 31 
6.1.5. 
Sensitivity Analyses of the Primruy Efficacy Endpoint.. ...................................................... 31 
6.2. 
Secondruy Efficacy Endpoints ................................................................................................................ 31 
6.2.1. 
Definition of Seconda1y Efficacy Endpoints ......................................................................... 31 
6.2.2. 
Analysis Methods for Seconda1y Efficacy Endpoints ........................................................... 33 
6.3. 
Estimands for Primru and Ke Seconda1 End oints ........................................................................... 34 
6.4. 
6.5. 
Other Efficacy Related Analyses ............................................................................................................. 39 
6.5.1. 
Time to Complete Remission ................................................................................................ 39 
6.5.2. 
Anti-AML Therapies ............................................................................................................. 39 
6.5.3. 
RBC and Platelet Transfusions .............................................................................................. 39 
6.6. 
Patient-Repo1t ed Outco1ne ...................................................................................................................... 39 
6.6.1. 
Definition of Patient-Repo1ted Outcome Data ...................................................................... 39 
6.6.2. 
Analysis of Patient-Repo1ted Outcome Data ....................................................................... .40 
7. 
SAFETY ANALYSES ........................................................................................................................................ .42 
7 .1. 
Adverse Events and Deaths .................................................................................................................... .42 
7 .1.1. 
Adverse Event Dictiona1y .................................................................................................... .42 
7.1.2. 
Adverse Event Severity ........................................................................................................ .42 
7.1.3. 
Relationship of Adverse Events to Study Dmg .................................................................... .42 
7 .1.4. 
Serious Adverse Events ........................................................................................................ .42 
7.1.5. 
Treatinent-Emergent Adverse Events ................................................................................... .42 
7.1.6. 
SUllllllaries of Adverse Events and Deaths ............................................................................ 43 
7 .1. 7. 
Additional Analysis of Adverse Events ................................................................................ 45 
7.2. 
Laborato1y Evaluations .......................................................................................................................... .46 
7.2.1. 
SUllllllaries of Numeric Laborat01y Results ......................................................................... .47 
7.2.2. 
Graded Laborato1y Values ................................................................................................... .47 
7.2.3. 
Liver-related Laborat01y Evaluations ................................................................................... .48 
7.3. 
Body Weight and Vital Signs ................................................................................................................. .49 
7.4. 
Prior and Concoinitant Medications ....................................................................................................... .49 
7.4.1. 
Prior Medications ................................................................................................................. .49 
7.4.2. 
Conco1nitant Medications ..................................................................................................... .49 
7.5. 
Electrocru·diogra1n Results ....................................................................................................................... 50 
7.6. 
Other Safety Measures ............................................................................................................................ 50 
7.7. 
Changes from Protocol-Specified Safety Analyses ................................................................................. 50 
8. 
PHARMA CO KINETIC (PK) AND IMMUNOGENECITY ANALYSES ......................................................... 51 
8.1. 
PK Sample Collection ............................................................................................................................. 51 
8.2. 
PK Analyses ............................................................................................................................................ 51 
8.3. 
Irmnunogenicity Analysis ........................................................................................................................ 52 
9. 
PHARMACODYNAMIC ANALYSES .............................................................................................................. 54 
10. REFERENCES ..................................................................................................................................................... 55 
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11.
SOFTWARE.........................................................................................................................................................56
12.
SAP REVISION...................................................................................................................................................57
13.
APPENDICES......................................................................................................................................................58
Appendix 1.
Schedule of Assessments.........................................................................................................58
Appendix 2.
Details for Futility Interim Analysis........................................................................................80
LIST OF IN-TEXT TABLES
Table 1-1.
Dosing and Schedule for Magrolimab and Azacitidine Experimental Arm............................10
Table 1-2.
Dosing and Schedule for Venetoclax and Azacitidine Control Arm.......................................11
Table 1-3.
Dosing and Schedule for 7 + 3 Chemotherapy Control Arm ..................................................11
Table 2-1.
Stopping Boundaries for Efficacy Analyses for Superiority...................................................16
Table 2-2.
Definition of Information Fraction..........................................................................................16
Table 3-1.
Analysis Visit Windows for Hematology Labs.......................................................................22
Table 3-2.
Analysis Visit Windows for Chemistry Labs..........................................................................23
Table 6-1.
Censoring Rules for EFS .........................................................................................................32
Table 6-2.
Estimands and Estimators of Main Analyses and Sensitivity Analyses for the 
Primary and Key Secondary Efficacy Endpoints ....................................................................35


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LIST OF ABBREVIATIONS
ADA
anti-drug antibody
AE
adverse event
ALT
alanine aminotransferase
ALP
alkaline phosphatase
AML
acute myeloid leukemia
AST
aspartate aminotransferase
ATC
Anatomical Therapeutic Chemical
BLQ
below the limit of quantitation
BMI
body mass index
BSA
body surface area
CI
confidence interval
COVID-19
coronavirus disease 2019
CR
complete remission
CRF
case report form
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete count recovery
CRMRD-
complete remission without minimal residual disease
CRMRD+/UNK
complete remission with positive or unknown minimal residual disease
CSR
clinical study report
CTCAE
Common Terminology Criteria for Adverse Events
CV
coefficient of variation
DCR
duration of complete remission
DMC
Data Monitoring Committee
DOR
duration of response
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
EFS
event-free survival
ELN
European Leukemia Net
EORTC QLQ-C30
European Organization for Research and Treatment of Cancer Quality of Life 
Questionnaire 
EQ-5D-5L
5-Level EuroQol 5 Dimensions
EQ VAS
EQ visual analogue scale
EOT
end of treatment
ET
early termination
GHS/QoL
Global Health Status/Quality of Life
Hb
hemoglobin
HiDAC
high-dose Cytarabine
HLT
high-level term
HLGT
high-level group term


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HRQoL
health-related quality of life
IA
Interim analysis
ICH
International Conference on Harmonization
ID
identification
IRR
infusion related reaction
IRT
interactive response technology
ITT
Intent-to-Treat
IWG
International Working Group
LLT
lower-level term
LOQ
limit of quantitation
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MLFS
morphologic leukemia-free state
MRD
minimal residual disease
MST
MedDRA Search Term
ORR
objective response rate
OS
overall survival
PR
partial remission
PRO
patient-reported outcome
PGIC
Patient Global Impression of Change
PGIS
Patient Global Impression of Severity
PK
pharmacokinetic
PT
preferred term
Q1, Q3
first quartile, third quartile
RBC
red blood cell
SAE
serious adverse event
SAP
statistical analysis plan
SCT
stem cell transplant
StD
standard deviation
SE
standard error
SI (units) 
international system of units
SMQ
Standardised MedDRA Queries
SOC
system organ class
TE
treatment-emergent
TEAE
treatment-emergent adverse event
TFLs
tables, figures, and listings
TTD
time to first deterioration
TTR
time to response
ULN
upper limit of normal
WHO
World Health Organization


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1.
INTRODUCTION
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in tables, figures, and listings (TFLs) of the final analyses for Study 
GS-US-546-5857. This SAP is based on the study protocol amendment 5 dated 02 November 
2023. Any changes made after the finalization of the SAP will be documented in the clinical 
study report (CSR). 
1.1.
Study Objectives
The primary objective of this study is as follows:
•
To compare the efficacy of magrolimab + azacitidine versus venetoclax + azacitidine in 
patients with previously untreated TP53 mutant acute myeloid leukemia (AML) who are 
appropriate for non-intensive therapy as measured by overall survival (OS).
The secondary objectives of this study are as follows:
•
To compare the efficacy of magrolimab + azacitidine versus physician’s choice of venetoclax 
+ azacitidine or 7 + 3 chemotherapy in all patients with previously untreated TP53 mutant 
AML as measured by OS.
•
To compare the efficacy of magrolimab + azacitidine versus physician’s choice of venetoclax 
+ azacitidine or 7 + 3 chemotherapy in all patients as measured by event-free survival (EFS).
•
To compare the efficacy of magrolimab + azacitidine versus physician’s choice of venetoclax 
+ azacitidine or 7 + 3 chemotherapy as measured by rate of complete remission (CR) within 
2 months of treatment for patients treated with 7 + 3 chemotherapy and within 6 months of 
treatment for other patients.
•
To compare the efficacy of magrolimab + azacitidine versus physician’s choice of venetoclax 
+ azacitidine or 7 + 3 chemotherapy as measured by rate of CR without minimal residual 
disease (CRMRD-) within 2 months of treatment for patients treated with 7 + 3 chemotherapy 
and within 6 months of treatment for other patients.
•
To compare the efficacy of magrolimab + azacitidine versus physician’s choice of venetoclax 
+ azacitidine or 7 + 3 chemotherapy in all patients as measured by the rate of CR + complete 
remission with partial hematologic recovery (CRh) within 2 months of treatment for patients 
treated with 7 + 3 chemotherapy and within 6 months of treatment for other patients.
•
To evaluate the duration of complete remission (DCR) in patients who achieved CR within 
6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 
2 months of 7 + 3 chemotherapy.
•
To evaluate the duration of CR + CRh in patients who achieved CR or CRh within 6 months 
of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months 
of 7 + 3 chemotherapy.


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To assess the safety and tolerability of magrolimab + azacitidine versus physician's choice of 
venetoclax + azacitidine or 7 + 3 chemotherapy. 
• 
To evaluate the phannacokinetics (PK) and immunogenicity of magrolimab. 
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Statistical Analysis Plan - Final Analysis 
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1.2. 
Study Design 
This is a Phase 3, randomized, open-label, multicenter study comparing 
magrolimab + azacitidine versus physician's choice of venetoclax + azacitidine or 7+3 
chemotherapy in patients with previously unti·eated TP53 mutant AML. Approximately 
Version 1.0 
346 patients will be randomized in 1: 1 ratio to receive either magrolimab + azacitidine 
(experimental aim) or physician's choice of venetoclax + azacitidine or 7 + 3 chemotherapy 
(conu-ol aim). Randomization will be sti·atified by 3 factors: 
• 
appropriateness for non-intensive therapy versus intensive therapy 
• 
age(< 75 yeai·s, 
75 yeai·s) 
• 
geographic region (United States [US], outside the US) 
Tnal Population 
CONFIDENTIAL 
Study Design 
Control. 
venetoclax + azac1t1d1ne 
Experimental 
magrol1mab + azac1t1d1ne 
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Stratification: 
1) Appropriateness for non-intensive therapy vs intensive therapy 
2) Age (<75 vs ;;,:75) 
3) Gecg-aphic region: (US vs. outside !he US) 
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The primary endpoint is OS in the stratum of patients appropriate for non-intensive therapy. The 
primary analysis of the OS will be conducted when 171 deaths have occurred in the stratum of 
patients appropriate for non-intensive therapy. An interim futility analysis and an interim 
superiority analysis will be conducted separately after approximately 69 and 128 deaths (40% 
and 75% of the expected 171 deaths, respectively) in the stratum of patients appropriate for 
non-intensive therapy have occurred. 
The study met futility based on an adhoc analysis with futility assessment conducted in August 
2023, and sites were informed of the outcome and sponsor’s decision to terminate the study 
earlier than planned in a communication in September 2023. If an investigator believes that 
continued treatment with magrolimab + azacitidine is in the best interest of their patient(s), 
Gilead will continue to provide study drug, with a reduced schedule of assessments, pending 
final study closure. In February 2024, a planned interim analysis of the Phase 3 ENHANCE-3 
study demonstrated futility in OS with an increased risk of death in the magrolimab-treatment 
arm. Based on the results, as well as data from the clinical study in higher-risk MDS 
(ENHANCE) and this study where the interim analyses also demonstrated futility with an 
increased risk of death in the magrolimab-treatment arm, FDA placed all magrolimab studies in 
MDS and AML, including related expanded access programs, on a full clinical hold. Gilead will 
not pursue further development of magrolimab in hematologic cancers. All AML patients who 
were remaining on magrolimab in this study have discontinued magrolimab and will leave study. 
The study treatments within each arm are as follows:
Table 1-1.
Dosing and Schedule for Magrolimab and Azacitidine Experimental 
Arm
Dose Schedule (Day per 28-day Cycle)
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Azacitidine 75 mg/m2 SC or 
IVa
Days 1–7
or
Days 1–5 and 8, 9b
Days 1–7
or
Days 1–5 and 8, 9b
Days 1–7
or
Days 1–5 and 8, 9b
Magrolimab Administration
Magrolimab 1 mg/kg IV 
(over 3 hours)
Days 1, 4
Magrolimab 15 mg/kg IV 
(over 3 hours)
Day 8
Magrolimab 30 mg/kg IV 
(over 2 hours)
Days 11 and 15, and then QW x 5 weekly 30 mg/kg dose 
Magrolimab 30 mg/kg IV 
(over 2 hours)
Q2W beginning 1 week after the 5 weekly 30 mg/kg dose
IV = intravenous; PO = orally; Q2W = every 2 weeks; QW = once a week; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive 
days.


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Table 1-2.
Dosing and Schedule for Venetoclax and Azacitidine Control Arm
Dose Schedule (Day per 28-day Cycle)
Control Arm
Drug/Dose/Route
Cycle 1
Cycle 2
Cycle 3+
Venetoclax 100 mg 
oral
Day 1
—
—
Venetoclax 200 mg 
oral
Day 2
—
—
Venetoclax 400 mg 
oral
Day 3 and daily 
thereafter
Daily
Daily
Venetoclax + 
Azacitidine
Azacitidine 
75 mg/m2 SC or IVa
Days 1–7
or
Days 1-5 and 8-9b
Days 1–7
or
Days 1-5 and 8-9b
Days 1–7
or
Days 1-5 and 8-9b
IV = intravenous; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.
b
Or any other alternative schedule, as long as the 7 doses of azacitidine of the cycle are administered within 9 consecutive 
days.
Table 1-3.
Dosing and Schedule for 7 + 3 Chemotherapy Control Arm
Control Arm 
(7+3)
Drug/Dose/Route
7 + 3 Induction
5 + 2 Induction, if needed 
(after C1D15 bone marrow 
assessment)
Daunorubicin 60 mg/m2 IVP
or 
Idarubicin 
12 mg/m2 IV
Days 1–3
Days 1-2
Induction
Cytarabine 
100 or 200 mg/m2 CI
Days 1–7
Days 1–5
Cytarabine (HiDAC) 1500 or 
3000 mg/m2 IVa
Every 12 hours on Days 1, 3, and 5
(up to 4 cycles)
Consolidation
Steroidal Eye Drops
As per institutional standard
C1D15 = Cycle 1 Day 15; CI = continuous infusion; IV = intravenous; IVP = intravenous peripheral
a
In some cases, patients ≥ 60 years of age can receive 1000 mg/m2 based on local practice.
For the experimental arm and the control arm venetoclax + azacitidine, cycle length is 28 days, 
and all patients will continue on study treatment until disease progression, relapse, loss of 
clinical benefit, or unacceptable toxicities occur. 
For patients treated with 7 + 3 chemotherapy (with or without 5 + 2 chemotherapy as indicated), 
induction followed by up to 4 cycles of consolidation with high-dose cytarabine (HiDAC) should 
be administered unless study treatment discontinuation criteria are met.
Patients will be discontinued from study treatment prior to starting stem cell transplant (SCT). 
No cross-over between arms is allowed.


