Clinical trial NCT05079230
Conditions: Acute Myeloid Leukemia
Sponsor: Gilead Sciences
Start date: 2022-07-07; Completion date: 2024-04-11
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

Detailed description:

Arms: arm 1: Participants will receive

* magrolimab: 1 mg/kg priming dose on Days 1 and 4; 15 mg/kg on Day 8; and 30 mg/kg on Days 11, 15, and then every week for 5 doses and every 2 weeks thereafter
* venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter
* azacitidine: 75 mg/m\^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle

Each cycle is 28 days. arm 2: Participants will receive

* magrolimab matching placebo: Days 1, 4, 8, 11, and 15, then every week for 5 doses and every 2 weeks thereafter
* venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter
* azacitidine: 75 mg/m\^2 on Days 1-7 or Days 1-5 and 8-9 of each cycle

Each cycle is 28 days.
Interventions: intervention 1: Magrolimab intervention 2: Venetoclax intervention 3: Azacitidine intervention 4: Placebo
Intervention descriptions: intervention 1: Administered intravenously (IV) intervention 2: Tablets administered orally intervention 3: Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV) intervention 4: Administered intravenously (IV)

Protocol documents:
Prot_000.pdf: 
CLINICAL STUDY PROTOCOL
Study Title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study 
Evaluating the Safety and Efficacy of Magrolimab versus Placebo 
in Combination with Venetoclax and Azacitidine in Newly 
Diagnosed, Previously Untreated Patients with Acute Myeloid 
Leukemia Who Are Ineligible for Intensive Chemotherapy
Plain Language Short 
Title:
Study of Magrolimab Versus Placebo in Combination With 
Venetoclax and Azacitidine in Participants With Acute Myeloid 
Leukemia (ENHANCE-3)
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
147229
2021-003434-36
NCT05079230
Indication:
Acute Myeloid Leukemia
Protocol ID:
GS-US-590-6154
Contact Information:
The medical monitor name and contact information will be 
provided on the Key Study Team Contact List.
Protocol Version/Date:
Original:
30 June 2021
Amendment 1:
08 September 2021
Amendment 2:
01 November 2021
Amendment 3:
29 November 2021
Amendment 3.1-FRA
13 December 2021
Amendment 4:
30 March 2022
Amendment 4.1-FRA
30 March 2022
Amendment 5:
27 July 2022
Amendment 6:
10 October 2023
Amendment 7: 15 December 2023
High-level summaries of amendments are provided in 
Appendix 16.
Country-specific 
Requirements:
Country-specific requirements, as applicable, are listed in 
Appendix 15.
(fJ GILEAU 


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, the 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.


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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................3
LIST OF IN-TEXT TABLES .........................................................................................................................................7
LIST OF IN-TEXT FIGURES........................................................................................................................................7
PROTOCOL SYNOPSIS................................................................................................................................................8
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................................20
1.
INTRODUCTION................................................................................................................................................24
1.1.
Background..............................................................................................................................................24
1.1.1.
Acute Myeloid Leukemia......................................................................................................24
1.1.2.
Patients Newly Diagnosed with AML Who Are Ineligible for Intensive 
Induction Chemotherapy.......................................................................................................24
1.2.
Magrolimab .............................................................................................................................................24
1.2.1.
General Information ..............................................................................................................24
1.2.2.
Preclinical Pharmacology and Toxicology............................................................................26
1.2.3.
Clinical Studies of Magrolimab.............................................................................................26
1.3.
Information About Venetoclax, Azacitidine ...........................................................................................38
1.3.1.
Description of Venetoclax.....................................................................................................38
1.3.2.
Description of Azacitidine.....................................................................................................38
1.3.3.
Clinical Data for Venetoclax + Azacitidine ..........................................................................39
1.3.4.
Information About Auxiliary Medicinal Products/Noninvestigational 
Products.................................................................................................................................39
1.4.
Rationale for This Study..........................................................................................................................40
1.5.
Rationale for Dose Selection of Magrolimab..........................................................................................43
1.6.
Risk/Benefit Assessment for the Study ...................................................................................................45
1.7.
Compliance..............................................................................................................................................45
2.
OBJECTIVES AND ENDPOINTS......................................................................................................................46
3.
STUDY DESIGN.................................................................................................................................................49
3.1.
Study Design ...........................................................................................................................................49
3.2.
Study Treatments.....................................................................................................................................49
3.3.
Duration of Treatment .............................................................................................................................50
3.4.
Protocol-Specific Stopping Criteria ........................................................................................................51
3.5.
End of Study............................................................................................................................................53
3.6.
Poststudy Care.........................................................................................................................................53
3.7.
Source Data .............................................................................................................................................53
4.
PATIENT POPULATION ...................................................................................................................................54
4.1.
Number of Patients and Patient Selection ...............................................................................................54
4.1.1.
Patient Replacement ..............................................................................................................54
4.2.
Inclusion Criteria.....................................................................................................................................54
4.3.
Exclusion Criteria....................................................................................................................................56
5.
STUDY DRUGS ..................................................................................................................................................58
5.1.
Randomization, Blinding, and Treatment Codes Access ........................................................................58
5.1.1.
Randomization.......................................................................................................................58
5.1.2.
Blinding .................................................................................................................................58
5.1.3.
Planned Interim Unblinding ..................................................................................................59
5.1.4.
Procedures for Breaking the Blind on Treatment Codes.......................................................59
5.2.
Description and Handling of Magrolimab and Placebo ..........................................................................60


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5.2.1.
Formulation ...........................................................................................................................60
5.2.2.
Packaging and Labeling ........................................................................................................60
5.2.3.
Storage and Handling ............................................................................................................60
5.3.
Description and Handling of Venetoclax ................................................................................................60
5.3.1.
Formulation ...........................................................................................................................60
5.3.2.
Packaging and Labeling ........................................................................................................60
5.3.3.
Storage and Handling ............................................................................................................61
5.4.
Description and Handling of Azacitidine................................................................................................61
5.4.1.
Formulation ...........................................................................................................................61
5.4.2.
Packaging and Labeling ........................................................................................................61
5.4.3.
Storage and Handling ............................................................................................................61
5.5.
Dosage and Administration of Study Drugs............................................................................................61
5.5.1.
Dose and Administration of Magrolimab/Placebo................................................................61
5.5.2.
Dosage and Administration of Azacitidine and Venetoclax .................................................63
5.5.3.
Management of Specific Adverse Events and Dose Modification/Delays 
of Study Drugs.......................................................................................................................65
5.5.4.
Premedication and Prophylaxis .............................................................................................73
5.6.
Prior and Concomitant Medications: Prohibited Concomitant Medications...........................................74
5.6.1.
COVID 19 Vaccine ...............................................................................................................76
5.7.
Accountability for Investigational Medicinal Product ............................................................................76
5.7.1.
Investigational Medicinal Product Return or Disposal .........................................................76
6.
STUDY PROCEDURES......................................................................................................................................77
6.1.
Patient Enrollment and Treatment Assignment.......................................................................................77
6.2.
Pretreatment Assessments .......................................................................................................................77
6.2.1.
Screening Visit ......................................................................................................................77
6.2.2.
Baseline/Day 1 Assessments .................................................................................................79
6.3.
Randomization.........................................................................................................................................79
6.4.
On-Study Treatment Assessments...........................................................................................................79
6.5.
Efficacy Assessments ..............................................................................................................................79
6.5.1.
Bone Marrow Assessments ...................................................................................................80
6.5.2.
Peripheral Blood Smear Assessment.....................................................................................81
6.5.3.
Patient-Reported Outcomes...................................................................................................81
6.6.
Safety Assessments .................................................................................................................................82
6.6.1.
Pregnancy Test ......................................................................................................................82
6.6.2.
Complete Blood Counts ........................................................................................................82
6.6.3.
Type and Screen and Direct Antiglobulin Test .....................................................................83
6.6.4.
Vital Signs .............................................................................................................................83
6.6.5.
Physical Examination ............................................................................................................83
6.6.6.
Electrocardiograms................................................................................................................83
6.6.7.
Echocardiogram or MUGA ...................................................................................................83
6.6.8.
Pulmonary Function Tests.....................................................................................................83
6.6.9.
Adverse Events......................................................................................................................83
6.6.10.
Laboratory Assessments........................................................................................................84
6.6.11.
Concomitant Medications......................................................................................................85
6.7.
Pharmacokinetics Assessments ...............................................................................................................86
6.8.
Immunogenicity Assessments .................................................................................................................86
6.9.
Biomarker Assessments...........................................................................................................................86
6.9.1.
Minimal Residual Disease.....................................................................................................87
6.9.2.
Leukemia Mutation Profiles and Burden ..............................................................................87
6.9.3.
Changes in Immune Effector Cell Composition ...................................................................88
6.9.4.
Changes in Immune Effector Cell Signaling Molecules .......................................................88
6.9.5.
Expression of Prophagocytic and Antiphagocytic Signals by Leukemia 
Cells.......................................................................................................................................88