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Treatment with azacitidine as SOC is recommended for a minimum of 6 cycles.  Therefore, in 
this study, for the patients in the magrolimab + azacitidine or venetoclax + azacitidine treatment 
arms, those without evidence of disease progression (including relapse), loss of clinical benefit, 
or unacceptable toxicity should continue study treatment. For those in the 7 + 3 chemotherapy 
treatment arm, treatment should continue until the end of the induction cycle(s).
Treatment with magrolimab or venetoclax as single agent is not permitted.  
Clinical response will be assessed using the guidelines in the study protocol Appendix 6 which 
are based primarily on European Leukemia Net (ELN) AML 2017 recommendation and the 2003 
International Working Group (IWG) AML response criteria with modifications. Response 
assessments will be performed in conjunction with bone marrow assessments, according to the 
schedule of assessments (Appendix 1). Accompanying laboratory results ± 2 weeks from the 
protocol-specified bone marrow efficacy assessment can be used to support an efficacy assessment, 
but peripheral blood smears for blasts should be done on the day of the bone marrow assessments. 
Response assessments for magrolimab + azacitidine and venetoclax + azacitidine are scheduled at 
Cycle 1 Day 28, Cycle 2 Day 28, Cycle 4 Day 28, Cycle 6 Day 28, and then at the end of every 
3 cycles thereafter during study treatment. For patients who receive control treatment with 7 + 3 
(5 + 2) chemotherapy, response assessments will be performed as summarized in the schedule of 
assessments in Appendix 1. These supporting laboratory results will be entered into the eCRF. If 
a patient achieves a CR, subsequent bone marrow assessments are still required to be performed 
as per the schedule of assessments in Appendix 1.
Response assessment will be obtained at the end of treatment (EOT) visit, unless a prior response 
assessment has been performed within the last 30 days or progressive disease has been 
documented, or if patient continues on long-term follow-up. Response assessments should 
continue during long-term follow-up approximately every 12 weeks until progressive disease is 
documented or start of a new anti-AML therapy (excluding SCT and maintenance). For patients 
who come off the study treatment to receive a SCT, follow-up for response assessment and 
collection of  bone marrow biopsy/aspirate results will continue every 12 weeks from the date of 
SCT, until documented disease progression or relapse or initiation of new anti-AML therapy 
(excluding maintenance therapy) occurs. Then patients will be observed for survival until death, 
withdrawal of consent, loss to follow-up, or the end of the study, whichever occurs first.
All patients will be followed for survival until death. For any patient who dies during this 
follow-up period, the immediate cause of death must be reported to the sponsor. 
The study met futility based on an adhoc analysis with futility assessment conducted in August 
2023, and sites were informed of the outcome and sponsor’s decision to early terminate the study 
in a communication in September 2023. All patients who discontinue study treatment for any 
reason will not be followed for response or survival. 


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1.3.
Sample Size and Power
Based on data from Study 5F9005, which enrolled 47 TP53 mutant AML patients treated with 
magrolimab + azacitidine with a median OS of 12.9 months {Sallman 2020}, and from studies 
for venetoclax in combination with hypomethylating agents that have shown a median OS 
ranging from 5.2 to 7.2 months in TP53 mutant AML patients {DiNardo 2019, Kim 2020}, it is 
assumed that administration of magrolimab + azacitidine to study patients will result in a median 
OS of approximately 9.77 months, improved from a median OS of 6.35 months in patients 
treated with venetoclax + azacitidine or 7 + 3 chemotherapy. This corresponds to an OS hazard 
ratio (HR) of 0.65.
It is assumed that the duration of OS is exponentially distributed in each of the 2 arms. With an 
HR equal to 1 under the null hypothesis of no difference between the 2 treatment arms, an HR 
of 0.65 under the alternative hypothesis of superiority of the magrolimab + azacitidine, a planned 
interim futility analysis and an interim superiority analysis when 40% and 75% of the OS events 
required for the primary analysis are observed respectively, a total of 171 OS events (deaths) in 
the stratum of patients appropriate for non-intensive therapy is required at the primary analysis to 
achieve a power of 79.7% based on a log-rank test with an overall 1-sided significance level 
of 0.025; approximately 234 deaths may be observed in all patients when 171 events occur in the 
stratum of patients appropriate for non-intensive therapy. That provides a power of 90.4% for the 
OS test in all patients based on the log-rank test.
The study will enroll a minimum of 228 patients appropriate for non-intensive therapy to ensure 
adequate events (171 deaths) for the primary endpoint analysis. The study enrollment may stop 
after 228 patients in the non-intensive therapy group or approximately 346 of all patients are 
enrolled, whichever occurs later. The study duration and the total number of patients to be 
enrolled will depend on the prevalence of patients appropriate for non-intensive therapy in the 
overall population. When the enrollment of the required number of all patients finishes later than 
that of patients in the non-intensive therapy group, assuming a planned accrual period of 
23 months, a study duration of 27 months, and an expectation that 10% of patients are likely to 
drop out by the end of study (annual dropout rate 4.8% assuming time to drop-out is 
exponentially distributed), approximately 173 patients in the experimental arm and 173 patients 
in the control arm (approximately 346 total) are to be enrolled. The study met futility based on an 
adhoc analysis with futility assessment conducted in August 2023, and sites were informed of the 
outcome and sponsor’s decision to terminate the study earlier than planned in a communication 
in September 2023. No further patients were enrolled. 


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Interim Analyses
2.1.1.
Data Monitoring Committee (DMC) Analysis
An external multidisciplinary data monitoring committee (DMC) will review the progress of the 
study and perform interim reviews of safety data in order to protect patient welfare and preserve 
study integrity. To ensure the best interests of the patients, the DMC will make recommendations 
to the sponsor if the nature, frequency, and severity of adverse effects associated with the study 
treatment warrant the early termination of the study, the continuation of the study, or the 
continuation of the study with modifications. 
In addition, the DMC will meet after approximately 69 and 128 OS events in the stratum of 
patients appropriate for non-intensive therapy have occurred to review the results from the 
planned interim analyses, as specified in Section 2.1.2 and 2.1.3. Based on the pre-specified 
futility and superiority rules, the DMC may make recommendations to Gilead on whether the 
study should be terminated early due to futility, should be stopped due to overwhelming efficacy, 
or should continue as planned. 
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct, and meeting schedule.
The DMC’s role and responsibilities and the scope of analysis to be provided to the DMC will be 
defined by a mutually agreed charter, which defines the DMC’s membership, conduct, and 
meeting schedule. 
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.
2.1.2.
Interim Futility Analysis
An interim analysis for futility is planned. This analysis will be performed after approximately 
69 deaths (40% of the expected 171 OS events) in the stratum of patients appropriate for non-
intensive therapy have occurred. The analysis will include a stratified log-rank test for OS in the 
stratum of patients appropriate for non-intensive therapy and will be reviewed by the DMC. A 
non-binding futility rule with a boundary HR = 1.1 will be implemented. The DMC may make a 
recommendation to terminate the study for futility if the observed HR for the OS in patients 
appropriate for non-intensive therapy is larger than 1.1. When the true OS HR in patients 
appropriate for non-intensive therapy is 0.74, the probability of observing HR > 1.1 at the interim 
analysis is less than 5%. Additional details are provided in Appendix 2. 


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2.1.3.
Interim Efficacy Analysis for Superiority
An interim efficacy analysis for OS superiority will be performed after approximately 128 deaths 
(75% of the expected 171 OS events) in the stratum of patients appropriate for non-intensive 
therapy have occurred, outstanding data queries have been resolved or adjudicated as 
unresolvable, and the data have been cleaned and finalized. The Lan-DeMets approach with 
O-Brien-Fleming type alpha spending function will be used to define the stopping boundaries for 
the primary endpoint OS in the stratum of patients appropriate for non-intensive therapy. The 
DMC will review unblinded interim analyses results and make recommendations per 
prespecified efficacy boundaries (refer to Table 2-1) to Gilead team as outlined in the DMC 
charter. 
To strongly control the overall Type I error across the testing of the primary and key secondary 
efficacy endpoints, a hierarchical testing strategy will be performed at the interim analysis for 
superiority and the primary analysis, respectively. The overall study-wide type I error is 
one-sided 0.025. An administrative one-sided type I error of 0.0001 will be spent for the interim 
futility analysis to protect the integrity of the study. As a result, the primary efficacy endpoint, 
OS in patients appropriate for non-intensive therapy, will be tested for superiority first at a 
one-sided significance level of 0.0249. If the OS interim results indicate superiority, analysis of 
key secondary efficacy endpoints with a one-sided significance level of 0.0249 will be performed 
in the following order: 
•
OS in all patients
•
EFS in all patients
•
Rate of CR within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy)
•
Rate of CRMRD- within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy)
•
Rate of CR + CRh within 6 months of treatment (2 months for patients receiving 7 + 3 
chemotherapy) 
A given hypothesis can only be tested and declared statistically significant if all previous 
hypotheses tested in the hierarchy are statistically significant. If the superiority test is failed at 
certain endpoint, all the hypothesis tests that follow thereafter will be considered descriptive with 
nominal significance (p-values) reported.
The Lan-DeMets approach with O’Brien-Fleming type alpha spending function will be used to 
account for multiplicity introduced by including the OS interim efficacy analysis for superiority. 
The stopping boundaries for the analyses of the primary endpoint OS in the stratum of patients 
appropriate for non-intensive therapy are provided in Table 2-1.


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Table 2-1.
Stopping Boundaries for Efficacy Analyses for Superiority
Stopping Boundary
Efficacy Analysis
Events (%a)
HR 
1-Sided P-Value 
IA
128 (75%)
0.661
0.010
Primary Analysis
171 (100%)
0.735
0.022
HR = hazard ratio; IA = interim analysis; OS = overall survival
a
Information fraction = number of events/total number of events × 100
For each key secondary endpoint, an O’Brien-Fleming type of boundary will be derived based on 
the information fraction defined at the interim efficacy analysis and the remaining type I error, 
respectively, per Table 2-2.
Table 2-2.
Definition of Information Fraction
Secondary Endpoint
Information Fraction at the Interim Analysis
OS in all patients 
75%, same with that of primary efficacy endpoint
EFS in all patients
75%, same with that of primary efficacy endpoint
Rate of CR within 6 months of treatment 
(2 months for patients receiving 7 + 3 
chemotherapy)
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
Rate of CRMRD- within 6 months of treatment 
(2 months for patients receiving 7 + 3 
chemotherapy) 
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
Rate of CR + CRh within 6 months of treatment 
(2 months for patients receiving 7 + 3 
chemotherapy)
Proportion of patients who have at least 7 months follow-up 
since randomization (3 months for patients receiving 7 + 3 
chemotherapy)
CR = complete remission; CRh = complete remission with partial hematologic recovery; CRMRD- = complete remission without 
minimal residual disease; EFS = event-free survival; OS = overall survival; 
If the OS interim analysis results do not meet the efficacy boundary for superiority, then the 
study will continue as planned. The study met futility based on an adhoc analysis with futility 
assessment conducted in August 2023, and sites were informed of the outcome and sponsor’s 
decision to early terminate the study in a communication in September 2023. The planned 
interim analysis for superiority is no longer required.
2.2.
Primary Analysis
If the null hypothesis on the primary endpoint of OS in the stratum of patients appropriate for 
non-intensive therapy is not rejected in the planned interim efficacy analysis, the primary 
efficacy analysis will be conducted when 171 deaths have occurred in the stratum of patients 
appropriate for non-intensive therapy. The analysis will be conducted after all outstanding data 
queries have been resolved or adjudicated as unresolvable, and the data have been cleaned and 
finalized for the analysis. The analysis of the primary endpoint OS in the stratum of patients 
appropriate for non-intensive therapy will be used to evaluate efficacy of magrolimab + 


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azacitidine compared with venetoclax + azacitidine in the patient population and will serve as the 
final analysis for this endpoint. The corresponding stopping boundary and the hierarchical 
hypothesis testing are specified in Section 2.1.3. If the null hypothesis of the primary endpoint 
OS is rejected in the interim efficacy analysis, the primary analysis timing will be determined by 
the maturity of the key secondary endpoints that have not been rejected in the interim analysis. 
The study met futility based on an adhoc analysis with futility assessment conducted in August 
2023, and sites were informed of the outcome and sponsor’s decision to terminate the study 
earlier than planned in a communication in September 2023. The planned primary analysis is no 
longer required.
2.3.
Final Analysis
The final analysis of the data will be performed after all patients have completed the study, 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized. The analysis of the primary endpoint of OS will be conducted at this 
time and will be descriptive in nature.
The study met futility based on an adhoc analysis with futility assessment conducted in August 
2023, and sites were informed of the outcome and sponsor’s decision to terminate the study 
earlier than planned in a communication in September 2023.  By the time the sponsor made the 
decision to end the study, 257 patients have been randomized. 


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3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of patients in each category will be presented; for continuous variables, 
the number of patients (n), mean, standard deviation (StD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented.
By-subject listings will be presented for all patients in the Intent-to-Treat (ITT) Analysis Set and 
sorted by treatment group, subject ID number, visit date, and time (if applicable). Data collected 
on log forms, such as AEs, will be presented in chronological order within the subject. Age, sex 
at birth, race, and ethnicity will be included in the listings, as space permits.
3.1.
Analysis Sets
Analysis sets define the patients to be included in an analysis. Analysis sets and their definitions 
are provided in this section. The analysis set will be identified and included as a subtitle of each 
table, figure, and listing.
For each analysis set, the number and percentage of patients eligible for inclusion will be 
summarized by treatment group.
3.1.1.
Intent-to-Treat (ITT) Analysis Set
The ITT Analysis Set includes all patients who were randomized in the study, with treatment 
assignment designated according to the treatment arm the subject is randomized to. This is the 
primary analysis set for efficacy analyses, unless otherwise specified. 
3.1.2.
Safety Analysis Set
The Safety Analysis Set includes all patients who took at least 1 dose of any study treatment, 
with treatment assignment designated according to the actual treatment received. This is the 
primary analysis set for safety analyses.
3.1.3.
Pharmacokinetic Analysis Set
The Pharmacokinetic (PK) Analysis Set will include all randomized patients who took at least 
one dose of magrolimab and have at least 1 measurable (non-BLQ numeric values) post-
treatment serum concentration of magrolimab. This is the primary analysis set for all PK 
analyses.
3.1.4.
Immunogenicity Analysis Set
The Immunogenicity Analysis Set will include all randomized patients who received at least 
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3.2.
Subject Grouping
For analyses based on the ITT Analysis Set, patients will be grouped according to the treatment 
to which they were randomized. For analyses based on the Safety Analysis Set, patients will be 
grouped according to the actual treatment received. The actual treatment received will differ 
from the randomized treatment only when their actual treatment differs from randomized 
treatment for the entire treatment duration.
For the PK Analysis Set and the Immunogenicity Analysis Set, patients will be grouped 
according to the actual treatment they received.
3.3.
Strata and Covariates
Patients will be randomized in a 1:1 ratio to treatment arms via an integrated response 
technology (IRT) with a stratified randomization schedule. Stratification will be based on the 
following variables:
•
appropriateness for non-intensive therapy versus intensive therapy 
•
age (< 75 years, ≥ 75 years)
•
geographic region (United States [US] sites, outside the US sites)
If there are discrepancies in stratification factor values between the IRT and the clinical database, 
the values recorded in the clinical database will be used for analyses. 
Efficacy endpoints will be evaluated using stratification factors as covariates or stratification 
variables for analyses when applicable, as specified in Section 6. If there is an imbalance in 
presumed prognostic baseline characteristics between treatment groups, efficacy evaluations may 
be performed that include these baseline values in efficacy analysis models as covariates; these 
evaluations will be considered as sensitivity analyses.
3.4.
Examination of Subject Subgroups
Subgrouping of patients based on randomization stratification factors may be explored for 
subgroup analyses. The primary and selected secondary efficacy endpoints  (defined in 
Section 6) may be examined using the following subgroups:
•
appropriateness for non-intensive therapy versus intensive therapy
•
age (< 75 years, ≥ 75 years) 
•
geographic region (US sites, outside the US sites) 
If there is an imbalance between treatment groups in presumed prognostic baseline 
characteristics that are not stratification factors, subgroupings based on these imbalanced 
baseline characteristics may also be explored for analysis of the primary endpoint and key 
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3.5.
Adjustment for Multiplicity
The adjustment for multiplicity (if applicable) is specified in Section 2.1.3. As the study is 
terminated early due to futility, no multiplicity adjustment is implemented.
3.6.
Missing Data and Outliers
3.6.1.
Missing Data
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document.
Imputation rules for missing date of birth are described in Section 3.7. The handling of missing 
or incomplete dates for date of death and the start date of new anti-AML therapy in 
Section 6.2.1, for AE onset in Section 7.1.5.2, and for prior and concomitant medications in 
Section 7.4. Imputation rules adopted in the efficacy analyses are specified in Section 6.
3.6.2.
Outliers
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analysis.
3.7.
Data Handling Conventions and Transformations
The following conventions will be used for the imputation of date of birth when it is partially 
missing or not collected:
•
If only month and year of birth is collected, then “15” will be imputed as the day of birth
•
If only year of birth is collected, then “01 July” will be imputed as the day and month of birth
•
If year of birth is missing, then date of birth will not be imputed
In general, age collected at the randomization (in years) will be used for analyses and presented 
in listings. If age at randomization is not available for a subject, then age derived based on date 
of birth and the randomization date will be used instead. For screen failures or unrandomized 
patients, the date the first informed consent was signed will be used for the age derivation. Age 
required for longitudinal and temporal calculations and analyses (eg, estimates of creatinine 
clearance, age at date of AE) will be based on age derived from date of birth and the date of the 
measurement or event, unless otherwise specified.
Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows:
•
A value that is 1 unit less than the lower LOQ will be used to calculate descriptive statistics if 
the datum is reported in the form of “ x” (where x is considered the lower LOQ). For 
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be used to calculate summary statistics. An exception to this rule is any value reported as < 1 
or < 0.1, etc. For values reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be 
used to calculate summary statistics.
•
A value that is 1 unit above the upper LOQ will be used to calculate descriptive statistics if 
the datum is reported in the form of “> x” (where x is considered the upper LOQ). Values 
with decimal points will follow the same logic as above.
•
The lower or upper LOQ will be used to calculate descriptive statistics if the datum is 
reported in the form of “≤ x” or “≥ x” (where x is considered the lower or upper LOQ).
If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data or nonparametric analysis methods may be used, 
as appropriate.
3.8.
Analysis Visit Windows
3.8.1.
Definition of Study Day
Study day will be calculated from the first dosing date of any study drug, which is the earliest 
dose date of magrolimab, venetoclax, azacitidine, or 7+3 chemotherapy and derived as follows:
•
For postdose study days: Assessment Date – First Dosing Date + 1
•
For days prior to the first dose: Assessment Date – First Dosing Date 
Therefore, study day 1 is the day of first dose of  any study drug administration. If the subject is 
randomized but not dosed, the randomization date will be study day 1. 
3.8.2.
Analysis Visit Windows
Subject visits might not occur on protocol-specified days. Therefore, for the purpose of analysis, 
observations will be assigned to analysis windows. The analysis windows for laboratory analytes 
are provided in Table 3-1 to Table 3-2.


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Table 3-1.
Analysis Visit Windows for Hematology Labs
Visit Window Study Daya
Analysis Visit
Nominal Study Visit or 
Study Day
Lower Limit
Upper Limit
Baseline
1b
Day 1 post-dose
Set 1 Day 1, post-dose
Cycle 1 Day 1, post-dose
Unscheduledd, post-dose
1c
1
Day 2 
Cycle 1 Day 2
Induction Cycle 1 Day 2
2
2
Day 3
Cycle 1 Day 3
3
3
Day 4 pre-dose
Set 1 Day 4, pre-dose
Cycle 1 Day 4
Induction Cycle 1 Day 4
Unschedulede, pre-dose
4
4
Day 4 post-dose
Set 1 Day 4, post-dose
Unscheduledf, post-dose
NA
NA
Week 1
8
5
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx (every other 
week from Week 10)
xx*7 + 1
xx*7-6
xx*7+7
a
The 1st magrolimab/placebo infusion date is considered as Day 1 in study day calculation if patients are administered 
magrolimab/placebo. 
b
On or prior to first magrolimab date/time if the patient is infused with magrolimab, otherwise use first dose date/time of any 
study drug.
c
Post first magrolimab date/time if the patient is infused with magrolimab, otherwise use first dose date/time of any study 
drug.
d
Hemoglobin collected at unscheduled post-dose visit on the same day of or one day after Set 1 Day 1 visit is mapped to 
Day 1 post-dose. 
e
Hemoglobin collected at unscheduled pre-dose visit on the same day of Set 1 Day 4 visit is mapped to Day 4 pre-dose.
f
Hemoglobin collected at unscheduled post-dose visit on the same day of or one day after Set 1 Day 4 visit is mapped to 
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Table 3-2.
Analysis Visit Windows for Chemistry Labs
Visit Window Study Day
Analysis Visit
Nominal Study Visit or Study Day
Lower Limit
Upper Limit
Baseline
1a
Day 1 Post-Dose 6-8 Hour
Cycle 1 Day 1, 6-8 Hour Post-Dose
Unscheduledb, 6-8 Hour post-dose
NA
NA
Day 2 Pre-Dose
Cycle 1 Day 2
Induction Cycle 1 Day 2
Unscheduled
2
2
Day 2 Post-Dose 6-8 Hour
Cycle 1 Day 2, 6-8 Hour Post-Dose
Unscheduledc, 6-8 Hour post-dose
NA
NA
Day 3 Pre-Dose
Cycle 1 Day 3
Unscheduled
3
3
Day 3 Post-Dose 6-8 Hour
Cycle 1 Day 3, 6-8 Hour Post-Dose
Unscheduledd, 6-8 Hour post-dose
NA
NA
Day 4 Pre-Dose
Cycle 1 Day 4
Induction Cycle 1 Day 4
Unscheduled
4
4
Week 1
8
5
11
Week 2
15
12
18
Week 3
22
19
25
Week 4
29
26
32
Week 5
36
33
39
Week 6
43
40
46
Week 7
50
47
53
Week 8
57
54
63
Week 10
71
64
77
Week xx (every other week 
from Week 10)
xx*7 + 1
xx*7-6
xx*7+7
a
On or prior to first dose date/time of any study drug.
b
Laboratory records collected at unscheduled 6-8 hour post-dose visit on the same day of or one day after Cycle 1 Day 1 visit 
is mapped to Day 1 post-dose 6-8 hour. 
c
Laboratory records collected at unscheduled 6-8 hour post-dose visit on the same day of or one day after Cycle 1 Day 2 visit 
is mapped to Day 2 post-dose 6-8 hour. 
d
Laboratory records collected at unscheduled 6-8 hour post-dose visit on the same day of or one day after Cycle 1 Day 3 visit 
is mapped to Day 3 post-dose 6-8 hour. 
e
Laboratory records collected at unscheduled 24 hour post-dose visit on the same day of or one day after Cycle 1 Day 3 visit 
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For any data relating to unscheduled visits, the following rules will be implemented:
•
An unscheduled visit prior to the first dosing of any study drug will be included in the 
calculation of the baseline value, if applicable.
•
Unscheduled visits after the first dosing of any study drug will be included in determining the 
maximum postbaseline toxicity grade and anti-magrolimab antibody status.
•
Response assessments and patient-reported outcome (PRO) assessments performed at 
unscheduled visits after the date of randomization will be included in the analyses of the 
efficacy endpoints and the PRO related endpoints, respectively.
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window 
If multiple valid, nonmissing measurements exist in an analysis window, records will be chosen 
based on the following rules if a single value is needed:
•
For baseline, the last nonmissing value on or prior to the first dosing date of study drug will 
be selected, unless specified differently. If there are multiple records with the same time or 
no time recorded on the same day, the baseline value will be the arithmetic average of the 
measurements for continuous data, or the measurement with the lowest severity for 
categorical data.
•
For postbaseline values:
The record closest to the nominal day for that visit will be selected.
If there are 2 records that are equidistant from the nominal day, the later record will be 
selected.
If there is more than 1 record on the selected day, the arithmetic average will be taken for 
continuous data and the worse severity will be taken for categorical data, unless 
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4.
SUBJECT DISPOSITION
4.1.
Subject Enrollment and Disposition
A summary of subject enrollment will be provided by treatment group for each country, 
investigator and overall. The summary will present the number and percentage of patients 
enrolled. For each column, the denominator for the percentage calculation will be the total 
number of patients analyzed for that column.
A similar enrollment table will be provided by randomization stratum. The denominator for the 
percentage of patients in the stratum will be the total number of enrolled patients. If there are 
discrepancies in the value used for stratification assignment between the IRT and the clinical 
database, the value collected in the clinical database will be used for the summary. A listing of 
patients with discrepancies in the value used for stratification assignment between the IRT and 
the clinical database at the time of data finalization will be provided.
The randomization schedule used for the study will be provided as an appendix to the CSR.
A summary of subject disposition will be provided by treatment group. This summary will 
present the number of patients screened and the number of patients who screen failed, and the 
number of patients in each of the categories listed below by treatment group:
•
ITT Analysis Set
•
Safety Analysis Set 
•
Continuing study treatment (magrolimab+ azacitidine [by therapy appropriateness], 
venetoclax + azacitidine, intensive chemotherapy)
•
Discontinued study treatment (magrolimab+ azacitidine [by therapy appropriateness], 
venetoclax + azacitidine, intensive chemotherapy) with reasons for discontinuation
•
Continuing study (if applicable)
•
Discontinued study with reasons for discontinuation
For the status of study drug and study completion and reasons for discontinuation, the number 
and percentage of patients in each category will be provided. The denominator for the percentage 
calculation will be the total number of patients in the ITT Analysis Set corresponding to that 
column. 
The following by-subject listing will be provided by subject identification (ID) number in 
ascending order to support the above summary tables:
•
Reasons for study drug discontinuation
•
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4.2.
Extent of Study Drug Exposure and Relative Dose Intensity
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and relative dose intensity. Each variable will be calculated for magrolimab, 
venetoclax, azacitidine, and the 7+3 (or 5+2) chemotherapy separately. Analyses will be 
performed separately in the strata of patients appropriate for non-intensive therapy and 
appropriate for intensive therapy.  No formal statistical testing between treatment group is 
planned. 
4.2.1.
Duration of Exposure to Study Drug
4.2.1.1.
Study Drug: Magrolimab, Venetoclax, and Azacitidine
Total duration of exposure to each study drug (magrolimab, venetoclax, and azacitidine) will be 
defined for a subject as last dosing date minus first dosing date plus 1 day, regardless of any 
temporary interruptions in study drug administration, and will be expressed in weeks using up to 
1 decimal place (eg, 4.5 weeks). 
The total duration of exposure to each study drug will be summarized using descriptive statistics 
for continuous variables, as well as using the number (i.e., cumulative counts) and percentage of 
patients exposed for at least the following time periods: 1 day, 1 week, 4 weeks, 6 weeks, 
8 weeks, 12 weeks, 16 weeks, 20 weeks, and 24 weeks etc. 
Number of patients exposed to magrolimab for at least the following time periods: 1 day, 1 week, 
4 weeks, 6 weeks, 8 weeks, 12 weeks, etc, in the original schedule of magrolimab administration 
before any repriming (Set 1) and number of patients entering maintenance period in Set 1 will be 
summarized. 
The number of cycles patients are exposed to venetoclax or azacitidine will be summarized using 
descriptive statistics, and the number and percentage of patients who received at least 1, 2 …, 6, 
9, 12, 15 cycles will be presented.
The number and percentage of patients who have infusion interruption, entire dose delayed or 
missed  and the reasons will be summarized. 
A by-subject listing of each study drug administration will be provided by treatment group, 
subject ID number (in ascending order) and visit (in chronological order).
4.2.1.2.
Study drug: 7+3 Chemotherapy Regimen
The exposure to each of the chemotherapy agent will be summarized by the number of doses 
received using descriptive statistics. The number and percentage of patients who receive each 
distinct number of doses (5 doses, 7 doses, 14 doses, etc.) will be provided. The dose of 
cytarabine (HiDAC) used during consolidation cycles will be summarized.
The number and percentage of patients who received at least 1, 2 induction cycles and 1, 2, etc 
consolidation cycles will be presented.


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4.2.2.
Relative Dose Intensity
Relative dose intensity is the percentage of the total amount of study drug administered relative 
to the total amount of study drug expected to be administered during a subject’s actual 
on-treatment period based on the study drug regimen. 
For magrolimab:
The relative dose intensity is the percentage of the total amount of study drug administered 
relative to the total amount of study drug expected to be administered. 
Relative dose intensity (%) 
= 
Cumulative Dosages of Magrolimab Administered (in mg/kg)
Magrolimab Dosage Expected to be Administered on Treatment(in mg/kg)  x 100
Cumulative dosage (mg/kg) administered for each subject is defined as the sum of dosages 
(mg/kg) of all infusions the subject received . 
Magrolimab dosage expected to be administered on treatment (mg/kg) for each subject is defined 
as the total amount of magrolimab the subject was expected to receive during the subject’s 
treatment period.
For venetoclax:
Relative dose intensity (%) = 
Total Amount of Venetoclax Administered(mg)
Venetoclax Expected to be Administered on Treatment (mg)  x 100
For azacitidine:
Relative dose intensity (%) = 
Total Amount of Azacitidine Administered (mg/m2)
Azacitidine Expected to be Administered on Treatment(mg/m2)  x 100
For each study drug, descriptive statistics for the relative dose intensity with the number and 
percentage of patients belonging to relative dose intensity categories (eg, < 75%, ≥ 75 to < 90%, 
≥ 90%) will be provided by treatment group for the Safety Analysis Set.
For venetoclax, concomitant medications in Posaconazole/Other Strong CYP3A 
inhibitor/Moderate CYP3A inhibitor/P-gp inhibitor will be considered to reduce the amount of 
venetoclax expected to be administered.
4.3.
Protocol Deviations 
Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with at least 1 important protocol deviations 
by deviation category (e.g., eligibility criteria, informed consent) will be summarized by 
treatment group for the ITT Analysis Set. A by-subject listing will be provided for those patients 
with important protocol deviation. 
(--------) 
(-------) 
(-------) 


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Patients who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
presented regardless of whether they were exempted by the sponsor or not. A by-subject listing 
will be provided for those patients who did not meet at least 1 eligibility (inclusion or exclusion) 
criterion. The listing will present the eligibility criterion (or criteria if more than 1 deviation) that 
patients did not meet and related comments, if collected.
4.4.
Assessment of COVID-19 Impact
This study was ongoing during the novel coronavirus disease (COVID-19) pandemic which has 
an impact on the study conduct. Some patients were unable to attend onsite visits due to shelter 
in place guidelines, site closures, or other reasons. This section describes how special situations 
due to COVID-19 will be handled in the analysis.
4.4.1.
Study Drug Discontinuation Due to COVID-19
A summary of reasons for discontinuing study drug due to COVID-19 will be provided by 
treatment group and overall, similar to the summary described in the subject enrollment and 
disposition section (see Section 4.1). 
A by-subject listing of reasons for study drug discontinuation due to COVID-19 will be provided 
if applicable.
4.4.2.
Protocol Deviations Due to COVID-19
A by-subject listing will be provided for patients with protocol deviations related to COVID-19 
if applicable. 
4.4.3.
Missed and Virtual Visits due to COVID-19
A by-subject listing of patients with missed or virtual visits due to COVID-19 will be provided if 
applicable.
4.4.4.
Adverse Events Due to COVID-19
A by-subject listing of AEs of COVID-19 will be provided if applicable.