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6.10.
Posttreatment Assessments......................................................................................................................89
6.11.
Assessments for Early Discontinuation from Study Treatment ..............................................................89
6.11.1.
Criteria for Discontinuation of Study Treatment...................................................................89
6.11.2.
End of Study..........................................................................................................................89
6.12.
Post Treatment Discontinuation Care......................................................................................................89
6.13.
Sample Storage........................................................................................................................................89
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT................................................................................90
7.1.
Definitions of Adverse Events and Serious Adverse Events...................................................................90
7.1.1.
Adverse Events......................................................................................................................90
7.1.2.
Serious Adverse Events.........................................................................................................90
7.1.3.
Study Drugs and Gilead Concomitant Therapy Special Situations Reports .........................91
7.2.
Assessment of Adverse Events and Serious Adverse Events..................................................................92
7.2.1.
Assessment of Causality for Study Drugs, Authorized Auxiliary Medical 
Products, and Procedures ......................................................................................................92
7.2.2.
Assessment of Severity..........................................................................................................93
7.3.
Investigator Reporting Requirements and Instructions ...........................................................................93
7.3.1.
Requirements for Collection Prior to Study Drug Initiation .................................................93
7.3.2.
Adverse Events......................................................................................................................93
7.3.3.
Serious Adverse Events.........................................................................................................93
7.3.4.
Study Drug Special Situations Reports .................................................................................94
7.3.5.
Concomitant Therapy Reports...............................................................................................94
7.4.
Reporting Process for Serious Adverse Events and Special Situation Reports.......................................94
7.4.1.
Serious Adverse Event Reporting Process ............................................................................94
7.4.2.
Special Situations Reporting Process ....................................................................................95
7.5.
Gilead Reporting Requirements ..............................................................................................................96
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................97
7.7.
Abnormal Liver Function Tests...............................................................................................................97
7.8.
Toxicity Management..............................................................................................................................98
7.8.1.
Magrolimab ...........................................................................................................................98
7.8.2.
Venetoclax.............................................................................................................................98
7.8.3.
Azacitidine.............................................................................................................................98
8.
STATISTICAL CONSIDERATIONS.................................................................................................................99
8.1.
Analysis Objectives and Endpoints.........................................................................................................99
8.1.1.
Definition of Primary Efficacy Endpoint ..............................................................................99
8.1.2.
Definition of Secondary Efficacy Endpoints.........................................................................99
8.1.3.
Definition of 
8.2.
Planned Analyses...................................................................................................................................104
8.2.1.
Interim Analyses..................................................................................................................104
8.2.2.
Interim Analysis Communication Plan ...............................................................................106
8.2.3.
Primary Analysis .................................................................................................................106
8.2.4.
Final Analysis......................................................................................................................106
8.3.
Unplanned Analysis...............................................................................................................................107
8.4.
Analysis Conventions............................................................................................................................107
8.4.1.
Analysis Sets .......................................................................................................................107
8.4.2.
Data Handling Conventions ................................................................................................108
8.5.
Demographic and Baseline Characteristics Analysis............................................................................108
8.6.
Efficacy Analysis...................................................................................................................................108
8.6.1.
Analysis of Primary Endpoint .............................................................................................108
8.6.2.
Analysis of Secondary Endpoints........................................................................................109
8.6.3.
Analysis of 
CCI
CCI
CCI-


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8.7.
Safety Analysis......................................................................................................................................109
8.7.1.
Extent of Exposure ..............................................................................................................110
8.7.2.
Adverse Events....................................................................................................................110
8.7.3.
Laboratory Evaluations .......................................................................................................110
8.7.4.
Other Safety Evaluations.....................................................................................................110
8.8.
Pharmacokinetic Analysis .....................................................................................................................110
8.9.
Analysis of Patient-Reported Outcome Data ........................................................................................111
8.10.
Immunogenicity Analysis......................................................................................................................111
8.11.
Biomarker Analysis...............................................................................................................................112
8.12.
Sample Size ...........................................................................................................................................112
8.13.
Data Monitoring Committee..................................................................................................................112
9.
RESPONSIBILITIES.........................................................................................................................................114
9.1.
Investigator Responsibilities .................................................................................................................114
9.1.1.
Good Clinical Practice.........................................................................................................114
9.1.2.
Financial Disclosure ............................................................................................................114
9.1.3.
Institutional Review Board/Independent Ethics Committee Review and 
Approval..............................................................................................................................114
9.1.4.
Informed Consent ................................................................................................................114
9.1.5.
Confidentiality.....................................................................................................................115
9.1.6.
Study Files and Retention of Records .................................................................................115
9.1.7.
Case Report Forms ..............................................................................................................116
9.1.8.
Investigator Inspections.......................................................................................................117
9.1.9.
Protocol Compliance ...........................................................................................................117
9.2.
Sponsor Responsibilities .......................................................................................................................117
9.2.1.
Protocol Modifications ........................................................................................................117
9.2.2.
Study Report and Publications ............................................................................................117
9.3.
Joint Investigator/Sponsor Responsibilities ..........................................................................................118
9.3.1.
Regulatory and Ethical Considerations ...............................................................................118
9.3.2.
Payment Reporting ..............................................................................................................118
9.3.3.
Access to Information for Monitoring.................................................................................118
9.3.4.
Access to Information for Auditing or Inspections .............................................................118
9.3.5.
Study Discontinuation .........................................................................................................118
10.
REFERENCES...................................................................................................................................................119
11.
APPENDICES....................................................................................................................................................123
Appendix 1.
Investigator Signature Page...................................................................................................124
Appendix 2.
Pandemic Risk Assessment and Mitigation Plan ..................................................................125
Appendix 3.
Schedules of Assessment and Treatment Administration .....................................................130
Appendix 4.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria........................................................................142
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................146
Appendix 6.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities ........................................................................................................................150
Appendix 7.
Eastern Cooperative Oncology Group Performance Status...................................................151
Appendix 8.
2017 European LeukemiaNet Risk Stratification by Genetics..............................................152
Appendix 9.
European Organisation for the Research and Treatment of Cancer Quality of Life 
Questionnaire–Core Questionnaire (EORTC QLQ-C30)......................................................153
Appendix 10.
EuroQol (5 Dimensions, 5 levels) Questionnaire (EQ-5D-5L).............................................155
Appendix 11.
Patient Global Impression of Severity (PGIS) and Patient Global Impression of 
Change (PGIC) ......................................................................................................................158


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Appendix 12.
Cockcroft Gault Method for Estimating Creatinine Clearance..............................................160
Appendix 13.
World Health Organization (WHO) Classification of AML (2016) .....................................161
Appendix 14.
Marketing Authorization Status of Study Interventions........................................................162
Appendix 15.
Country-Specific Requirements ............................................................................................163
Appendix 16.
Amendment History ..............................................................................................................168
LIST OF IN-TEXT TABLES
Table 1.
Study 5F9005: Treatment Emergent Adverse Events Reported in > 10% of Subjects 
with First-Line Unfit AML (biomarker unselected) Treated with Magrolimab and 
Azacitidine by Preferred Term ................................................................................................29
Table 2.
Study 5F9005: Treatment Emergent Adverse Events Reported in > 10% of Subjects 
with First-Line TP53-Mutated Unfit AML Treated with Magrolimab and 
Azacitidine by Preferred Term ................................................................................................31
Table 3.
2020-0027: MDACC Investigator Initiated Study: Adverse Events Reported in ≥ 2 
Subjects with AML Treated with Magrolimab + Venetoclax + Azacitidine by 
Preferred Term.........................................................................................................................33
Table 4.
2020-0027: MDACC Investigator Initiated Study: Adverse Events Reported in ≥ 2 
Subjects with TP53 mutated AML Treated with 
Magrolimab + Venetoclax + Azacitidine by Preferred Term..................................................36
Table 5.
Study Objectives and Endpoints..............................................................................................46
Table 6.
Study Treatments.....................................................................................................................50
Table 7.
Repriming Guidelines for Magrolimab/Placebo......................................................................63
Table 8.
Magrolimab/Placebo Dosing Guidance for Planned Surgical Procedures During the 
Study........................................................................................................................................63
Table 9.
Dose Modifications and Delays of Venetoclax and/or Azacitidine for Neutropenia 
and Thrombocytopenia............................................................................................................68
Table 10.
Management of Infusion-Related Reactions ...........................................................................69
Table 11.
Pneumonitis Management Algorithm......................................................................................71
Table 12.
Dose Modification of Azacitidine for Nonhematologic Toxicities.........................................73
Table 13.
Management of Potential Venetoclax Interactions with CYP3A and P-gp Inhibitors............75
Table 14.
Laboratory Analyte Listing (to Be Performed at Screening)...................................................84
Table 15.
Laboratory Analyte Listing (to Be Performed During the Study)...........................................85
Table 16.
Stopping Boundaries for Efficacy Superiority Analysis in OS .............................................104
Table 17.
Definition of Information Fraction........................................................................................105
LIST OF IN-TEXT FIGURES
Figure 1.
Effect of Magrolimab on Anemia, and Mitigation with a Priming/Maintenance 
Dosing Regimen ......................................................................................................................28
Figure 2.
In Vitro Phagocytosis of AML Cells with Magrolimab, Azacitidine and/or 
Venetoclax...............................................................................................................................41
Figure 3.
Magrolimab-Induced In Vitro Phagocytosis of AML Cells Resistant to Venetoclax 
and Azacitidine Cytotoxicity...................................................................................................42
Figure 4.
Magrolimab Synergistically Increases the Efficacy of Venetoclax Plus Azacitidine 
in a Patient-Derived Xenograft Model ....................................................................................43
Figure 5.
Study Schema ..........................................................................................................................49


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
Study Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the 
Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and 
Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia 
Who Are Ineligible for Intensive Chemotherapy
Plain Language Short Title: Study of Magrolimab Versus Placebo in Combination With 
Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia (ENHANCE-3)
IND Number: 147229
EudraCT Number: 2021-003434-36
Clinical Trials.gov Identifier: NCT05079230
Study Centers Planned: Approximately 170 centers, globally
Objectives and Endpoints:
Objective
Endpoint
Primary:
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine in patients with previously untreated acute 
myeloid leukemia (AML) who are ineligible for 
intensive chemotherapy as measured by overall 
survival (OS)
•
OS, 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 + venetoclax + 
azacitidine versus placebo + venetoclax + azacitidine as 
measured by the rate of complete remission 
(CR) + complete remission with partial hematologic 
recovery (CRh) within 6 cycles of treatment
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by the rate of CR within 
6 cycles of treatment
•
To compare the efficacy of magrolimab + venetoclax + 
azacitidine versus placebo + venetoclax + azacitidine as 
measured by event-free survival (EFS)
•
To evaluate the duration of CR + CRh in patients who 
achieved CR or CRh within 6 cycles of treatment
•
Rate of CR + CRh within 6 cycles of 
treatment
•
Rate of CR within 6 cycles of treatment
•
EFS
•
Duration of CR + CRh in patients who 
achieved CR or CRh within 6 cycles of 
treatment
•
DCR in patients who achieved CR within 
6 cycles of treatment
•
Rate of CR/CRhMRD- within 6 cycles of 
treatment
•
Rate of CRMRD- within 6 cycles of treatment
•
Transfusion independence conversion rate


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•
To evaluate the duration of complete remission (DCR) 
in patients who achieved CR within 6 cycles of 
treatment 
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by rate of CR + CRh without 
minimal residual disease (MRD-) within 6 cycles of 
treatment
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by rate of CR without 
minimal residual disease (CRMRD-) within 6 cycles of 
treatment
•
To compare the efficacy of magrolimab + venetoclax + 
azacitidine versus placebo + venetoclax + azacitidine as 
measured by conversion rate of transfusion dependence 
to transfusion independence
•
To compare the efficacy of magrolimab + venetoclax + 
azacitidine versus placebo + venetoclax + azacitidine as 
measured by time to first deterioration (TTD) on the 
global health status/quality of life (GHS/QoL) and the 
physical functioning scales of the European 
Organisation for Research and Treatment of Cancer 
Quality of Life Questionnaire (EORTC QLQ-C30)
•
To assess the safety and tolerability of magrolimab + 
venetoclax + azacitidine versus placebo + venetoclax + 
azacitidine
•
To evaluate the pharmacokinetics (PK) and 
immunogenicity of magrolimab
•
TTD on the GHS/QoL and the physical 
functioning scales of the EORTC QLQ-C30
•
Incidence of treatment-emergent adverse 
events (AEs) and clinical laboratory 
abnormalities during the study 
•
Magrolimab serum concentrations over time
•
Incidence/prevalence rate and magnitude of 
anti-magrolimab antibodies in serum
CCI


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•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by rate of CR + CRi without 
minimal residual disease (MRD-) within 6 cycles of 
treatment
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by EFS (including CR and 
CRh)
•
To compare the efficacy of magrolimab + venetoclax 
+ azacitidine versus placebo + venetoclax + 
azacitidine as measured by hematological 
improvement
•
To evaluate the duration of response (DOR) and the 
duration of CR + CRi achieved within 6 cycles of 
treatment 
•
To evaluate minimal residual disease (MRD) 
negativity in patients with CR + CRh
•
To evaluate minimal residual disease (MRD) 
negativity in patients with CR + CRi
•
To evaluate minimal MRD negativity by flow 
cytometry and next generation sequencing (NGS)
•
To compare the rate of stem cell transplant (SCT) 
between magrolimab + venetoclax + azacitidine 
versus placebo + venetoclax + azacitidine
•
To evaluate 30- and 60-day mortality in patients 
treated with magrolimab + venetoclax + azacitidine 
versus placebo + venetoclax + azacitidine
•
To assess biomarkers of immune cell recruitment and 
immune cell signaling 
•
To assess the mechanism of intrinsic and acquired 
resistance to magrolimab + venetoclax + azacitidine
•
DOR in patients who achieved response 
within 6 cycles of treatment
•
Duration of CR + CRi achieved within 6 
cycles of treatment 
•
Rate of MRD negativity in patients with 
CR + CRi
•
Rate of MRD negativity in patients with 
CR + CRh 
•
Rate of MRD negativity in patients with 
CR + CRi
•
Rate of MRD negativity by flow cytometry 
and NGS, and concordance between methods 
•
Rate of SCT
•
30- and 60-day mortality rate
•
Changes and percentage changes from 
baseline of biomarkers including biomarkers 
of immune cell recruitment or of immune 
cell signaling
•
Biomarkers related to resistance, including 
mutational profile of leukemic clones, and 
immune profile of tumor microenvironment
     
Study Design: This is a Phase 3, randomized, double-blind, placebo-controlled study 
evaluating the safety and efficacy of magrolimab versus placebo in combination with 
venetoclax and azacitidine in newly diagnosed, previously untreated patients with AML who 
are ineligible for intensive chemotherapy. Approximately 432 patients will be randomized in 
1:1 ratio to receive either magrolimab + venetoclax + azacitidine (experimental arm) or placebo 
+ venetoclax + azacitidine (control arm). Randomization will be stratified by 3 factors:
•
age (< 75 years, ≥ 75 years)
•
genetic risk group (favorable/intermediate, adverse, unknown)
•
geographic region (United States [US], outside the US)


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The primary endpoint is OS. Two interim OS analyses will be conducted, the first one after 
121 deaths (40% of the expected 303 deaths), and the second one after 227 deaths (75% of the 
expected 303 deaths) are observed among all patients; the primary OS analysis will be 
conducted after 303 deaths have occurred.
Number of Patients Planned: Approximately 432 patients in total 
Target Population: Patients with untreated AML who are ≥ 18 years of age and ineligible for 
intensive chemotherapy
Duration of Treatment: Cycle length is 28 days and all patients will continue on study treatment 
unless they meet study treatment discontinuation criteria.
Diagnosis and Main Eligibility Criteria:
Inclusion Criteria:
1) Previously untreated patients with histological confirmation of AML by 2016 World Health 
Organization criteria who are ineligible for treatment with a standard cytarabine and 
anthracycline induction regimen due to age, or comorbidity. Patients must be considered 
ineligible for intensive chemotherapy, defined by the following:
a) ≥ 75 years of age
Or
b) ≥ 18 to 74 years of age with at least 1 of the following comorbidities:
i)
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
ii) Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory 
volume in 1 second ≤ 65%
iii) Left ventricular ejection fraction ≤ 50%
Newly diagnosed, 
previously untreated AM L 
patient s who are ineligible 
for intensive chemotherapy 
(based on objective 
criteria) 
Primary Endpoint: 
• 
Overall Su rvival 
1:1 ran domization 
---------
N=216 
Placebo+ venetoclax + azacitidine 
N=216 
Stratifications: 
1. 
Age (<75 years, ~ 75 years) 
2. 
Genetic risk group (favorable/ 
intermediat e, adverse, unknown) 
3. 
Geographic region (US, outside the 
US) 