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5.
BASELINE CHARACTERISTICS  
5.1.
Demographics and Baseline Characteristics
Subject demographic variables (including age, age group [< 75 years, ≥ 75 years], sex, race/ 
ethnicity) and baseline characteristics (including body weight [in kg], height [in cm], body mass 
index [BMI; in kg/m2], Body Surface Area [BSA; in m2]) will be summarized by treatment group 
and overall using descriptive statistics for continuous variables and using number and percentage 
of patients for categorical variables. The summary of demographic data will be provided for the 
ITT Analysis Set.
A by-subject demographic listing, including the informed consent date, will be provided by 
treatment group and subject ID number.
5.2.
Other Baseline Characteristics
Other baseline characteristics include but are not limited to biallelic 17p deletion/TP53 
mutational status, Eastern Cooperative Oncology Group (ECOG) performance status, and World 
Health Organization (WHO) AML classification, and investigators’ reasons for appropriateness 
of non-intensive therapy. These baseline characteristics will be summarized by treatment group 
and overall using descriptive statistics for continuous variables and using number and percentage 
of patients for categorical variables. The summary of these baseline characteristics will be 
provided for the ITT Analysis Set. No formal statistical testing is planned.
A by-subject listing of other baseline characteristics will be provided.
5.3.
Medical History
Medical history will be collected at screening for disease-specific and general conditions 
(ie, conditions not specific to the disease being studied).
General medical history data will not be coded, but will be listed only. A by-subject listing of 
general medical history will be provided by subject ID number in ascending order.


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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoint
6.1.1.
Definition of Primary Efficacy Endpoint
The primary efficacy endpoint of this study is overall survival (OS) in the stratum of patients 
appropriate for non-intensive therapy. OS is defined as the interval from the date of 
randomization to the date of death from any cause. Patients whose deaths are not observed 
during the study will be censored at the last date that they were known to be alive. 
The last known alive date for a subject will be determined by selecting the last available date 
across all datasets. 
Every attempt will be made to ensure that complete death dates are recorded. In those rare 
instances where complete death dates are not recorded, the following algorithm will be used:
•
If day is missing but the month and year are available, then the imputed date will be the first 
day of the month or the last known alive date + 1, whichever is later.
•
If day and month are missing but year is available, then the imputed date will be 01Jan of 
that year or the last known alive date + 1, whichever is later.
6.1.2.
Statistical Hypothesis for the Primary Efficacy Endpoint 
The primary efficacy hypothesis to be tested is that there is no difference between magrolimab + 
azacitidine (experimental arm) and venetoclax + azacitidine (control arm) in OS for patients 
appropriate for non-intensive therapy. Using SE(t) and SC(t) to denote the OS distribution 
functions of the experimental arm and control arm, respectively, the statistical hypotheses to be 
tested in this study will be:
          𝐻0: SE(t) = SC(t) at all time points t
𝐻1: SE(t) > SC(t) (experimental arm is superior to control arm in terms of OS for 
some t >0)
6.1.3.
Analysis of Primary Efficacy Endpoint
The primary analysis of OS will compare the OS distributions of two treatment groups in 
patients appropriate for non-intensive therapy using the stratified log-rank test, stratified by the 
stratification factors at randomization for the ITT Analysis Set. Medians, Q1, Q3 of the OS 
distributions, and the proportion of patients who are alive at 3,  6, 9,  and 12 months from 
randomization will be estimated along with corresponding 95% CIs using the Kaplan-Meier 
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In addition, the HR between the 2 treatment groups and its 95% CI will be estimated using the 
Cox proportional hazards regression model with Efron’s method of tie handling, stratified by the 
stratification factors at randomization. 
6.1.4.
Follow-up Time
The follow-up time for OS is defined as the interval from date of randomization to the death date 
for patients who died during the study, or from the date of randomization to the earlier of the loss 
to follow-up or the last known alive date for patients who are alive while on study or loss to 
follow-up. The follow-up time will be summarized by treatment groups using descriptive 
statistics including median and range (minimum and maximum). 
6.1.5.
Sensitivity Analyses of the Primary Efficacy Endpoint
To assess the robustness of the primary OS results, the following sensitivity analyses will be 
performed:
Sensitivity Analyses (same definition of the endpoint, different analysis approach): 
•
OS will be analyzed using the unstratified log-rank test.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Overall Survival in All Patients: The OS is measured from the date of randomization to the 
date of death from any cause. Those whose deaths are not observed during the study will be 
censored at their last known alive date.
Event-Free Survival in All Patients: The EFS is defined as time from the date of 
randomization to the earliest date of the documented relapse from CR, treatment failure (defined 
as failure to achieve CR within 6 months of treatment with magrolimab + azacitidine or 
venetoclax + azacitidine, or up to 2 months of treatment with 7 + 3 chemotherapy), or death from 
any cause. Response assessments or death post SCT or new anti-AML therapies will be included 
in the analysis.  The date of randomization will be assigned as the event date for patients with 
treatment failure. 
Patients who are not observed to have one of the above specified events during the study will be 
censored at the date of their last response assessment with clear documentation of no relapse 
while on study. Patients will be censored at the date of randomization if no response assessment 
is performed after randomization and the patients did not die. 
Table 6-1 summarizes the details of the EFS derivation algorithm.


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Table 6-1.
Censoring Rules for EFS
Scenario
Event/Censored
Event/Censored Date
Had relapse or death
Event
(Relapse/death)
Relapse date or death 
date whichever occurs 
first
Subject achieved CR* within 
6 months from the 
randomization date (or 
2 months of treatment with 
7 + 3 chemotherapy)
No relapse or death
Censored
Last assessment date
Had progression, death or new 
anti-AML therapies within the 
window
Event
(Treatment 
Failure)
Randomization Date
No progression, death or new 
anti-AML therapies within the 
window, and have been on 
study beyond the window
Event
(Treatment 
Failure)
Randomization Date
Within 6 months (or 2 months 
of treatment with 7 + 3 
chemotherapy), subject had at 
least one post-baseline 
assessment, but didn’t achieve 
CR within that time
No progression, death or new 
anti-AML therapies within the 
window, and haven’t been on 
study beyond the window
Censored
Randomization Date
Had death or new anti-AML 
therapies within the window
Event
(Treatment 
Failure)
Randomization Date
Within 6 months (or 2 months 
of treatment with 7 + 3 
chemotherapy), subject had no 
post-baseline response 
assessment
No death or new anti-AML 
therapies within the window
Censored
Randomization Date
*CRs achieved before SCT or new anti-AML therapies.
When the date of initiation of a new anti-AML therapy other than the study treatment or the date 
of SCT is incomplete or missing, the following algorithm will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first day of the month or the day of last dose + 1 if the month and year of new anti-AML 
therapy/SCT and the month and year of last dose are the same.
•
If day and month are missing but year is available, then the imputed day and month will be 
01Jan, or the date of last dose + 1 if the year of new anti-AML therapy/SCT and the year of 
last dose are the same.
Rate of CR within 6 Months of Treatment in All Patients (2 months for patients receiving 
7 + 3 chemotherapy): The CR rate is the proportion of patients who achieve a CR, including 
CRMRD- and CR with positive or unknown minimal residual disease (CRMRD+/unk) within 
6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 
2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on the ELN 
2017 for AML with modifications (Protocol Appendix 6), while on study prior to initiation of 
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Rate of CRMRD- within 6 Months of Treatment in All Patients (2 months for patients 
receiving 7 + 3 chemotherapy): The CRMRD- rate is the proportion of patients who achieve a 
CRMRD- within 6 months of treatment with magrolimab + azacitidine or venetoclax + azacitidine, 
or within 2 months of treatment with 7 + 3 chemotherapy, as defined by investigators based on 
the ELN 2017 for AML with modifications (Protocol Appendix 6), while on study prior to 
initiation of any new anti-AML therapy or SCT.
Rate of CR+CRh within 6 Months of Treatment in All Patients (2 months for patients 
receiving 7 + 3 chemotherapy): The CR + CRh rate is the proportion of patients who achieve a 
CR (including CRMRD- and CRMRD+/unk) or CRh as defined by CR with partial platelet and 
absolute neutrophil count recovery (Protocol Appendix 6) within 6 months of treatment with 
magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 
chemotherapy while on study prior to initiation of any new anti-AML therapy or SCT. 
Duration of CR: The DCR is measured from the time the assessment criteria are first met for 
CR (including CRMRD- and CRMRD+/unk) within 6 months of treatment with magrolimab + 
azacitidine or venetoclax + azacitidine, or within 2 months of treatment with 7 + 3 chemotherapy 
until the first date of AML relapse or death (including assessments post SCT). Those who are not 
observed to have relapsed disease or death while on study will be censored at the date of their 
last response assessment with no evidence of relapse during the study. If patients start taking new 
anti-AML therapies (excluding post-SCT maintenance therapy) before relapse, DCR will be 
censored at the last response assessment before the initiation of the new anti-AML therapies.
Duration of CR+CRh: The duration of CR+CRh is measured from the time the assessment 
criteria are first met for CR (including CRMRD- and CRMRD+/unk) or CRh within 6 months of 
treatment with magrolimab + azacitidine or venetoclax + azacitidine, or within 2 months of 
treatment with 7 + 3 chemotherapy until the first date of AML relapse or death (including 
assessments post SCT). Those who are not observed to have relapsed disease or death while on 
study will be censored at the date of their last response assessment with no evidence of relapse. If 
patients start taking new anti-AML therapies (excluding post-SCT maintenance therapy) before 
relapse, duration of CR+CRh will be censored at the last response assessment before the 
initiation of the new anti-AML therapies.
6.2.2.
Analysis Methods for Secondary Efficacy Endpoints
Key secondary efficacy endpoints will be tested according to the order specified in Section 2.1.3, 
after the superiority for the primary efficacy endpoint is established. 
6.2.2.1.
Overall Survival in All Patients
Analyses of OS in all patients will be conducted in a similar manner as that of the primary 
efficacy endpoint OS in the stratum of patients appropriate for non-intensive therapy, as 
specified in Section 6.1.3. Sensitivity analyses of OS in all patients will be conducted similarly 
as specified in Section 6.1.5.


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6.2.2.2.
Event-Free Survival in All Patients
The distribution of EFS in all patients will be estimated for each treatment arm using 
Kaplan-Meier methodology and compared between treatment arms using the stratified log-rank 
test,  stratified by the stratification factors at randomization for the ITT Analysis Set. Medians, 
Q1, Q3 of the EFS distributions, and the proportion of patients who are event-free at 3, 6, 9, and 
12 months from randomization will be estimated along with corresponding 95% CIs using the 
Kaplan-Meier method. Kaplan-Meier curves will be provided by treatment group. The hazard 
ratio between treatment arms along with 95% CI will be estimated using the Cox proportional 
hazards regression model stratified by the stratification factors at randomization. 
6.2.2.3.
CR rate, CRMRD- rate, CR+CRh rate and Durations of Remissions
The point estimate of the CR rate within 6 months (2 months for patients receiving 7+3 
chemotherapy) and the corresponding 2-sided exact 95% CI based on the Clopper-Pearson 
method will be provided for each arm in the ITT Analysis Set. Patients, who are randomized but 
have no on-study response assessment or receive any new anti-AML therapy or SCT prior to 
achieving CR, will be considered as non-responders. 
CR rates between the 2 treatment arms will be compared using the Cochran-Mantel-Haenszel 
test, stratified by the randomization stratification factors. Odds ratio comparing the 2 arms 
adjusted for the stratification factors will be presented along with 95% CI. 
The CRMRD- rate and CR+CRh rate will be evaluated in a similar manner as the CR rate.
For the time-to-event endpoints of DCR and duration of CR+CRh, analyses will be conducted 
based on the subsets on which the outcome measures are defined. Specifically, DCR will be 
based on patients who achieve CR, and duration of CR+CRh will be based on patients who 
achieve CR or CRh. Kaplan-Meier method will be used to estimate median duration with its 
95% CI.
6.3.
Estimands for Primary and Key Secondary Endpoints
Following the ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials, 
a summary of the aforementioned primary and key secondary endpoints are presented in the 
estimand framework. Table 6-2 summarizes the attributes of estimands and estimators defined 
for main analyses and sensitivity analyses. The sensitivity analyses will not be included in the 
hierarchical testing planned in Section 2.1.3. 
The target population of the estimand for the primary objective is AML TP53 mutant patients 
appropriate for non-intensive therapy. For all the estimands of secondary objectives listed in the 
tables except for transfusion independence conversion, the target population attribute is all 
AML TP53 mutant patients defined by the study inclusion and exclusion criteria. For transfusion 
independence conversion rates, the target population attribute is the AML TP53 mutant patients 
defined by the inclusion and exclusion criteria with transfusion dependence at baseline.


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Table 6-2.
Estimands and Estimators of Main Analyses and Sensitivity Analyses for the Primary and Key 
Secondary Efficacy Endpoints
Treatments
Variable (Endpoint)
Intercurrent Events & Strategies
Population Level 
Summary 
Estimators
magrolimab + azacitidine 
(experimental arm) vs. 
venetoclax + azacitidine 
(control arm), and with 
SCT/new anti-AML 
therapy as needed
OS (in patients 
appropriate for non-
intensive therapy)
•
Discontinuation of treatment: 
treatment policy
•
SCT, New anti-AML therapy: 
treatment policy 
Kaplan-Meier estimates, 
hazard ratio
Main Estimator: Test the difference 
by a stratified logrank test;
Estimate hazard ratio from a 
stratified Cox regression model.
Sensitivity Estimator: Test the 
difference by a unstratified logrank 
test; Estimate hazard ratio from a 
unstratified Cox regression model.
magrolimab + azacitidine 
(experimental arm) vs. 
physician’s choices of 
venetoclax + azacitidine or 
intensive therapy (control 
arm), and with SCT/new 
anti-AML therapy as 
needed
OS (in all patients)
•
Discontinuation of treatment:  
treatment policy
•
SCT, New anti-AML therapy: 
treatment policy 
Kaplan-Meier estimates, 
hazard ratio
Main Estimator: Test the difference 
by a stratified logrank test;
Estimate hazard ratio from a 
stratified Cox regression model.
Sensitivity Estimator: Test the 
difference by a unstratified logrank 
test; Estimate hazard ratio from a 
unstratified Cox regression model.
magrolimab + azacitidine 
vs. physician’s choices of 
venetoclax + azacitidine or 
intensive therapy, and with 
SCT as needed
EFS
•
Discontinuation of treatment:  
treatment policy
•
Death, Treatment failure: 
composite
•
SCT: treatment policy 
•
New anti-AML therapy: 
treatment policy   
Kaplan-Meier estimates, 
hazard ratio
Main Estimator: Test the difference 
by a stratified logrank test;
Estimate hazard ratio from a 
stratified Cox regression model.


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Treatments
Variable (Endpoint)
Intercurrent Events & Strategies
Population Level 
Summary 
Estimators
magrolimab + azacitidine 
vs. physician’s choices of 
venetoclax + azacitidine or 
intensive therapy
CR / 
CRMRD- /
CR+CRh 
•
Discontinuation of treatment:  
treatment policy
•
SCT, New anti-AML therapy: 
while-on-treatment
Odds ratio;  CR rate/ 
CRMRD- rate/ rate of 
CR+CRh while on 
study, prior to initiation 
of SCT or new anti-
AML therapy
Main Estimator: Test the treatment 
effect in terms of odds ratio by a 
stratified Cochran-Mantel-Haenszel 
test;
Estimate rate and CIs based on the 
Clopper-Pearson method.