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iv) Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the 
Cockcroft Gault formula or measured by 24-hour urine collection
v) Hepatic disorder with total bilirubin > 1.5  upper limit of normal (ULN)
vi) Any other comorbidity that the investigator judges to be incompatible with intensive 
chemotherapy that must be approved by the sponsor’s medical monitor before study 
enrollment
2) ECOG performance status:
a) Of 0 to 2 for subjects ≥ 75 years of age
Or
b) Of 0 to 3 for subjects ≥ 18 to 74 years of age
3) 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/placebo dose during 
Cycle 1.
NOTE: Patients can be treated with hydroxyurea and/or leukapheresis prior to 
randomization and throughout the study to reduce the WBC to ≤ 20  103/µL to enable 
eligibility for study drug dosing.
4) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment based on complete 
blood count result.
NOTE: Transfusions are allowed to meet hemoglobin eligibility.
5) Patient has provided informed consent.
6) Patient is willing and able to comply with clinic visits and procedures outlined in the study 
protocol.
7) Male or female, ≥ 18 years of age
8) Patients must have adequate renal function as demonstrated by a creatinine 
clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour 
urine collection.
9) Adequate liver function as demonstrated by:
a) aspartate aminotransferase ≤ 3.0  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 
d) Patients ≥ 18 to 74 years of age may have total bilirubin ≤ 3.0  ULN
10) Pretreatment RBC phenotype or genotype completed (Section 7.8.1).


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11) Male and female patients of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol-specified method(s) of contraception. 
12) Patients must be willing to consent to mandatory pretreatment and on-treatment bone 
marrow assessments (aspirate and trephines). For France-specific requirements regarding 
bone marrow assessments, please see Appendix 15.
Exclusion Criteria:
1) Positive serum pregnancy test 
2) Breastfeeding female
3) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
4) Patients receiving any live vaccine within 4 weeks prior to initiation of study treatments.
5) Prior treatment with any of the following:
a) CD47 or signal regulatory protein alpha-targeting agents
b) Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), 
low-dose cytarabine, and/or venetoclax), excluding hydroxyurea 
NOTE: Patients with prior myelodysplastic syndrome (MDS)/myeloproliferative 
neoplasm (MPN) who have not received prior HMAs or venetoclax or 
chemotherapeutic agents for MDS/MPN may be enrolled in the study. Prior treatment 
with MDS/MPN therapies including, but not limited to lenalidomide, erythroid-
stimulating agents, or similar red blood cell (RBC-), WBC-, or platelet-direct therapies 
or growth factors is allowed for these patients.
6) Current participation in another interventional clinical study 
7) Known inherited or acquired bleeding disorders
8) Patients who have received treatment with strong and/or moderate CYP3A inducers (eg, 
preparations containing St. John’s wort) within 7 days prior to the initiation of study 
treatments
9) Patients 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 and are unwilling to discontinue consumption of these throughout the 
receipt of study drug
10) Patients who have malabsorption syndrome or other conditions that preclude enteral route 
of administration
11) Clinical suspicion of or documented active central nervous system (CNS) involvement with 
AML
12) Patients who have acute promyelocytic leukemia


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13) 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, uncontrolled infection, and 
congestive heart failure New York Heart Association Class III to IV.
14) Known history, diagnosis, or suspicion of Hemophagocytic Lymphohistiocytosis (HLH) 
syndrome.
15) 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.
NOTE: Localized non-CNS radiotherapy, erythroid and/or myeloid growth factors, 
hormonal therapy 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.
16) Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or 
HIV infection in medical history within 3 months of study entry.
17) Active HBV, and/or active HCV, and/or HIV following testing at screening:
a) Patients who test positive for hepatitis B surface antigen and patients who test positive 
for hepatitis B core antibody will require HBV DNA by quantitative polymerase chain 
reaction (PCR) for confirmation of active disease.
b) Patients who test positive for HCV antibody will require HCV RNA quantitative PCR 
for confirmation of active disease.
c) Patients who test positive for HIV antibody will require viral load testing; those who 
have an undetectable viral load in the prior 3 months may be eligible for the study.


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Study Procedures/Frequency:
Following completion of screening and admission assessments, eligible patients will be 
randomized in 1:1 ratio to receive either magrolimab + venetoclax + azacitidine (experimental 
arm) or placebo + venetoclax + azacitidine (control arm).
The study treatments within each arm are as follows:
Dose Schedule 
(Day per 28-day Cycle)
Treatment 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
Azacitidine
75 mg/m2 SC or IVa
Days 1-7 or
Days 1-5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
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  5 doses 
Experimental arm 
(magrolimab + 
venetoclax + 
azacitidine)
Magrolimab 30 mg/kg IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly 30 mg/kg 
dose
Venetoclax 100 mg oral
Day 1
— 
— 
Venetoclax 200 mg oral
Day 2
—
—
Venetoclax 400 mg oral
Day 3 and daily 
thereafter 
Daily
Daily
Azacitidine 
75 mg/m2 SC or IVa
Days 1-7 or
Days 1–5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
Days 1–7 or
Days 1-5 and 8-9
Placebo Administration
Placebo IV
(over 3 hours)
Days 1, 4
Placebo IV
(over 3 hours)
Day 8
Placebo IV
(over 2 hours)
Days 11 and 15, and then QW  5 doses 
Control arm 
(placebo + 
venetoclax + 
azacitidine)
Placebo IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly 
IV = intravenous; QW = every week; Q2W = every 2 weeks; SC = subcutaneous
a
Azacitidine administered per region-specific labeling or within Days 1-9 of a 28-day cycle per protocol recommendation.


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Cycle lengths are 28 days, and all patients will continue on study treatment until disease 
progression, relapse, loss of clinical benefit, unacceptable toxicities or other study treatment 
discontinuation criteria are met. Clinical benefit, as determined by the investigator, can include 
transfusion independence, adequate blood counts, symptomatic improvement, or other criteria 
as determined by the investigator.
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.
Patients will continue follow-up study visits unless they withdraw completely from the study.
All patients who discontinue study treatment for reasons other than death or start of new anti-
AML therapy (except maintenance and SCT) will participate in long-term follow-up for disease 
response unless the patient withdraws consent for such follow-up and withdraws completely 
from study.
In the event one or more components of the study treatment (magrolimab/placebo, azacitidine 
and/or venetoclax) are discontinued, the following combinations are permitted:
•
Magrolimab/placebo + azacitidine
•
Azacitidine (single agent)
•
Venetoclax + azacitidine
The following combinations are not permitted:
•
Magrolimab/placebo (single agent)
•
Venetoclax (single agent)
•
Magrolimab/placebo + venetoclax
If azacitidine is permanently discontinued, the patient must discontinue the remaining study 
treatment. Patients who discontinue study treatment 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, withdrawal of consent, loss to follow-up, 
completion of survival follow-up, or study termination by the sponsor, whichever occurs first. 
Duration of survival follow-up will be limited to 5 years from the end of treatment visit for 
each patient. If a patient discontinues study treatment and does not consent to continued follow-
up, the investigator must not access confidential records that require the patient’s consent. 
However, an investigator may consult public records to establish survival status. 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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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:
Venetoclax 10 mg oral
Venetoclax 50 mg oral
Venetoclax 100 mg oral
In combination with:
Azacitidine 75 mg/m2 IV or SC
Reference Therapy, Dose, and Mode of Administration:
Placebo for Magrolimab IV
In combination with:
Venetoclax 10 mg oral
Venetoclax 50 mg oral
Venetoclax 100 mg oral 
In combination with:
Azacitidine 75 mg/m2 IV or SC
Criteria for Evaluation:
Safety:
Safety will be evaluated by data including the incidence of AEs, clinical laboratory test 
findings, physical examination, and vital signs measurements. Adverse events will be graded 
using National Cancer Institute Common Terminology Criteria for Adverse Events 
(NCI CTCAE) Version 5.0.
Efficacy will be evaluated by OS, CR + CRh rate, CR rate, EFS, duration of CR + CRh, DCR, 
CR/CRhMRD- rate, CRMRD- rate, transfusion independence conversion rate, and GHS/QoL and 
physical functioning scale scores from EORTC QLQ-C30. Assessment of leukemia response in 
AML patients will be conducted using the European LeukemiaNet 2017 recommendations for 
AML and the 2003 and 2006 International Working Group criteria with modifications.
Pharmacokinetics: 
Magrolimab serum drug concentrations will be assessed in the magrolimab + venetoclax + 
azacitidine group based on the sample collection schedule until treatment 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.


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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.
Safety Analysis Set
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.
Efficacy Analysis
Time-to-event endpoints, including OS, EFS, DCR, and duration of CR + CRh, will be 
summarized using Kaplan-Meier estimates, which include median and the proportion of event-
free patients at benchmark timepoints such as 6 months and 12 months. 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 + CRh rate, CR rate, CR/CRhMRD- rate, CRMRD- rate, and 
transfusion independence conversion rate will be compared between the 2 arms using the 
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.
Time to first deterioration, with at least 1 threshold value deterioration from baseline or death, 
on the EORTC QLQ-C30 GHS/QoL scale and TTD on the EORTC QLQ-C30 physical 
functioning scale will 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.
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.


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Interim Analysis
There are two planned interim analyses. 
The first interim futility analysis of OS will be performed when 121 deaths (40% of the 
expected deaths) have occurred, with a non-bounding futility boundary of HR = 1.1. 
The second interim analysis with O’Brien-Fleming boundary for efficacy will be performed 
when 227 deaths (75% of the expected 303 deaths) have occurred. If the null hypothesis of OS 
is not rejected in the interim analysis, the nonbinding futility test with a futility boundary of HR 
= 0.9 will be performed.
Primary Analysis
The primary analysis will be conducted when 303 death events occur.
Sample Size
The study will randomize approximately 432 patients in total into the control arm (placebo + 
venetoclax + azacitidine) and the experimental arm (magrolimab + venetoclax + azacitidine) at 
a 1:1 ratio, determined by formal hypothesis testing performed on the primary efficacy 
endpoint: OS, with family-wise Type I error controlled at 1-sided significance level of 0.025.
It is assumed that administration of magrolimab + venetoclax + azacitidine to study patients 
will result in a median OS of approximately 21 months, improved from a median OS of 
14.7 months in patients treated with placebo + venetoclax + azacitidine. This corresponds to an 
OS HR of 0.7. Assuming 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, 303 events are needed to detect an HR of 0.7 with 86.4% power at a 1-sided 
significance level of 0.025 using a log-rank test. The design includes the first interim analysis 
with a futility test only when 40% of the information (121 deaths) is available, and the second 
interim analysis with a superiority test together with a futility test when 75% of the information 
(227 deaths) is available, and one primary analysis. For the second OS interim analysis and the 
OS primary analysis, the Lan-DeMets alpha spending function with O’Brien-Fleming stopping 
boundary will be used. The futility boundaries for two interim analyses are obtained using a 
Gamma beta-spending function with parameter -5.
With an accrual period of 19 months (with approximately 51% of the patients enrolled during 
the initial 12 months, and the remaining 49% of the patients enrolled during the last 7 months), 
24 months of follow up, and an annual 1.43% dropout rate (5% dropout chance by 43 months 
with time to dropout assuming exponentially distributed time-to-dropout), a total sample size of 
432 patients (216 patients per treatment group) is needed to observe the required 303 events.
This study will be conducted in accordance with the guidelines of Good Clinical Practice, 
including archiving of essential documents.


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
5F9
magrolimab
ABO
any of the 4 blood groups A, B, AB, and O composing the ABO system
ADA
antidrug antibody
AE
adverse event
AML
acute myeloid leukemia
ANC
absolute neutrophil count
aPTT
activated partial thromboplastin time
AxMP
auxiliary medicinal product
AZA
azacitidine
BUN
blood urea nitrogen 
CBC
complete blood count
cCR
cytogenetic complete remission
CD47
cluster of differentiation 47
CI
confidence interval
CLL
chronic lymphocytic leukemia
CMV
cytomegalovirus
CNS
central nervous system
COVID-19
coronavirus disease 2019
CR
complete remission
CRF
case report form
CRh
complete remission with partial hematologic recovery
CRi
complete remission with incomplete hematologic recovery
CRMRD-
complete remission without minimal residual disease
CRMRD+/unk
complete remission with positive or unknown minimal residual disease
CR/CRhMRD-
complete remission or complete remission with partial hematologic recovery without 
minimal residual disease
CRO
contract research organization
CSR
clinical study report
CT
computed tomography
CYP3A
cytochrome P450 enzyme 3A
CXR
chest x-ray
DAT
direct antiglobulin test
DCR
duration of complete remission
DHHS
Department for Health and Human Services
DLT
dose-limiting toxicity
DMC
data monitoring committee
DNA
deoxyribonucleic acid
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group


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eCRF
electronic case report form
EFS
event-free survival
ELN
European LeukemiaNet
EOT
end-of-treatment
EQ VAS
EQ visual analogue scale
EQ-5D
EuroQoL (5 dimensions, 5 levels)
EU
European Union
FDA
Food and Drug Administration
Fc
crystallizable fragment
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GHS/QoL
global health status/quality of life
Gilead
Gilead Sciences/Gilead Sciences, Inc.
GS
glutamine synthetase
HBV
hepatitis B virus
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HLH
Hemophagocytic Lymphohistiocytosis Syndrome
HMA
hypomethylating agent
HR
hazard ratio
HRQoL
health-related quality of life
IA
interim analysis
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
IIS
investigator-initiated study
IND
investigational new drug
INR
international normalized ratio
IPSS-R
International Prognostic Scoring System
IRB
institutional review board
IRR
infusion-related reaction
IRT
interactive response technology
ITT
Intent-to-Treat
IUD
intrauterine device
IV
intravenous
IWG
International Working Group
LDH
lactate dehydrogenase 


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mAb
monoclonal antibody
Macro
macrophage
MDS
myelodysplastic syndrome
MedDRA
Medical Dictionary for Regulatory Activities
MLFS
morphologic leukemia-free state
MNS
any of the blood groups M, N, and S composing the MNS system
MOA
mechanism of action
MRD
minimal residual disease
MTD
MPN
maximum tolerated dose
myeloproliferative neoplasm
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
pharmacodynamics
PDX
patient-derived xenograft
PGIC
Patient Global Impression of Change
PGIS
Patient Global Impression of Severity
P-gp
P-glycoprotein
PK
pharmacokinetics
PP
per protocol
PR
partial remission
PRO
patient-reported outcome
PS
patient safety
PT
prothrombin time
R/R
relapsed/refractory
RBC
red blood cell
Rh
Rhesus factor
RNA
ribonucleic acid
RO
receptor occupancy
SAE
serious adverse event
SAP
statistical analysis plan
SC
subcutaneously
SCT
stem cell transplant
SD
stable disease
SDV
source data verification
SGOT
serum glutamic oxaloacetic transaminase
SGPT
serum glutamic pyruvic transaminase


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SIRPα
signal regulatory protein alpha
SOC
standard of care
SOP
standard operating procedure
SSR
special situation report
SUSAR
suspected unexpected serious adverse reaction
TLS
tumor lysis syndrome
TTD
time to first deterioration
ULN
upper limit of normal
US
United States
VEN
venetoclax
w/v
weight-to-volume ratio
WBC
white blood cell
WHO
World Health Organization