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6.5. 
6.5.1. 
Other Efficacy Related Analyses 
Time to Complete Remission 
Version 1.0 
Time to complete remission response (TCR) is defined as the interval from randomization to the 
first documentation of CR (CRMRD. or CRMRD+1un1c) prior to initiation of new anti-AML therapy or 
SCT. TCR may be summarized using descriptive statistics by treatment group for patients 
achieving at least one of the CR as defined in the ITT Analysis Set. 
6.5.2. 
Anti-AML Therapies 
All post treatment anti-AML therapies will be provided in a by-subject listing sorted by subject 
ID number, treatment group, and administration date in chronological order. 
6.5.3. 
RBC and Platelet Transfusions 
A by-subject listing for RBC and platelet transfusions required throughout the study will be 
provided by subject ID and ti·eatment group in chronological order. Date of ti·ansfusion, 
ti·ansfusion type, and the number of units ti·ansfused will be presented. 
6.6. 
6.6.1. 
Patient-Reported Outcome 
Definition of Patient-Reported Outcome Data 
Four patient-repo1ted outcome (PRO) instruments will be administered in this study: the 
EORTC- QLQ-C30, the EQ-5D-5L, the PGIS, and the PGIC. 
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The EORTC QLQ-C30 is a 30-item PRO instrument that assesses cancer-related symptoms and 
impacts. The instrument is separated into 5 functional scales (physical functioning, role 
functioning, emotional functioning, cognitive functioning, and social functioning), 1 global 
health status scale, 3 multi-item symptom scales (fatigue, nausea and vomiting, and pain) and 
6 single-item symptom scales ( dyspnea, insomnia, loss of appetite, constipation, dianhea, and 
financial difficulties). Subjects rate items on a four-point scale, with 1 as "not at all" and 4 as 
"ve1y much", except that the GHS/QoL which utilizes a 7-point scale. Items 1 to 5 has an 
unspecified recall period, and the remaining items have a recall period "in the past week". 
The EQ-5D-5L is an instrument for use as a measure of health outcome and consists of 
2 sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The 
questionnaire is provided in the protocol Appendix 8. 
The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight 
problems, moderate problems, severe problems, and extreme problems. The patient is asked to 
indicate his/her health state by ticking the box next to the most appropriate statement in each of 
the 5 dimensions. This decision results in a I-digit number that expresses the level selected for 
that dimension. The digits for the 5 dimensions can be combined into a 5-digit number that 
describes the patient's health state. 
The EQ VAS records the patient's self-rated health on a ve1tical VAS, where the endpoints are 
labeled "the best health you can imagine" and "the worst health you can imagine." The EQ VAS 
can be used as a quantitative measure of health outcome that reflects the patient's own judgment. 
The PGIS and PGIC assessments are both single-item assessments used to demonstr·ate 
sensitivity and meaningful change thresholds and bolster the validity of selected PRO 
assessments for health-related quality of life and the physical function. The questionnaires are 
provided in the protocol Appendix 9. 
6.6.2. 
Analysis of Patient-Reported Outcome Data 
Because the study was terminated early due to fotility, analyses of the PRO endpoints are not 
planned for the final CSR. Previously planned PRO analyses are documented in the following 
paragraphs. 
Raw scores of domain scales/items from the EORTC QLQ-C30 will be tr·ansfonned to 0-100 
before analysis according to the cunent EORTC QLQ-C30 Scoring Manual (3£d Edition). TTD 
on the GHS/QoL scale and TTD on the physical functioning scale will be respectively analyzed 
using the Kaplan-Meier method on the ITT Analysis Set. The log-rank test sh'atified by 
randomization str·atification factors will be conducted for the TTD comparison between 
tr·eatinent anns, and the HR estimated using a Cox propo1tional hazard regression model 
str·atified by randomization str·atification factors will be provided. 
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The EQ-5D-5L questionnaire data will be scored, processed, and standardized according to the 
user manual. The EQ-5D-5L status will be converted into a single preference-weighted health 
utility index score by applying US weights,  unless otherwise specified. 
Descriptive statistics will be calculated for all the EORTC QLQ-C30 symptom and functioning 
scales and single items the EQ-5D-5L utility score, the EQ-5D VAS score, and PGIS/PGIC 
response score at scheduled assessments. The mean and change from baseline to each subsequent 
assessment will be summarized by treatment group. Changes from baseline in HRQoL as 
measured by mean change from baseline scores in scales/items of the EORTC QLQ-C30, EQ 
VAS score, and EQ-5D-5L utility score will be analyzed. 
Proportion of patients who report each response category on the PGIC and PGIS at scheduled 
time-point will be summarized by treatment group. The mean and change from baseline on the 
PGIS to each subsequent assessment may be summarized.


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7.
SAFETY ANALYSES
7.1.
Adverse Events and Deaths
7.1.1.
Adverse Event Dictionary
Clinical and laboratory adverse events (AEs) will be coded using MedDRA v26.1. System organ 
class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and 
lower-level term (LLT) will be provided in the AE dataset.
7.1.2.
Adverse Event Severity
Adverse events are graded by the investigator as Grade 1, 2, 3, 4, or 5 according to Common 
Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The severity grade of events for 
which the investigator did not record severity will be categorized as “missing” for tabular 
summaries and data listings. The missing category will be listed last in summary presentation.
7.1.3.
Relationship of Adverse Events to Study Drug
Related AEs are those for which the investigator selected “Related” for a study drug on the AE 
CRF to the question of “Related to Study Treatment.” Relatedness will always default to the 
investigator’s choice, not that of the medical monitor. Events for which the investigator did not 
record relationship to study drug will be considered related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing. 
7.1.4.
Serious Adverse Events
Serious adverse events (SAEs) will be identified and reported as SAEs if the AEs met the 
definitions of SAEs that were specified in the study protocol. SAEs captured and stored in the 
clinical database will be reconciled with the SAE database from the Gilead Global Patient Safety 
before data finalization.
7.1.5.
Treatment-Emergent Adverse Events 
7.1.5.1.
Definition of Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) are defined as any AE that begins on or after the 
date of first dose of study treatment up to the date of last dose of study treatment plus 70 days or 
the day before initiation of new anti-AML therapy including SCT, whichever occurs first. If the 
AE onset date is on or before the last dose date, the AE is considered as TEAE regardless of the 
start of new anti-AML therapy.


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7.1.5.2.
Incomplete Dates
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met:
•
The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and
•
The AE onset date is the same as or before the month and year (or year) of the date 
corresponding to the cutoff date of TEAE period, which is defined as the 70 days after the 
study drug last dose date or the day before initiation of any new anti-AML therapy including 
SCT,  whichever occurs first.  
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent.
In case when the AE onset date is incomplete and needs to be imputed, the following algorithm 
will be followed:
•
If the day is missing but the month and year are available, then the imputed day will be the 
first dosing date if they have the same month and year, or the first day of the month 
otherwise.
•
If the day and month are missing but year is available, then the imputed day and month will 
be the first dosing date if they have the same year, or 01Jan otherwise.
7.1.6.
Summaries of Adverse Events and Deaths
Treatment-emergent AEs will be summarized based on the Safety Analysis Set.
7.1.6.1.
Summaries of AE incidence in Combined Severity Grade Subsets 
A brief, high-level summary of the number and percentage of patients who experienced at least 
1 TEAE in the categories described below will be provided by treatment group. All deaths 
observed in the study will also be included in this summary.
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by SOC, PT, and treatment group. 


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For the AE categories described below, summaries will be provided by SOC, PT, maximum 
severity (as applicable), and treatment group:
•
TEAEs 
•
TEAEs with Grade 3 or higher
•
Treatment-related TEAEs for each study drug 
•
TE SAEs
•
Treatment-related TE SAEs for each study drug
•
TEAEs leading to discontinuation of each study drug 
•
TEAEs leading to death 
•
TEAEs leading to dose interruption of study drug (magrolimab, azacitidine, venetoclax) 
•
TEAEs leading to dose reduction of study drug (magrolimab, azacitidine, venetoclax) 
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and then by PT in descending order of 
total frequency within each SOC. For summaries by severity, the most severe severity will be 
used for those AEs that occurred more than once in a given subject during the study.
In addition to the above summary tables, all TEAEs, TEAEs of Grade 3 or higher, TE SAEs and 
Treatment-related TEAEs and Treatment-related TE SAEs will be summarized by PT only in 
descending order of total frequency.
In addition, data listings will be provided for the following:
•
All AEs, indicating whether the event is treatment emergent
•
All SAEs
•
All Deaths
•
All AEs leading to death 
•
All AEs with severity of Grade 3 or higher
•
All AEs leading to discontinuation of magrolimab
•
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A summary (number and percentage of patients) of deaths will be provided by treatment group. 
Summary will include the following categories:
•
All deaths
•
Deaths within 30 days of the first dosing of study drug
•
Deaths within 60 days of the first dosing of study drug
•
Deaths within 30 days of the last dosing of study drug
•
Deaths beyond 30 days of the last dosing of study drug
•
Deaths within 70 days of the last dosing of study drug
•
Deaths beyond 70 days of the last dosing of study drug
7.1.7.
Additional Analysis of Adverse Events
7.1.7.1.
Treatment-Emergent Adverse Events (TEAEs) of Special Interest
Number and percentage of patients with the following AEs of special interest will be 
summarized by PT: 
•
Anaemia (MedDRA Search Term (MST) - Anemia Extravascular Transient Hemolysis)
•
Infusion-Related Reaction (IRR) (Standardised MedDRA Queries (SMQ)-Hypersensitivity 
Narrow Terms) + within one day of latest infusion of any study drug
•
Severe Neutropenia (PT - Neutrophil Count Decreased, Neutropenia and Febrile Neutropenia 
with Grade 3 or Higher)
•
Serious Infections (SOC - Infections and infestations with Serious AE)
•
Transfusion reactions due to magrolimab interference with RBC typing (Gilead’s MST)
•
Thromboembolic Events (SMQ- Embolic and Thrombotic Events Broad Terms)
•
Pneumonitis (SMQ- Interstitial Lung Disease Broad Terms)
Number and percentage of patients with the following AEs of special interest will also be 
summarized by AE onset time within 2 weeks, >2weeks - 2 months, >2 months to 6 months, 
>6 months to 12 months, and >12 months of first dosing of any study drug:
•
Anaemia
•
IRR
•
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•
Serious Infections
•
Transfusion reactions due to magrolimab interference with RBC typing 
•
Thromboembolic Events
•
Pneumonitis
A high-level summary of the number and percentage of patients who experienced at least 1 AE 
of special interest as defined above will be provided by treatment group.
7.1.7.2.
Other Important Safety Topics
Number and percentage of patients with the following AEs of important safety topics will be 
summarized by PT: 
•
Immune-Mediated Events (SMQ-Immune-mediate and autoimmune disorder Narrow Terms)
•
Hemorrhages (SMQ - Haemorrhages Broad Terms)
Number and percentage of patients with the AEs of important safety topics will also be 
summarized by first AE onset time within 2 weeks, >2 weeks to 2 months, >2 months to 
6 months, >6 months to 12 months, and >12 months of first dosing of any study drug.
A high-level summary of the number and percentage of patients who experienced at least 1 AE 
of important safety topics as defined above will be provided by treatment group.
7.1.7.3.
Regrouped AE Terms 
For the regrouped AE terms described below, summaries will be provided by treatment group:
•
Regrouped Anaemia and Haemoglobin Decreased
•
Regrouped Neutropenia and Neutrophil Count Decreased
•
Regrouped Thrombocytopenia and Platelet Count Decreased
7.2.
Laboratory Evaluations
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to the last dose of study drug plus 70 days 
or the day before initiation of new anti-AML therapy including SCT, whichever occurs first. If 
the laboratory data collection date is on or before the last dose date, the laboratory data is 
included regardless of the start of new anti-AML therapy. The analysis will be based on values 
reported in conventional units. When values are below the LOQ, they will be listed as such, and 
the closest imputed value will be used for the purpose of calculating summary statistics as 
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A by-subject listing for laboratory test results will be provided by treatment group, subject ID 
and visit in chronological order for hematology and serum chemistry separately. Values falling 
outside of the relevant reference range and/or having a severity grade of 1 or higher on the 
CTCAE severity grade will be flagged in the data listings, as appropriate.
No formal statistical testing is planned.
7.2.1.
Summaries of Numeric Laboratory Results
Descriptive statistics will be provided by treatment group for hematology and serum chemistry 
laboratory tests specified in the study protocol as follows:
•
Baseline values 
•
Postbaseline maximum and minimum values 
•
Change and percentage change from baseline to postbaseline maximum and minimum value
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of any study drug. Change from baseline to a postbaseline visit will be 
defined as the postbaseline value minus the baseline value. The mean, median, Q1, Q3, 
minimum, and maximum values will be displayed to the reported number of digits; StD values 
will be displayed to the reported number of digits plus 1.
Median (Q1, Q3) of the observed values will be plotted using a line plot by treatment group and 
visit for the laboratory tests including but not limited to hemoglobin, platelet, and absolute 
neutrophil counts.
In the case of multiple values associated with a visit, data will be selected for analysis as 
described in Section 3.8.3.
7.2.2.
Graded Laboratory Values
The CTCAE Version 5.0 will be used to assign toxicity grades (0 to 4) to laboratory results for 
analysis. Grade 0 includes all values that do not meet the criteria for an abnormality of at least 
Grade 1. For laboratory tests with criteria for both increased and decreased levels, analyses for 
each direction (ie, increased, decreased) will be presented separately. 
7.2.2.1.
Treatment-Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point ,up to and including the date of last 
dose of study treatment plus 70 days or the day before initiation of any new anti-AML therapy 
including SCT, whichever occurs first. If the relevant baseline laboratory value is missing, any 
abnormality of at least Grade 1 observed within the time frame specified above will be 
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7.2.2.2.
Summaries of Laboratory Abnormalities
Laboratory data that are categorical will be summarized using the number and percentage of 
patients in the study with the given response at baseline and each scheduled postbaseline time 
point.
The following summaries (number and percentage of patients) for treatment-emergent laboratory 
abnormalities will be provided by laboratory test and treatment group; patients will be 
categorized according to the most severe postbaseline abnormality grade for a given laboratory 
test:
•
Graded TE laboratory abnormalities
•
TE Grade 3 or 4 laboratory abnormalities
For all summaries of laboratory abnormalities, the denominator is the number of patients with 
nonmissing postbaseline values up to 70 days after the last dosing date or the day before 
initiation of new anti-AML therapy including SCT, whichever occurs first.
A by-subject listing of treatment-emergent Grade 3 or 4 laboratory abnormalities will be 
provided by subject ID number and visit in chronological order. This listing will include all test 
results that were collected throughout the study for the lab test of interest, with all applicable 
severity grades displayed.
7.2.3.
Liver-related Laboratory Evaluations
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of patients who were reported to have the following laboratory 
test values for postbaseline measurements:
•
Aspartate aminotransferase (AST): > 3 times of the upper limit of reference range (ULN)
•
Alanine aminotransferase (ALT): > 3 x ULN
•
AST or ALT: > 3 x ULN
•
Total bilirubin: > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN
•
AST or ALT > 3 x ULN and total bilirubin > 2 x ULN and alkaline phosphatase (ALP) < 2 x 
ULN
The summary will include data from all postbaseline visits up to 70 days after the last dose of 
study drug, or the day before initiation of any new anti-AML therapy including SCT, whichever 
occurs first. For individual laboratory tests, patients will be counted once based on the most 


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severe postbaseline values. For the composite endpoints of AST or ALT, and total bilirubin, 
patients will be counted once when the criteria are met at the same postbaseline visit date. The 
denominator is the number of patients in the Safety Analysis Set who have nonmissing 
postbaseline values of all relevant tests at the same postbaseline visit date. 
A listing of patients who met at least 1 of the above criteria will be provided.
7.3.
Body Weight and Vital Signs
No summary or listing of body weight, BMI or vital signs will be provided to align with the 
planned scope of the study synoptic CSR. 
7.4.
Prior and Concomitant Medications
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.
7.4.1.
Prior Medications
Prior medications are defined as any medications taken before a subject takes the first study 
drug. For the purposes of analysis, any medication with a start date prior to the first dosing date 
of study drug will be categorized as the prior medication regardless of when the stop date is. If a 
partial start date is entered, the medication will be considered prior unless the month and year (if 
day is missing) or year (if day and month are missing) of the start date are after the first dosing 
date. Medications with a completely missing start date will be included in the prior medication 
summary, unless otherwise specified. 
7.4.2.
Concomitant Medications
Concomitant medications are defined as medications taken while a subject took study drug. For 
the purposes of analysis, any medications with a start date prior to or on the first dosing date of 
study drug and continued to be taken after the first dosing date, or started after the first dosing 
date but prior to or on 70 days after the last dosing date of study drug will be considered 
concomitant medications. Medications started and stopped on the same day as the first dosing 
date or 70 days after the last dosing date of study drug will also be considered concomitant. 
Medications with a stop date prior to the date of first dosing date of study drug or a start date 
after the last dosing date of study drug plus 70 days will be excluded from the concomitant 
medication summary. If a partial stop date is entered, any medication with the month and year (if 
day is missing) or year (if day and month are missing) prior to the date of first study drug 
administration will be excluded from the concomitant medication summary. If a partial start date 
is entered, any medication with the month and year (if day is missing) or year (if day and month 
are missing) after the study drug stop date plus 70 days will be excluded from the concomitant 
medication summary. Medications with completely missing start and stop dates will be included 
in the concomitant medication summary, unless otherwise specified. 