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1.
INTRODUCTION
1.1.
Background
1.1.1.
Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is an aggressive clonal hematopoietic malignancy of myeloid 
cells in the blood and bone marrow leading to cytopenias and ultimately mortality via sequelae 
of bone marrow failure. The incidence of AML rises from 3 cases per 100,000 people in young 
adults to greater than 20 cases per 100,000 people in older adults. Initial treatment for AML is 
dependent on age and comorbidities. For patients < 60 years of age, 5-year overall survival (OS) 
is approximately 40% to 50% but is only 5% for patients > 60 years of age. For younger patients 
who are fit for intensive chemotherapy, induction chemotherapy with cytarabine and an 
anthracycline chemotherapy is the standard of care (SOC). In patients who are older and/or have 
comorbidities that preclude the use of induction chemotherapy, lower-intensity therapy is given 
with hypomethylating agents (HMAs) and low-dose cytarabine, with or without venetoclax, a 
Bcl-2 inhibitor. In all settings of AML, disease relapse is common despite an initial therapeutic 
response and is the most common reason for death.
1.1.2.
Patients Newly Diagnosed with AML Who Are Ineligible for Intensive 
Induction Chemotherapy
Patients who are older (approximately 75 years of age and older) or who have comorbidities 
precluding the use of intensive induction chemotherapy are treated with HMAs (ie, azacitidine or 
decitabine), low-dose cytarabine, and these agents in combination with venetoclax. In 2018, 
venetoclax in combination with HMAs or low-dose cytarabine was granted accelerated approval 
in the United States (US) for this population. This approval was based on results from multiple 
single-arm studies in which venetoclax demonstrated a complete remission (CR) rate of 37% in 
combination with azacitidine, 54% in combination with decitabine, and 21% in combination with 
low-dose cytarabine {VENCLEXTA 2020}. The median duration of CR was approximately 
4.8 to 6.0 months. Final results from a subsequent randomized Phase 3 trial that evaluated 
venetoclax + azacitidine versus azacitidine monotherapy in the same patient population 
demonstrated a significant benefit in median OS compared with the control arm (14.7 vs 
9.6 months, hazard ratio [HR] 0.66) {DiNardo 2020}. In addition, the CR/complete remission 
with incomplete hematologic recovery (CRi) rate was higher in the venetoclax + azacitidine arm 
than the azacitidine control arm (66.4% vs. 28.3%). These data have supported the use of 
venetoclax in combination with HMAs as the SOC for newly diagnosed patients with AML who 
are ineligible for intensive chemotherapy.
1.2.
Magrolimab
1.2.1.
General Information
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 


Magrolimab
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“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}.
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 
crystallizable fragment (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 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).
Magrolimab is being investigated as an anti-cancer therapeutic in several global ongoing clinical 
studies, as monotherapy or in combination with other therapeutics, for the treatment of NHL, 
AML, MDS, and several solid tumor types.


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While magrolimab has single-agent preclinical and clinical activity, efficacy is best enhanced in 
combination with other anti-cancer agents. Preclinical and clinical studies have shown that 
magrolimab combinations with cytotoxic agents can enhance prophagocytic signals on tumor 
cells, which can lead to synergistic phagocytosis of cancer cells by macrophages. As such, 
magrolimab is being evaluated clinically in several combinations with cytotoxic agents including 
chemotherapy.
For further information on magrolimab, refer to the current investigator’s brochure (IB).
1.2.2.
Preclinical 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 antiphagocytic 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 with 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 are provided in the current IB.
1.2.3.
Clinical Studies of 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 a Phase 1 study (SCI-CD47-001) 
in patients with solid tumors. In this study, patients were treated with weekly magrolimab doses 
ranging 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 a Phase 1 AML study (SCI-CD47-002), similarly 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).
Preliminary PK data of magrolimab from other ongoing studies (5F9003, 5F9004, 5F9005, and 
5F9006) indicate similar PK properties across all tumor populations and in the presence of 
co-administered drugs. Across all studies, 34 of 507 (6.7%) 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.


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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 being studied in several 
clinical studies in MDS, AML, and solid tumors.
Magrolimab has been evaluated as a monotherapy or in combination in multiple solid tumor 
types. In the Phase 1 study SCI-CD47-001 of magrolimab monotherapy, 88 patients with 
advanced solid tumors were treated with magrolimab doses up to 45 mg/kg. No maximum 
tolerated dose (MTD) was reached. Across 548 patients treated with magrolimab, including 
patients with both solid tumors and hematologic malignancies, fatigue, anemia, and headache 
were the 3 most frequently reported AEs (43.0%, 40.8%, and 36.4% of patients, respectively). 
Patients experienced mostly Grade 1 and 2 fatigue (2.8% of patients reported severe fatigue).
Anemia is the most common treatment-related AE, reported in 35.4% of patients. Approximately 
13% of all patients experienced anemia Grade 1 or 2, and 22% experienced severe anemia. 
Notably, many events of severe anemia occurred in patients with AML and MDS who had severe 
anemia at baseline. Anemia was typically manifested as a decline in hemoglobin observed within 
the first 2 weeks of treatment. The initial decrease in hemoglobin after the first dose averages 
0.4 to 1.5 g/dL, with hemoglobin improving in many patients on therapy back to baseline, with a 
decrease in red blood cell (RBC) transfusion requirements for those patients who were 
transfusion-dependent at baseline. In patients with solid tumors, the decrease in hemoglobin was 
followed by a compensatory reticulocytosis, with many patients experiencing a gradual return to 
baseline despite continued dosing. The changes in hemoglobin and reticulocytes described with 
magrolimab treatment are fairly consistent across tumor types and are shown in Figure 1. 
Hyperbilirubinemia (predominately unconjugated) indicates extravascular hemolysis consistent 
with phagocytic removal of RBCs arising from the blockade of CD47 signaling. Administration 
of a low priming dose of magrolimab mitigated on-target anemia, an effect that is mostly 
observed after the first dose.


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Figure 1.
Effect of Magrolimab on Anemia, and Mitigation with a 
Priming/Maintenance Dosing Regimen
5F9 = magrolimab
The red blood cell profile of a solid tumor patient treated with magrolimab monotherapy is shown {Sikic 2019}.
Infusion-related reactions (IRRs) are also a commonly reported AE with magrolimab. Of 
548 patients across 5 studies, 29% had at least 1 IRR. Most common signs and symptoms of IRR 
related to magrolimab included chills, pyrexia, back pain, headache, nausea, vomiting, dyspnea, 
anemia, and blood bilirubin increase. These IRRs were generally observed during the initial 
2 doses of magrolimab. Current recommendations for premedication and IRR management are 
described in Sections 5.5.3 and 5.5.4.
Lastly, hemagglutination (RBC agglutination) as observed on the peripheral smear is a common 
treatment effect and was reported as a treatment-related AE in 11.8% of all patients. Transient 
hemagglutination is observed after the initial priming or first maintenance dose of drug; 
however, it is less common thereafter, and has not been consistently correlated with any clinical 
sequelae.
As of December 2020, 52 untreated induction chemotherapy-ineligible AML patients have been 
enrolled in Study 5F9005 and received the combination of magrolimab + azacytidine {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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The most common treatment-emergent adverse events (TEAE) reported in > 10% of frontline 
AML patients treated with magrolimab and azacitidine are presented in Table 1 (data on file). 
The most common TEAEs reported in > 10% of AML patients with the TP53 mutation are 
presented in Table 2 (data on file) and are similar to those reported in all AML patients.
Additional patients continue to be enrolled on the Phase 1b study. In addition, a randomized 
Phase 3 study (GS-US-546-5857) of magrolimab in combination with azacitidine versus 
venetoclax plus azacitidine in previously untreated patients with AML with the TP53 mutation 
who are ineligible for intensive induction chemotherapy is planned to initiate in 2021.
Table 1.
Study 5F9005: Treatment Emergent Adverse Events Reported in 
> 10% of Subjects with First-Line Unfit AML (biomarker unselected) 
Treated with Magrolimab and Azacitidine by Preferred Term
Preferred Term
All Grades
n (%)
N = 64
Nausea
29 (45.3)
Febrile neutropenia
28 (43.8)
Constipation
27 (42.2)
Diarrhoea
24 (37.5)
Fatigue
23 (35.9)
Decreased appetite
22 (34.4)
Anaemia
20 (31.3)
Dizziness
18 (28.1)
Abdominal pain
17 (26.6)
Platelet count decreased
17 (26.6)
Pyrexia
17 (26.6)
Fall
16 (25.0)
Oedema peripheral
16 (25)
Blood bilirubin increased
15 (23.4)
Hypokalaemia
15 (23.4)
Chills
14 (21.9)
Cough
14 (21.9)
Dyspnoea
14 (21.9)
Hypophosphataemia
14 (21.9)
Confusional state
13 (20.3)
Epistaxis
13 (20.3)


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Preferred Term
All Grades
n (%)
N = 64
Vomiting
13 (20.3)
Alanine aminotransferase increased
12 (18.8)
Hypotension
12 (18.8)
Pneumonia
12 (18.8)
White blood cell count decreased
12 (18.8)
Arthralgia
10 (15.6)
Insomnia
10 (15.6)
Aspartate aminotransferase increased
9 (14.1)
Headache
9 (14.1)
Neutropenia
9 (14.1)
Neutrophil count decreased
9 (14.1)
Thrombocytopenia
9 (14.1)
Anxiety
8 (12.5)
Asthenia
8 (12.5)
Hyponatraemia
8 (12.5)
Muscular weakness
8 (12.5)
Weight decreased
8 (12.5)
Contusion
7 (10.9)
Dyspepsia
7 (10.9)
Hypomagnesaemia
7 (10.9)
Hypoxia
7 (10.9)
Pleural effusion
7 (10.9)
Rash maculo-papular
7 (10.9)
AE = adverse event; AML = acute myeloid leukemia
Treatment emergent AEs are defined as AEs with onset date between the first treatment date and 30 days after the last treatment 
date.
AEs are coded according to MedDRA v23.1.
Data extracted 04 November 2020


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Table 2.
Study 5F9005: Treatment Emergent Adverse Events Reported in 
> 10% of Subjects with First-Line TP53-Mutated Unfit AML Treated 
with Magrolimab and Azacitidine by Preferred Term
Preferred Term
All Grades
n (%)
N = 47
Febrile neutropenia
24 (51.1)
Constipation
20 (42.6)
Diarrhoea
18 (38.3)
Nausea
18 (38.3)
Decreased appetite
17 (36.2)
Fatigue
17 (36.2)
Abdominal pain
14 (29.8)
Anaemia
14 (29.8)
Dizziness
14 (29.8)
Oedema peripheral
13 (27.7)
Blood bilirubin increased
12 (25.5)
Cough
12 (25.5)
Hypophosphataemia
12 (25.5)
Fall
11 (23.4)
Hypokalaemia
11 (23.4)
Infusion-related reaction
11 (23.4)
Platelet count decreased
11 (23.4)
Vomiting
11 (23.4)
Chills
10 (21.3)
Hypotension
10 (21.3)
Pneumonia
10 (21.3)
Epistaxis
9 (19.1)
Pyrexia
9 (19.1)
White blood cell count decreased
9 (19.1)
Alanine aminotransferase increased
8 (17.0)
Headache
8 (17.0)
Aspartate aminotransferase increased
7 (14.9)
Confusional state
7 (14.9)
Pleural effusion
7 (14.9)


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Preferred Term
All Grades
n (%)
N = 47
Anxiety
6 (12.8)
Arthralgia
6 (12.8)
Contusion
6 (12.8)
Dyspnoea
6 (12.8)
Hypomagnesaemia
6 (12.8)
Hyponatraemia
6 (12.8)
Muscular weakness
6 (12.8)
Weight decreased
6 (12.8)
Acute kidney injury
5 (10.6)
Hypoxia
5 (10.6)
Injection site reaction
5 (10.6)
Neutrophil count decreased
5 (10.6)
Pruritis
5 (10.6)
Sinus Tachycardia
5 (10.6)
Thrombocytopenia
5 (10.6)
Urinary incontinence
5 (10.6)
AE = adverse event; AML = acute myeloid leukemia
Treatment emergent AEs are defined as AEs with onset date between the first treatment date and 30 days after the last treatment 
date.
AEs are coded according to MedDRA v23.1.
Data extracted 04 November 2020
1.2.3.3.
Summary of Clinical Safety and Efficacy of Magrolimab + Venetoclax + 
Azacitidine in AML
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. 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 {Sallman 2020b}. The 


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efficacy of magrolimab + azacitidine appears improved compared to azacitidine monotherapy 
based on data from historical trials, in which CR rates are between 10% and 20%. High rates of 
MRD negativity and prolonged OS are encouraging.
An investigator-initiated study (IIS) sponsored by the MD Anderson Cancer Center (protocol ID 
2020-0027) commenced in the second half of 2020 to evaluate the safety, tolerability, 
recommended Phase 2 dose, and preliminary efficacy of magrolimab in combination with 
azacitidine and venetoclax in patients with relapsed/refractory (R/R) AML and patients with 
newly diagnosed AML who are ineligible for intensive chemotherapy or with poor-risk 
karyotype or molecular markers. In the 6 patients with R/R AML enrolled in the safety run-in 
cohort, no dose-limiting toxicity (DLT) was reported. None of the 19 patients with AML 
(9 frontline and 10 R/R) enrolled before 01 March 2021 died within 60 days of receiving their 
first dose of study drugs. Of the 9 newly diagnosed patients with AML considered ineligible for 
intensive therapy due to age/comorbidities/poor-risk karyotype or molecular markers, the ORR 
was 88.9 % (CR of 66.7% and CRi of 22.2%). Out of these 9 first-line AML patients, 5 harbored 
TP53 mutations and ORR in this population was 80 % (CR and CRi of 40% respectively).
Adverse events reported in more than 2 patients in the IIS are presented in Table 3 (data on file). 
Adverse events reported in more than 2 patients in the IIS with the TP53 mutation are presented 
in Table 4 (data on file) and are similar to those reported in all AML patients.
Overall, these preliminary data suggest that the combination of magrolimab with azacitidine and 
venetoclax has an acceptable safety profile and encouraging clinical efficacy in limited follow up 
in frontline AML ineligible for intensive chemotherapy (Unpublished data, 
 
Anderson Cancer Center, MDACC).
Table 3.
2020-0027: MDACC Investigator Initiated Study: Adverse Events 
Reported in ≥ 2 Subjects with AML Treated with 
Magrolimab + Venetoclax + Azacitidine by Preferred Term
Preferred Term
All Grades
n (%)
N = 19
Blood bilirubin increased
11 (57.9)
Dizziness
11 (57.9)
Hypophosphatemia
11 (57.9)
Fever
10 (52.6)
Hypokalemia
10 (52.6)
Anorexia
9 (47.4)
Fatigue
9 (47.4)
Hyponatremia
9 (47.4)
Insomnia
9 (47.4)
Nausea
9 (47.4)
PPD


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Preferred Term
All Grades
n (%)
N = 19
Sinus tachycardia
9 (47.4)
Constipation
8 (42.1)
Cough
8 (42.1)
Dyspnea
8 (42.1)
Edema limbs
8 (42.1)
Bruising
7 (36.8)
Diarrhea
7 (36.8)
Febrile neutropenia
7 (36.8)
Hypotension
7 (36.8)
Alanine aminotransferase increased
6 (31.6)
Alkaline phosphatase increased
6 (31.6)
Epistaxis
6 (31.6)
Generalized muscle weakness
6 (31.6)
Headache
6 (31.6)
Hypoalbuminemia
6 (31.6)
Infections
6 (31.6)
Lung infection
6 (31.6)
Abdominal pain
5 (26.3)
Back pain
5 (26.3)
Chills
5 (26.3)
Hypocalcemia
5 (26.3)
Hypomagnesemia
5 (26.3)
Mucositis oral
5 (26.3)
Paresthesia
5 (26.3)
Pruritus
5 (26.3)
Vomiting
5 (26.3)
Arthralgia
4 (21.1)
Gait disturbance
4 (21.1)
Hyperglycemia
4 (21.1)
Pain
4 (21.1)
Sepsis
4 (21.1)
Anxiety
3 (15.8)


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Preferred Term
All Grades
n (%)
N = 19
Creatinine increased
3 (15.8)
Dental cariesa
3 (15.8)
Ear pain
3 (15.8)
Erythema multiforme
3 (15.8)
Fall
3 (15.8)
Hematuria
3 (15.8)
Infusion-related reaction
3 (15.8)
Pain in extremity
3 (15.8)
Peripheral motor neuropathy
3 (15.8)
Rectal pain
3 (15.8)
Skin infection
3 (15.8)
Sore throat
3 (15.8)
Anemia
2 (10.5)
Bacteremia
2 (10.5)
Blurred vision
2 (10.5)
Flank pain
2 (10.5)
Myalgia
2 (10.5)
Papulopustular rash
2 (10.5)
Platelet count decreased
2 (10.5)
Pleural effusion
2 (10.5)
Rash pustular
2 (10.5)
Respiratory failure
2 (10.5)
Somnolence
2 (10.5)
Spinal cord compression
2 (10.5)
Thrush
2 (10.5)
Deep vein thrombosis
2 (10.5)
AML = acute myeloid leukemia; MDACC = MD Anderson Cancer Center
a
Not coded by MedDRA
Multiple events were counted only once per subject.
Data extracted 20 April 2021