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All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order. 
Analysis will be based on the ITT Analysis Set. No formal statistical testing is planned.
7.5.
Electrocardiogram Results
A standard 12-lead electrocardiogram (ECG) will be performed using local standard procedures 
at screening for all patients and at subsequent visits for patients undergoing treatment with 7+3 
intensive therapy, as specified in Appendix 2 of the protocol. Electrocardiogram (ECG) analysis 
results are intended to identify meaningful changes in the QT interval. Because the study was 
terminated early due to futility, no ECG analysis is planned for the final CSR.  
7.6.
Other Safety Measures
A by-subject listing of pregnancy test report will be provided by subject ID number in ascending 
order.
7.7.
Changes from Protocol-Specified Safety Analyses
There are no deviations from the protocol-specified safety analyses.


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8.
PHARMACOKINETIC (PK) AND IMMUNOGENECITY 
ANALYSES
8.1.
PK Sample Collection
Blood samples for evaluating magrolimab serum concentrations will be collected as described in 
Protocol Appendix 2.
8.2.
PK Analyses 
The magrolimab PK concentration will be summarized for the PK Analysis Set. Individual 
subject’s concentration data for magrolimab will be listed based on the sampling time point. 
Magrolimab PK data will be summarized using descriptive statistics. Summary statistics (n, 
mean, SD, coefficient of variation [%CV], median, min, max, Q1, and Q3) will be presented for 
magrolimab serum concentration data at time point. 
The sample size (number of patients) at each time point will be based on the number of patients 
with nonmissing concentration data at that time point. Missing concentration values will be 
reported as is in data listings. The number of patients with concentration BLQ will be presented 
for each time point. 
Sparse PK concentration values that are BLQ will be presented as “BLQ” in the concentration 
data listing. Values that are BLQ will be treated as 0 at predose and postdose time points for 
summary purposes.
At predose, if all concentration values are BLQ, then the mean, and order statistics (minimum, 
Q1, median, Q3, and maximum) will be displayed as 0 and the rest of the summary statistics (ie, 
SD and CV) will be missing. If any values are non-BLQ, then the number of samples, order 
statistics, and all summary statistics will be displayed.
At any given postdose time point, if more than one-third of the patients have a concentration 
value of BLQ , then only the number of samples and order statistics  will be displayed; 
otherwise, order statistics and summary statistics will be displayed.
The following conventions will be used for the presentation of order statistics for postdose time 
points: 
•
If at least 1 subject has a concentration value of BLQ for the time point, the minimum value 
will be displayed as “BLQ.”
•
If more than 25% of the patients have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
•
If more than 50% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 


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•
If more than 75% of the patients have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
•
If all patients have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.”
Due to the sparse nature of PK collection, PK parameters will not be calculated.
8.3.
Immunogenicity Analysis
The rate and magnitude of anti-drug antibody (ADA) prevalence, incidence, persistence, and 
transience will be summarized for the Immunogenicity Analysis Set. Neutralizing antibody 
occurrence rate will also be summarized. 
ADA Prevalence: the proportion of patients who had at least one positive ADA sample (baseline 
or post-baseline) based on the Immunogenicity Analysis Set.
Treatment-Induced ADA Rate: the proportion of patients who had negative baseline ADA 
sample and at least one positive post-treatment ADA sample based on patients who had both 
non-missing baseline and at least one post-treatment ADA result reported (i.e. ADA Incidence 
Analysis Set).
Treatment-Boosted ADA Rate: the proportion of patients who had positive baseline ADA 
sample and at least one positive post-treatment ADA sample and the (max titer of the 
post-treatment ADA) / (titer of baseline ADA) >= 4 based on the ADA Incidence Analysis Set.
ADA Incidence (treatment-emergent ADA): the proportion of patients who had treatment-
induced or treatment-boosted ADA based on patients who had at least one non-missing baseline 
ADA sample and at least one post-treatment ADA result reported in Immunogenicity Analysis 
Set.
Persistent ADA is defined as:
a) Treatment-Induced ADA detected at two or more sampling time points during the 
treatment (including follow-up period if any), where the first and last ADA-positive 
sample (irrespective of any negative samples in between) are separated by a period of 
16 weeks or longer. 
or
b) Treatment-Induced ADA detected in the last sampling time point of the treatment study 
period.
ADA Persistence Rate: the proportion of patients who had persistent ADA based on the ADA 
Incidence Analysis Set.


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Transient ADA is defined as: 
Version 1.0 
Treatment-Induced ADA that does not meet the definition of persistent ADA. The propo1iion of 
patients who had transient ADA is based on the patients evaluable for ADA incidence. 
Neutralizing antibody (NAb) Incidence: the propo1iion of patients who had at least one 
positive neutralizing antibody result repo1ied based on the treatment-emergent ADA 
(treatment-induced or treatment-boosted ADA) among the patients evaluable for ADA incidence. 
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10.
REFERENCES
DiNardo CD, Pratz K, Pullarkat V, Jonas BA, Arellano M, Becker PS, et al. Venetoclax 
combined with decitabine or azacitidine in treatment-naive, elderly patients with 
acute myeloid leukemia. Blood 2019;133 (1):7-17.
Kim K, Maiti A, Kadia TM, Ravandi F, Daver N, Pemmaraju N, et al. 693 Outcomes of TP53-
Mutant Acute Myeloid Leukemia with Venetoclax and Decitabine. ASH 2020 
(62nd ASH Annual Meeting and Exposition):5.
Lan KKG, Hu P, Proschan M. A Conditional Power Approach to the Evaluation of Predictive 
Power. Statistics in Biopharmaceutical Research 2012;1 (2):131-6.
Sallman DA, Asch A, Al-Malki M, Lee D, Garcia-Manero G, Donnellan W, et al. Tolerability 
and Efficacy of the First-in-Class Anti-CD47 Antibody Magrolimab Combined 
With Azacitidine in MDS and AML Patients: Phase 1b Results [Presentation]. 
American Society of Clinical Oncology (ASCO) Annual Meeting Virtual; 2020. 


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11.
SOFTWARE
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA.


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12.
SAP REVISION
Revision Date
(DD MMM YYYY)
Section
Summary of Revision
Reason for Revision


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13.
APPENDICES
Appendix 1.
Schedule of Assessments
Appendix Table 1.
Schedule of Assessments – Screeninga
Study 
Assessment
Day −30 to −1
Bone marrow aspirate for central assessment of TP53 mutation statusb
X
Informed consenta
X
Demographics
X
Medical and cancer history
X
Serum pregnancy testc
X
CBC with differential, platelets, reticulocytes, blasts
X
Serum or plasma chemistry
X
PT, INR, and aPTT (or PTT)
X
Blood phenotyping or genotyping,f type, and screen (ABO/Rh), DAT
X
Urinalysis
X
Peripheral blood for MRD assessmentd
X
Bone marrow biopsy and aspirate for blast evaluation, correlative studies, 
cytogenetics, and MRD assessmentb,e
X
Peripheral blood smear (for blasts)e
X
ECOG performance status
X
Vital signs, height, and weight
X
Complete physical examination
X
HBV, HCV, and HIV
X
12-lead ECG (single)
X
Echocardiogram or MUGA (for patients appropriate for intensive therapy)
X
Adverse events related to protocol-mandated procedures
X
Prior and concomitant medications
X
Eligibility criteria
X
Randomization a 
X
ABO = any of the 4 blood groups A, B, AB, and O comprising the ABO system; aPTT = activated partial thromboplastin time; 
CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology 
Group; FSH = follicle-stimulating hormone; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency 
virus; MRD = minimal residual disease; MUGA = multigated acquisition (scan); PT/INR = prothrombin time/international 
normalized ratio; PTT = partial thromboplastin time; RBC = red blood cells; Rh = rhesus factor
a
Screening must be completed before randomization. Randomization must occur within 30 days of signing informed consent. 
The first dose of study treatment must be given within 72 hours after randomization.


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b
Bone marrow biopsy and aspirate for blast evaluation, correlative studies, cytogenetics and to assess TP53 mutational status 
may take place as a prescreening assessment and will require an additional consent form. In that case, the MRD assessment 
will not be required.
c
Screening pregnancy test may be used as the Cycle 1 Day 1 test if performed within 72 hours prior to first dose; additional 
guidance is provided in Protocol Amendment 5 Section 6.4.1. FSH test is required for female patients who are < 54 years 
old who are not on hormonal contraception and who have stopped menstruating for ≥ 12 months but do not have 
documentation of ovarian hormonal failure.
d
Peripheral blood sample for MRD assessment must be collected prior to the first dose of study treatment at the latest.
e
A trephine (biopsy) is to be collected for baseline. This procedure must be performed prior to the first dose of study 
treatment at the latest. An aspirate sample will be collected for blast evaluation, MRD assessment, correlative studies, and 
biobanking. Bone marrow aspirate samples are to be obtained at the time of bone marrow (trephine) biopsy. Conventional 
cytogenetics to be tested per institutional standards. Peripheral blood smear for blasts are to be collected along with bone 
marrow aspirate/biopsy.
f
ABO/Rh type, antibody screen, DAT, and extended RBC phenotyping (including minor antigens such as CcDEe, Cw, 
MNSs, Kk, FyaFyb, and JkaJkb) must be performed for each patient. RBC genotyping instead of extended RBC 
phenotyping is acceptable for any patient. RBC genotyping (instead of an extended RBC phenotyping) must be performed if 
a patient received any RBC or whole blood transfusion within the previous 3 months (unless the laboratory has availability 
for special techniques for performing phenotyping for patients with a recent transfusion). Results must be available before 
the first dose of magrolimab.


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Appendix Table 2.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) and Venetoclax + 
Azacitidine Regimens
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8 11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7 15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
PRO Assessmentb
X
X
X
Serum or Urine 
Pregnancy Testc 
X
X
X
CBC with 
Differential, 
Platelets, 
Reticulocytes, 
Blastsd,e
X
X
X
X X
X
X
X
X
X
X X
X
X
X
X
X
X
X
Haptoglobin and 
LDHd
X
X
X
X
X
Serum or Plasma 
Chemistryd
Xf Xf Xf Xf
X
X
X
X
X
X
X
Peripheral Blood 
Smear (for General 
Morphology)d,g
X
X
X
Peripheral Blood 
Smear (for Blasts)h
X
X
C4D28, 
C6D28 
then 
Q3C
Buccal Swabi
X


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Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8 11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7 15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Peripheral Blood 
Sample for 
Correlative 
Studiesj
X
X
X
Xk
X
C6D28
Peripheral Blood 
Sample for MRD 
Assessmenth
X
X
C4D28, 
C6D28 
then 
Q3C
Bone Marrow 
Aspirate for 
Cytogenetics, 
MRD Monitoring 
and Response 
Assessment,h,l,m
X
X
C4D28, 
C6D28 
then 
Q3C
Bone Marrow 
Aspirate and 
Biopsy for 
Correlative 
Studiesh
X
C6D28
Vital Signsn
X
X
X X
X
X
X
X X
X
X
X
Weightn
X
X
X
Symptom-directed 
Physical 
Examinationd
X
X
X
X
X


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Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
Visit Window
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8 11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
1
2
3
4
5
6
7
8 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7 15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Adverse Events, 
Concomitant 
Medications 
(Including Blood 
Transfusions)o
X
X
X
X X X X X X
X
X
X
X
X X X X X X X X
X
X
X X X X X X X X
X
Study Treatment Dispensing
Venetoclaxp
X
X
X
Study Treatment Administration
Azacitidineq
X
X
X
X X X X
X
X X X X X X
X X X X X X X
Venetoclaxp,r
X
X
X
X X X X X X
X
X
X
X
X X X X X X X X
X
X
X X X X X X X X
X
C = cycle; CBC = complete blood count; D = day; EOT = end of treatment; EORTC QLQ- European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire -Core Questionnaire; EQ-5D-5L = 5-level EuroQol 5 dimensions; LDH = lactate dehydrogenase; MRD = minimal residual disease; PGIC = Patient Global 
Impression of Change; PGIS = Patient Global Impression of Severity; PRO = patient-reported outcome; Q3C = every 3 cycles; WBC = white blood cell
a
If the patient is cytopenic at Day 28, CBC is to be monitored at least twice per week for 2 weeks or until optimal count recovery is reached (whichever comes first). The best 
CBC result within the ± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood 
count need not be repeated if the prior CBC (including prior Day 28 CBC) is within 3 days of Day 1.
b
Four PRO instruments will be administered in this study: the EORTC QLQ-C30 questionnaire, the EQ-5D-5L, the PGIS, and the PGIC. The patient should complete these 
questionnaires before any other study procedures at required visits. EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC. PGIC is not 
required at Cycle 1 Day 1.
c
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided 
in Protocol Amendment 5 Section 6.4.1.
d
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for CBC, which must be 
performed within 24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous or subcutaneous 
study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
e
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to each magrolimab dose during 
Cycle 1.
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f
To monitor the risk of tumor lysis syndrome during venetoclax ramp-up, blood chemistry is to be collected predose and 6 to 8 hours postdose of venetoclax administration on 
Cycle 1 Day 1, Cycle 1 Day 2, and Cycle 1 Day 3. Blood chemistry on Cycle 1 Day 4 is to be collected 24 hours after the dose of venetoclax given on Cycle 1 Day 3.
g
Peripheral blood smears will be collected at predose and assessed locally.
h
Day 28 assessments can be done on Day 1 of the next cycle if there is no foreseen delay of more than 7 days. Bone marrow response information from Day 28 may be 
required to decide start of the next cycle per dosing modification guidelines in the protocol (Protocol Amendment 5 Section 5.10, and Table 8, Table 9, and Table 11). 
Collection of bone marrow aspirate and biopsy for correlative studies will be allowed within 7 days (rather than a 3-day window).
i
Single sample will be collected on Day 1 or at any time during the study.
j
Samples will be collected predose within 12 hours prior to study treatment administration. 
k
Peripheral blood samples for correlative studies do not need to be repeated at D1, if performed in the past 7 days. Collection of peripheral blood for correlative studies will be 
allowed within 7 days (rather than a 3-day window).
l
Conventional cytogenetics to be tested per institutional standards.
m
An aspirate sample will be collected for response assessment and MRD assessment. Response assessments may be adjusted by up to 1 week prior to Cycle 1 Day 28, and 
Cycle 2 Day 28. After Cycle 2 Day 28, the window is up to 14 days ± from Day 28. Bone marrow results are to be reviewed as required for determining schedule 
modifications.
n
Vital signs will be assessed prior to infusion/injection of each study treatment on the days marked in the table. Weight will be assessed on Day 1 of each cycle. Details are 
provided in Protocol Amendment 5 Section 6.4.5.
o
Collected at all regularly scheduled visits.
p
Venetoclax will be dispensed to the patient on Day 1 of each treatment cycle. 
q
Azacitidine administration should be completed at least 1 hour before magrolimab administration on days when both drugs are administered. Azacitidine may be administered 
on an alternative schedule such as Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days. 
r
Venetoclax is administered daily. Please refer to Protocol Amendment 5 Section 5.4.


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Appendix Table 3.
Magrolimab Administration and Associated Assessment Schedule-Treatment Period
Visit Window (Days)
Nonea
± 3a
Day
1 
2
4 
8
11
15
Weekly  5 
Every 2 Weeks 
Vital signsb
X
X
X
X
X
X
X
Hemoglobinc
Pre and post dose
Pre and post 
dose
PK
Within 
12 hours prior 
to magrolimab 
dosing
Antidrug antibodiese
Within 72 hours 
prior to 
magrolimab 
dosing
Within 12 hours 
prior to 
magrolimab dosing 
for 2nd weekly 
dose
Within 12 hours 
prior to magrolimab 
dosing before 1st, 
5th, 9th, 15th and 
21st biweekly 
maintenance doses 
of 30 mg/kgd
Magrolimab Administration
Premedication
X
X
X
X
Magrolimabg
X
X
X
X
X
X
X
ADA = antidrug antibodies; PK = pharmacokinetic(s)
a
In cases of magrolimab repriming/re-escalation following a treatment delay (Protocol Amendment 5 Section 5.8.1), follow magrolimab schedule of assessment and 
administration for repriming Appendix Table 6. 
b
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Protocol Amendment 5 Section 6.4.5.
c 
Hemoglobin must be performed within 24 hours prior to magrolimab dosing on Days 1 and 4 to ensure hemoglobin is ≥ 9 g/dL. Patients who do not meet these criteria must 
be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 magrolimab doses. Hemoglobin must be checked again 3 to 6 hours after the 
initiation of the first and second doses of magrolimab during initial treatment (see Protocol Amendment 5 Section 5.8).
d
On the first day of the biweekly maintenance dose, an additional sample for postdose PK will be collected at 1 hour (± 15 minutes) after the end of infusion of magrolimab.
e
When collected on the day of study treatment dosing, the blood sample for ADA must be collected at the same time as the predose PK sample. Antidrug antibodies will not be 
collected on Day 8.
f
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment and in case of reintroduction with repriming. Premedication for 
subsequent doses may be continued based on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions. In the case of a Grade 3 
infusion related reaction, a premedication regimen for subsequent doses is required (Protocol Amendment 5 Section 7.8.1.2).
g
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours 
(± 30 minutes) for infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion for priming, repriming/re-escalation, and maintenance doses during the first 4 
weeks. For magrolimab dosing, refer to Protocol Amendment 5 Table 2.


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Appendix Table 4.
Schedule of Assessments - Treatment Period for the 7 + 3 Regimen
Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs 
First
At 
Count 
Recoveryb
PRO Assessmentc
X
X
Serum or urine 
Pregnancy Testd 
X
X
CBC with Differential, 
Platelets, 
Reticulocytes, Blastse,f
X
X
X
X
X
X
X
X
X
X
12-lead ECG (single)
Xg
Echocardiogram or 
MUGA 
Xg
Haptoglobin and 
LDHe
X
X
X
Serum or Plasma 
Chemistrye
X
X
X
X
X
X
X
X
Peripheral Blood 
Smear (for General 
Morphology)e,h
X
X
X
Peripheral Blood 
Smear (for Blasts)b, i
Xi
X
X
Buccal Swabk
X
Peripheral Blood 
Sample for Correlative 
Studiesl
X
Xj
X
Consolidation 
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Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs 
First
At 
Count 
Recoveryb
Peripheral Blood 
Sample for MRD 
Assessmentb
 
Xj
X 
X
Bone Marrow Aspirate 
for Cytogenetics, 
MRD Monitoring and 
Response 
Assessmentb,i,m
Xj
X
X
Bone Marrow Aspirate 
and Biopsy for 
Correlative Studiesn
X
Consolidation 
C4 only
Vital Signso
X
X
X
X
X
X
X
X
X
X
X
X
X
Weighto
X
X
Symptom-Directed 
Physical Examinatione
X
X
X
X
X
X
Adverse Events, 
Concomitant 
Medications 
(Including Blood 
Transfusions)p
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X


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Induction Cycle(s)
Consolidation Cycles
(up to 4 cycles)
Visit Window 
None
± 3a Days
± 3a Days
Cycle Day
1
2
3
4
5
6
7
15
21 
and Twice 
Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs First
At 
Count 
Recoveryb
1
3
5
21 
and Weekly 
Thereafter 
Until Count 
Recovery or 
Day 56, 
Whichever 
Occurs 
First
At 
Count 
Recoveryb
Study Treatment Administration
7 + 3
Daunorubicin or 
Idarubicinq
X
X
X
Cytarabiner
X
X
X
X
X
X
X
5 + 2
Daunorubicin or 
Idarubicinq
X
X
Cytarabiner
X
X
X
X
X
Consolidation
Cytarabine (HiDac)s
X
X
X
C = cycle; CBC = complete blood count; ECG = electrocardiogram; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life 
Questionnaire-Core Questionnaire; EQ-5D-5L = 5-level EuroQol 5 dimensions; LDH = lactate dehydrogenase; MRD = minimal residual disease; MUGA = multigated acquisition 
(scan); PGIC = Patient Global Impression of Change; PGIS = Patient Global Impression of Severity; PRO = patient-reported outcome; WBC = white blood cell
a
± 3-day visit window does not apply to specimen collection during induction for correlative studies, nor to study drug administration.
b
Response assessments will be performed as described in Protocol Amendment 5 Table 13.
c
Four PRO instruments will be administered in this study: the EORTC QLQ-C30 questionnaire, the EQ-5D-5L, the PGIS, and the PGIC. The patient should complete these 
questionnaires before any other study procedures at required visits. EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC. PGIC is not 
required at Cycle 1 Day 1. 
d
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided 
in Protocol Amendment 5 Section 6.4.1.
e
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment; thereafter, pretreatment 
assessments are to be collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or 
subcutaneous study drugs thereafter.
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f
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to initiation of study treatment.
g
At the end of Consolidation Cycles 1 and 4.
h
Peripheral blood smears will be collected at predose and assessed locally.
i 
A bone marrow sample is to be collected for response assessment. An aspirate sample will be collected for response assessment and MRD assessment. Response assessments 
may be adjusted by ± 5 days for Cycle 1 (Day 15). The window for post consolidation or post transplantation is ± 14 days. 
j
Response assessment (including bone marrow biopsy/aspirate) at C1D15 should be performed only after 7 + 3 induction to determine if second induction with 5 + 2 is needed. 
After 5 + 2 induction, there is no need to perform Day 15 bone marrow assessment and bone marrow assessment should be performed only at count recovery (not beyond 
42 days after the initiation of 5 + 2).
k
Single sample to be collected on Day 1 of the first induction cycles or at any time during the study.
l
Samples will be collected predose within 12 hours prior to study treatment administration. Collection of peripheral blood for correlative studies will be allowed within 7 days 
(rather than a 3-day window).
m
Conventional cytogenetics to be tested per institutional standards.
n
Collection of bone marrow aspirate and biopsy for correlative studies will be allowed within 7 days (rather than a 3-day window).
o
Vital signs will be assessed prior to infusion of each study treatment. Weight will be assessed on Day 1 of each cycle. Details are provided in Protocol Amendment 5 
Section 6.4.5.
p
Collected at all regularly scheduled visits.
q
For 7 + 3 regimen, daunorubicin or idarubicin is administered on Days 1-3 and for 5 + 2 regimen, daunorubicin or idarubicin is administered on Days 1 and 2.
r
For 7 + 3 regimen, cytarabine is administered on Days 1-7 and for 5 + 2 regimen, cytarabine is administered on Days 1-5.
s
Cytarabine (HiDAC) is administered every 12 hours in the consolidation cycles.      


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Appendix Table 5.
Schedule of Assessments – Post treatment
End of Treatment 
Visit
Safety Follow-up 
Visit/Call
(Telephone)a
Safety 
Follow-up 
Visit/Call
(Telephone)a
Long -term 
Follow-up
Long-term Follow-
up After SCT
Survival 
Follow-up
Within 7 Days 
After Last Dose or 
EOT Decision, 
Whichever Occurs 
Later
30 Days
After Last Dose
70 Days
After Last 
Doseb
Until Disease 
Progression or 
Start of New 
Anti-AML 
Therapyc, 
Whichever 
Occurs Firstd
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapyc, 
Whichever Occurs 
Firstd
Every 
2 Months 
Until Death 
or End of 
Study
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 Days 
± 14 days
Serum or Urine Pregnancy Teste
Q4W
CBC with Differential, Platelet Count, 
Reticulocytes, Blasts
X
Q12W
Q12W
Serum or Plasma Chemistry
X
Peripheral Blood for Correlative Studiesf
X
Pharmacokinetics
X
Antidrug Antibodies 
X
Bone Marrow Aspiratei for MRD Monitoring, 
Response Assessmentg, and Cytogeneticsh
Xi
Q12W
Q12W
Peripheral Blood Smear (for Blasts)g
Xe
Q12W
Q12W
12-lead ECG (single) (for patients treated with 7 + 3)j
X
Q12W
Q12W
Echocardiogram or MUGA (for patients treated with 
7 + 3)j
X
Q12W
Q12W
ECOG performance status
X
Vital Signs 
X
Symptom-Directed Physical Examination
X
PRO Assessmentk
X
Q12W
Adverse Eventsl
X
X
X
Concomitant Medications
X
X
X


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End of Treatment 
Visit
Safety Follow-up 
Visit/Call
(Telephone)a
Safety 
Follow-up 
Visit/Call
(Telephone)a
Long -term 
Follow-up
Long-term Follow-
up After SCT
Survival 
Follow-up
Within 7 Days 
After Last Dose or 
EOT Decision, 
Whichever Occurs 
Later
30 Days
After Last Dose
70 Days
After Last 
Doseb
Until Disease 
Progression or 
Start of New 
Anti-AML 
Therapyc, 
Whichever 
Occurs Firstd
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapyc, 
Whichever Occurs 
Firstd
Every 
2 Months 
Until Death 
or End of 
Study
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 Days 
± 14 days
New Anti-AML Therapym
X
X
X
X
X
X
Survival Follow-up
X
AE = adverse event; CBC = complete blood count; CR = complete remission; CRh = complete remission with partial hematologic recovery; CRi = complete remission with 
incomplete count recovery; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire-Core Questionnaire; EOT = end of treatment; MLFS = morphologic leukemia-free state; MUGA = multigated acquisition (scan); 
PGIS/PGIC = Patient Global Impression of Severity/Patient Global Impression of Change; PR = partial remission; PRO = Patient Report Outcome; Q4W = every 4 weeks; 
Q12W = every 12 weeks; SAE = serious adverse event; SCT = stem cell transplant; SOC = standard of care
a
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site.
b
For patients who do not initiate new anti-AML therapy after the last dose. See Protocol Amendment 5 Section 6.4.11. for adverse event reporting details.
c
For patients who start new anti-AML therapy (other than SCT) before a relapse, efficacy status (done as SOC) will be collected until relapse. 
d
Disease progression includes relapse after CR/CRi/CRh or disease progression after PR, stable disease, or MLFS.
e
Pregnancy tests should be taken at monthly intervals until end of contraception requirement.
f
Peripheral blood for correlative studies should not be repeated at EOT if done at the end of the Consolidation Cycle 4.
g
Response assessment at EOT is required at last dose or EOT decision (± 14 days) and is not required if performed within the last 30 days or if progressive disease has been documented 
or start of new anti-AML therapy, whichever comes first. (SCT and maintenance therapy are not considered new anti-AML therapy.) 
h
Conventional cytogenetic testing (per institutional standards) is required for all patients.
i
Bone marrow aspirate and biopsy for correlative studies is required at EOT if not done at the end of the Consolidation Cycle 4.
j
Only for patients undergoing treatment with 7 + 3 intensive chemotherapy. ECG and echocardiogram/MUGA should not be repeated at EOT visit if performed in the past 
4 weeks.
k
EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC.
l
Report all AEs through the safety follow-up visit/call, and any treatment-related SAEs thereafter.
m
Collect data for the first new anti-AML therapy following the last dose of study treatment.
      


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Appendix Table 6.
Schedule of Assessments - Repriming/Reescalation Cycle (Required after Magrolimab Delays 
of >4 Weeks)
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 2 weeks 
OR
57, then every 2 weeksb
Safety
CBC with differential, platelets, reticulocytesc,d
X
X
X
X
X
X
X
Haptoglobin and LDHc
X
X
X
X
Chemistryc
X
X
X
X
X
Peripheral blood smear for general morphologyc,e
X
X
X
Vital signsf
X
X
X
X
X
X
X
Weight
X
Symptom-directed physical examinationc
X
X
X
Adverse eventsg
Concomitant medicationsg
PK/Immunogenicity
PKj
X
X
Xj
Xj
Antidrug antibodiesk
X
Xk
Xk
Magrolimab Administration
Premedicationl
X
X
X
X
Magrolimabm
X
X
X
X
X
X
X
ADA = antidrug antibodies; CBC = complete blood count; EOT = end of treatment; LDH = lactate dehydrogenase; PK = pharmacokinetic(s); Q4W = every 4 weeks; WBC = white 
blood cell
a
Any other visit window specifications for individual assessments should be applied.
b
In case the repriming occurs during the first 4 weeks of magrolimab treatment, patient should receive magrolimab 30 mg/kg weekly × 5 after receiving Day 15 dose. All Day 22 safety 
assessments should be completed weekly x 5. One week after the 5th weekly dose, dosing of magrolimab will be 30 mg/kg Q2W.
. 


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c
Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of any study treatment. Pretreatment laboratory assessments are to be 
collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study 
drugs thereafter.
d
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during first 
4 weeks of repriming. In the case of repriming, before the administration of the 2 first doses of magrolimab, hemoglobin should be ≥ 9 g/dL. Transfusions are allowed to meet this 
hemoglobin level.
e
Peripheral blood smears for general morphology will be collected predose and assessed locally.
f
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Protocol Amendment 5 Section 6.4.5.
g
Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments 
are not scheduled.
j
Samples will be collected within 72 hours before the first dose of magrolimab and within 12 hours before subsequent doses of magrolimab. In addition to Day 1, and Day 8, 
predose samples will also be collected before the Day 29 dose (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the 1st, 
5th, 9th, 15th, and 21st biweekly maintenance doses of 30 mg/kg, respectively, and at EOT. On the first day of the biweekly maintenance dose, an additional sample for 
postdose PK will be collected at 1 hour (± 15 minutes) after the end of infusion of magrolimab.
k
When collected on the day of magrolimab dosing, the blood sample for ADA must be collected at the same time as the predose PK sample. ADA samples will be collected at 
predose on Day 1 and Day 29 (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the 1st, 5th, 9th, 15th and 21st biweekly 
maintenance doses of 30 mg/kg, respectively, and at EOT.
l
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedication for 
subsequent cycles may be continued based on the treating physician’s clinical judgment and the presence/severity of prior infusion related reactions. In the case of a Grade 3 
infusion related reaction, a premedication regimen for subsequent doses is required (Protocol Amendment 5 Section 7.8.1.2).
m
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses, and then 2 hours (± 30 minutes) for 
infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to Protocol Amendment 5 
Table 2.


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Appendix Table 7.
Schedule of Assessments - Treatment Period for Azacitidine (Experimental Arm) and Venetoclax + 
Azacitidine Regimens, in the Event the Study Meets Futility, and the Sponsor Decides to Terminate the 
Study
Visit Window
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8 11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7
8 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7 15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Serum or Urine 
Pregnancy Testb,
X
X
X
CBC with 
Differential, 
Platelets, 
Reticulocytes, 
Blastsc, d
X
X
X
X X
X
X
X
X
X
X X
X
X
X
X
X
X
X
Serum or Plasma 
Chemistrye
Xe Xe Xe Xe
X
X
X
X
X
X
X
Bone Marrow 
Aspirate for 
Response 
Assessment,f, g, h
X
X
C4D28, 
C6D28 
then 
Q3C
Vital Signsi
X
X
X X
X
X
X
X X
X
X
X
Weighti
X
X
X
Symptom-directed 
Physical 
Examinationc
X
X
X
X
X


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Visit Window
Cycle (28-day cycles)
Cycle 1
Cycle 2
Cycle 3+
None
± 3 Days
± 3 Days
± 3 Days
Cycle Day
1
2
3
4
5
6
7
8 11 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7
8 15 22 28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a 1
2
3
4
5
6
7 15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)a
Adverse Events, 
Concomitant 
Medications 
(Including Blood 
Transfusions)j
X
X
X
X X X X X X
X
X
X
X X X X X X X X X
X
X
X X X X X X X X
X
Study Treatment Dispensing
Venetoclaxk
X
X
X
Study Treatment Administration
Azacitidinel
X
X
X
X X X X
X X X X X X X
X X X X X X X
Venetoclaxk, m
X
X
X
X X X X X X
X
X
X
X X X X X X X X X
X
X
X X X X X X X X
X
C = cycle; CBC = complete blood count; D = day; MRD = minimal residual disease; Q3C = every 3 cycles; SOC = standard of care; WBC = white blood cell
a.
If the patient is cytopenic at Day 28, CBC is to be monitored at least twice per week for 2 weeks or until optimal count recovery is reached (whichever comes first). The best 
CBC result within the ± 2-week window is to be used for the response assessment, with the date of response being the date of the bone marrow assessment. Complete blood 
count need not be repeated if the prior CBC (including prior Day 28 CBC) is within 3 days of Day 1.
b.
Screening pregnancy test may be used if performed within 72 hours of first dose; pregnancy tests will be conducted on Day 1 of every cycle; additional guidance is provided 
in Protocol Amendment 5 Section 6.4.1.
c.
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hours before administration of any study treatment except for CBC, which must be 
performed within 24 hours prior to magrolimab dosing. Thereafter, pretreatment assessments are to be collected within 24 hours prior to any intravenous or subcutaneous 
study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study drugs thereafter.
d.
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 ×  103/µL prior to each magrolimab dose during 
Cycle 1.
e.
To monitor the risk of tumor lysis syndrome during venetoclax ramp-up, blood chemistry is to be collected predose and 6 to 8 hours postdose of venetoclax administration on 
Cycle 1 Day 1, Cycle 1 Day 2, and Cycle 1 Day 3. Blood chemistry on Cycle 1 Day 4 is to be collected 24 hours after the dose of venetoclax given on Cycle 1 Day 3.
I I I I I I I I I I I I I 
I I I I I I I I I I I I 
I I I I I I I I I 
1111111111111 
111111111111 
111111111 


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f.
Bone marrow assessments may continue locally as per the schedule outlined in Protocol Amendment 5 Table 13 and Table 26 or as per investigator discretion. MRD testing 
will not be required nor performed by the central laboratory but may be done locally per SOC. If continuing response assessments per Protocol Amendment 5 Table 13 and 
Table 26, Day 28 assessments can be done on Day 1 of the next cycle if there is no foreseen delay of more than 7 days. Bone marrow response information from Day 28 may 
be used to decide start of the next cycle per dosing modification guidelines in the protocol (Protocol Amendment 5 Section 5.10, and Table 8, Table 9, and Table 11).
g.
Conventional cytogenetics testing may be performed locally per SOC but will not be required. 
h.
If continuing assessments per Protocol Amendment 5 Table 13 and Table 26, response assessments may be adjusted by up to 1 week prior to Cycle 1 Day 28, and Cycle 2 
Day 28. After Cycle 2 Day 28, the window is up to 14 days ± from Day 28. Bone marrow results should be reviewed as required for determining schedule modifications.
i.
Vital signs will be assessed prior to infusion/injection of each study treatment on the days marked in the table. Weight will be assessed on Day 1 of each cycle. Details are 
provided in Protocol Amendment 5 Section 6.4.5.
j.
Collected at all regularly scheduled visits. In the event the study meets futility, and the sponsor decides to terminate the study, AEs that occur following initiation of study 
medication, regardless of cause or relationship, will be collected until 30 days (± 7 days) after last administration of study drug and reported on the eCRFs as instructed.
k.
Venetoclax will be dispensed to the patient on Day 1 of each treatment cycle.
l.
Azacitidine administration should be completed at least 1 hour before magrolimab administration on days when both drugs are administered. Azacitidine may be administered 
on an alternative schedule such as Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience as long as the 7 doses of azacitidine of the cycle are 
administered within 9 consecutive days. 
m.
Venetoclax is administered daily. Please refer to Protocol Amendment 5 Section 5.4.


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Appendix Table 8.
Magrolimab Administration and Associated Assessment Schedule-Treatment Period, in the Event the 
Study Meets Futility, and the Sponsor Decides to Terminate the Study 
Visit Window (Days)
Nonea
± 3a
Day
1 
2
4 
8
11
15
Weekly  5 
Every 2 Weeks 
Vital signsb
X
X
X
X
X
X
X
Hemoglobinc
Pre and post dose
Pre and post 
dose
Magrolimab Administration
Premedicationd
X
X
X
X
Magrolimabe
X
X
X
X
X
X
X
a.
In cases of magrolimab repriming/re-escalation following a treatment delay (Protocol Amendment 5 Section 5.8.1), follow magrolimab schedule of assessment and 
administration for repriming (Appendix Table 6). 
b.
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Protocol Amendment 5 Section 6.4.5.
c.
Hemoglobin must be performed within 24 hours prior to magrolimab dosing on Days 1 and 4 to ensure hemoglobin is ≥ 9 g/dL. Patients who do not meet these criteria must 
be transfused and have their hemoglobin rechecked to meet 9 g/dL prior to each of the first 2 magrolimab doses. Hemoglobin must be checked again 3 to 6 hours after the 
initiation of the first and second doses of magrolimab during initial treatment (see Protocol Amendment 5 Section 5.8).
d.
Premedication is required prior to the administration of the first 4 doses of magrolimab and in case of reintroduction with repriming. Premedications should include oral 
acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg or comparable regimen. For patients who do not experience an 
IRR with the first 2 doses of magrolimab, steroid pretreatment can be discontinued at investigators’ discretion. Patients who experience IRRs with the first 2 doses of 
magrolimab should continue premedication with corticosteroids prior to subsequent doses at the investigator’s discretion. (Protocol Amendment 5 Sections 5.9 and 7.8.1.2).
e.
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab, and then 2 hours 
(± 30 minutes) for infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion for priming, repriming/re-escalation, and maintenance doses during the first 
4 weeks. For magrolimab dosing, refer to Protocol Amendment 5 Table 2.


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Appendix Table 9.
Schedule of Assessments – Posttreatment, in the Event the Study Meets Futility, and the Sponsor Decides 
to Terminate the Study
End of Treatment Visit
Safety Follow-up Visit/Call
(Telephone)
Within 7 Days After Last Dose or EOT Decision, 
Whichever Occurs Later
30 Days
After Last Dose
Visit Window
± 7 Days
± 7 Days
Serum or Urine Pregnancy Testa
Q4W
CBC with Differential, Platelet Count, 
Reticulocytes, Blasts
X
Serum or Plasma Chemistry
X
Bone Marrow Aspirate for Response Assessmentb, c
X
ECOG performance status
X
Vital Signs 
X
Symptom-Directed Physical Examination
X
Adverse Eventsd, e
X
X
Concomitant Medications
X
X
AE = adverse event; CBC = complete blood count; ECOG = Eastern Cooperative Oncology Group; EOT = end of treatment; MRD = minimal residual disease; Q4W = every 
4 weeks; SAE = serious adverse event; SCT = stem cell transplant; SOC = standard of care
a.
Pregnancy tests should be taken at monthly intervals until end of contraception requirement (Protocol Amendment 5 Appendix 5).
b.
Response assessment at EOT may be performed locally at last dose or EOT decision (± 14 days). MRD testing will not be required nor performed by the central laboratory but may 
be done locally per SOC.
c.
Conventional cytogenetic testing may be performed per SOC but is not required.
d.
Report all AEs through the safety follow-up visit/call. SAEs that occur after the 30 days (± 7 days) posttreatment follow-up visit may be reported if deemed relevant to the use 
of study drug by the investigator. Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment 
visits, even when other assessments are not scheduled. In the event the study meets futility and the sponsor decides to terminate the study, AEs and concomitant medications 
will be collected until 30 days (± 7 days) after last administration of study drug and reported on eCRFs as instructed. Post-study anti-AML therapy status will not be collected 
for patients discontinuing study treatment in the event of study termination due to futility.
e.
If the patient experiences a treatment-related AE or an SAE (regardless of attribution), the patient must be asked to come to the site. In the event the study meets futility, and 
the sponsor decides to terminate the study, SAEs that occur after the 30 days (± 7 days) posttreatment follow-up visit may be reported if deemed relevant to the use of study 
drug by the investigator.


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Appendix Table 10. Schedule of Assessments - Repriming/Re-escalation Cycle (Required after Magrolimab Delays 
of > 4 Weeks), in the Event the Study Meets Futility, and the Sponsor Decides to Terminate the Study
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 2 weeks 
OR
57, then every 2 weeksb
Safety
CBC with differential, platelets, reticulocytesc,d
X
X
X
X
X
X
X
Chemistryc
X
X
X
X
X
Vital signse
X
X
X
X
X
X
X
Weight
X
Symptom-directed physical examinationc
X
X
X
Adverse eventsf
Concomitant medicationsf
Magrolimab Administration
Premedicationg
X
X
X
X
Magrolimabh
X
X
X
X
X
X
X
CBC = complete blood count; Q2W = every 2 weeks; WBC = white blood cell
a.
Any other visit window specifications for individual assessments should be applied.
b.
In case the repriming occurs during the first 4 weeks of magrolimab treatment, patient should receive magrolimab 30 mg/kg weekly × 5 after receiving Day 15 dose. All Day 22 safety 
assessments should be completed weekly × 5. One week after the 5th weekly dose, dosing of magrolimab will be 30 mg/kg Q2W.
c.
Pretreatment assessments for the initial dose may be collected up to 72 hours before administration of any study treatment. Pretreatment laboratory assessments are to be 
collected within 24 hours prior to any intravenous or subcutaneous study drugs during the first 2 weeks and within 72 hours prior to any intravenous or subcutaneous study 
drugs thereafter.
d.
Additional samples for CBC may be collected outside of the protocol-specified time points to ensure a WBC level ≤ 20 × 103/µL prior to each magrolimab dose during first 
4 weeks of repriming. In the case of repriming, before the administration of the 2 first doses of magrolimab, hemoglobin should be ≥ 9 g/dL. Transfusions are allowed to meet this 
hemoglobin level.
e.
Vital signs will be assessed prior to administration of magrolimab. Details are provided in Protocol Amendment 5 Section 6.4.5.
f.
Adverse events and concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments 
are not scheduled. In the event the study meets futility, and the sponsor decides to terminate the study, AEs and concomitant medications will be collected until 30 days 
(± 7 days) after last administration of study drug and reported on eCRFs as instructed. Post-study anti-AML therapy status will not be collected for patients discontinuing 
study treatment in the event of study termination due to futility.


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g.
Premedication for magrolimab is required prior to the administration of the first 4 doses of study treatment in case of reintroduction with repriming. Premedications should 
include oral acetaminophen 650 to 1000 mg, oral or IV diphenhydramine 25 to 50 mg, and IV dexamethasone 4 to 20 mg or comparable regimen. For patients who do not 
experience an IRR with the first 2 doses of magrolimab, steroid pretreatment can be discontinued at investigators’ discretion. Patients who experience IRRs with the first 
2 doses of magrolimab should continue premedication with corticosteroids prior to subsequence doses at the investigator’s discretion (Protocol Amendment 5 Sections 5.9 
and 7.8.1.2)
h.
Magrolimab should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses, and then 2 hours (± 30 minutes) for 
infusions beyond the first 3 doses. Monitor patients for 1 hour post infusion, during first 4 weeks for repriming. For magrolimab dosing, please refer to Protocol Amendment 5 
Table 2


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Appendix 2.
Details for Futility Interim Analysis
This appendix provides additional details for the planned interim futility analysis of study 
GS-US-546-5857. 
The planned futility interim analysis will be performed after approximately 69 deaths (40% of 
the expected 171 OS events) in the stratum of patients appropriate for non-intensive therapy have 
occurred. The analysis will include a stratified log-rank test for OS in the stratum of patients 
appropriate for nonintensive therapy and will be reviewed by the DMC. A non-binding futility 
rule with a boundary HR = 1.1 will be implemented. The DMC may make a recommendation to 
terminate the study for futility if the observed HR for the OS in patients appropriate for non-
intensive therapy is larger than 1.1. 
Predictive power is defined as a weighted average of the conditional power; the weighting 
function is determined by the sampling distribution of the observed HR based on the data at the 
interim analysis {Lan 2012}. When exactly 69 OS events are observed at the interim and 
assuming a non-informative prior, this futility rule of  an OS HR > 1.1 corresponds to observing 
a predictive power  < 1.7 % in the ITT population of patients appropriate for non-intensive 
therapy.
Appendix Figure 1 presents the operating characteristics of futility rule with the boundary of 1.1 
at the interim of 69 OS events. When the true OS HR in patients appropriate for non-intensive 
therapy is 0.74, the probability of observing HR > 1.1 at the interim analysis is less than 5%. On 
the other hand, when the true hazard ratio is 1, indicating lack of efficacy, the probability of 
observing HR > 1.1 at the interim analysis is 35%.
Appendix Figure 1. Probability of Observing Overall Survival Hazard Ratio >1.1
LL 
0 
:0 
(U 
.0 
0 
0:: 
q 
m 
ci 
ci 
q 
ci 
0.5 
0.6 
0.7 
0.8 
0.9 
1.0 
1.1 
1.2 
True Overall Survival Hazard Ratio 


GS-US-546-5857-SAP-Final Analysis
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Biostatistics eSigned
08-May-2024
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Global Development
Lead (GDL) eSigned
08-May-2024
18:00:51
PPD
PPD-