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Table 4.
2020-0027: MDACC Investigator Initiated Study: Adverse Events 
Reported in ≥ 2 Subjects with TP53 mutated AML Treated with 
Magrolimab + Venetoclax + Azacitidine by Preferred Term
Preferred Term
All Grades
n (%)
N = 11
Dizziness
8 (72.7)
Hypophosphatemia
7 (63.6)
Constipation
6 (54.5)
Hypokalemia
6 (54.5)
Insomnia
6 (54.5)
Sinus tachycardia
6 (54.5)
Blood bilirubin increased
5 (45.5)
Cough
5 (45.5)
Dyspnea
5 (45.5)
Edema limbs
5 (45.5)
Fatigue
5 (45.5)
Fever
5 (45.5)
Generalized muscle weakness
5 (45.5)
Hyponatremia
5 (45.5)
Hypotension
5 (45.5)
Anorexia
4 (36.4)
Bruising
4 (36.4)
Diarrhea
4 (36.4)
Epistaxis
4 (36.4)
Febrile neutropenia
4 (36.4)
Hypoalbuminemia
4 (36.4)
Hypokalemia
4 (36.4)
Hypomagnesemia
4 (36.4)
Infection
4 (36.4)
Mucositis oral
4 (36.4)
Nausea
4 (36.4)
Alanine aminotransferase increased
3 (27.3)
Anxiety
3 (27.3)
Back pain
3 (27.3)


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Preferred Term
All Grades
n (%)
N = 11
Chills 
3 (27.3)
Fall
3 (27.3)
Gait disturbance
3 (27.3)
Headache
3 (27.3)
Lung infection
3 (27.3)
Peripheral motor neuropathy
3 (27.3)
Pruritus
3 (27.3)
Sepsis
3 (27.3)
Vomiting
3 (27.3)
Abdominal pain
2 (18.2)
Alkaline phosphatase increased
2 (18.2)
Anemia
2 (18.2)
Arthralgia
2 (18.2)
Blurred vision
2 (18.2)
Creatinine increased
2 (18.2)
Dental caries
2 (18.2)
Ear pain
2 (18.2)
Erythema multiforme
2 (18.2)
Hematuria
2 (18.2)
Hyperglycemia
2 (18.2)
Pain in extremity
2 (18.2)
Paresthesia
2 (18.2)
Rectal pain
2 (18.2)
Skin infection
2 (18.2)
Spinal cord compression
2 (10.5)
AML = acute myeloid leukemia; MDACC = MD Anderson Cancer Center
Data extracted 20 April 2021
For further clinical efficacy and safety information of magrolimab in other indications, refer to 
the current magrolimab IB.


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1.3.
Information About Venetoclax, 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 < 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 pro-apoptotic proteins such as bcl-2–interacting mediator of cell death, 
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 in combination with azacitidine, decitabine, or low-dose cytarabine is 
approved for the treatment of newly diagnosed AML in adults who are ≥ 75 years of age, or who 
have comorbidities that preclude use of intensive induction chemotherapy {VENCLEXTA 
2020}.
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, refer to the prescribing information.


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1.3.3.
Clinical Data for Venetoclax + Azacitidine
Venetoclax in combination with azacitidine or decitabine was studied in M14-358, a 
non-randomized, open-label clinical study involving patients with newly diagnosed AML 
{VENCLEXTA 2020}. Sixty-seven of the 84 patients who received venetoclax with azacitidine 
were ≥ 75 years of age or had comorbidities that precluded the use of intensive induction 
chemotherapy. Patients received venetoclax after a 5-week ramp-up to a final 400-mg once-daily 
oral dose and azacitidine at the standard dosing. The median follow-up was 15.9 months (range: 
0.4 to 40.3 months). Forty-three percent (29 of 67 patients) achieved a CR (95% CI: 31%, 56%) 
and 18% (12 of 67 patients) achieved a CR with partial hematologic recovery (CRh) (95% CI: 
9.6%, 29%). Median time to first CR or CRh was 1.0 month (range: 0.7 to 8.9 months). The 
median duration of CR was 23.8 months (95% CI: 15.4, –) and the median duration of CR or 
CRh was 26.5 months (95% CI: 17.4, –). Of patients treated with venetoclax in combination with 
azacitidine, 12% (8 of 67) subsequently received SCT. Seventeen of the 84 patients who received 
venetoclax with azacitidine were 65 to 74 years of age and did not have known comorbidities 
that precluded the use of intensive induction chemotherapy. 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%). Nine patients (53%) subsequently received SCT. The 
most common AEs of any grade observed with patients treated with venetoclax and azacitidine 
or venetoclax and decitabine were febrile neutropenia (69%), fatigue (62%), constipation (62%), 
musculoskeletal pain (54%), dizziness (54%), nausea (54%), abdominal pain (46%), diarrhea 
(46%), pneumonia (46%), sepsis (excluding fungal; 46%), cough (38%), pyrexia (31%), 
hypotension (31%), oropharyngeal pain (31%), edema (31%), and vomiting (31%).
The Phase 3 randomized, double-blind, placebo-controlled study VIALE-A, investigating 
venetoclax in combination with azacitidine versus azacitidine in combination with placebo in 
treatment-naive AML patients who are ineligible for intensive chemotherapy, confirms the 
efficacy of venetoclax + azacitidine with a statistically significant improvement in OS. Median 
OS with venetoclax + azacitidine was 14.7 months, while the median OS with 
azacitidine + placebo was 9.6 months (HR 0.66 [95% CI: 0.52, 0.85]; p < .001) {DiNardo 2020}. 
Safety of the combination in VIALE-A was similar to what had been previously reported and can 
be managed with standard supportive care.
1.3.4.
 Information About Auxiliary Medicinal Products/Noninvestigational 
Products
Acetaminophen (also known as paracetamol), diphenhydramine, and corticosteroids 
(dexamethasone) are considered auxiliary medicinal products (AxMPs) for this clinical study 
(Appendix 14). Acetaminophen is approved for pain relief and fever reduction. 
Diphenhydramine is an antihistamine and is used for amelioration of allergic reactions. 
Corticosteroids are anti-inflammatory medications and are used for the amelioration of allergic 
reactions. The use of these medications on this study is described in Section 5.5.4. 
Additional details on acetaminophen, diphenhydramine, and corticosteroids can be found in the 
prescribing information.


Magrolimab
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1.4.
Rationale for This Study
Magrolimab is under clinical evaluation in combination with azacitidine in the ongoing Phase 1b 
study, 5F9005, in patients with AML who are previously untreated and ineligible for intensive 
induction chemotherapy. Among 34 evaluable patients, 65% achieved an OR and 44% achieved 
a CR. Time to response was rapid (median 2.04 months) {Sallman 2020a}. Clinical activity has 
also been observed in patients with the TP53 mutation, a poor-risk subgroup with an overall 
response rate of 71%. Median OS was 12.9 months in patients with the TP53 mutation and 
18.9 months in patients with wild-type TP53. Given the encouraging efficacy data observed with 
the magrolimab plus azacitidine and venetoclax plus azacitidine double combinations, the triple 
combination of magrolimab plus azacitidine plus venetoclax is anticipated to show superior 
activity over either double combination. In terms of safety, the addition of magrolimab to 
venetoclax and azacitidine is not anticipated to have overlapping toxicities, as magrolimab 
monotherapy does not cause myelosuppression, which is a key toxicity of venetoclax and 
azacitidine. These hypotheses are supported by preliminary data from the MD Anderson Cancer 
Center IIS that have shown no DLT, no deaths within 60 days of the first dose of study drugs, 
and signs of encouraging early efficacy in patients treated with the combination of magrolimab 
with azacitidine and venetoclax in frontline AML. Emerging data from this study have informed 
design elements for the current study.
Furthermore, nonclinical data demonstrate that venetoclax can enhance magrolimab-mediated 
phagocytosis, which can be further enhanced by azacitidine (Figure 2).


Magrolimab 
Protocol GS-US-590-6154 
Final 
Gilead Sciences, Inc. 
Amendment 7 
Figure 2. 
In Vitro Phagocytosis of AML Cells with Magrolimab, Azacitidine 
and/or Venetoclax 
3 
g> 2 
+I 
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~ 
AML = acute myeloid leukemia; Rx = treatment 
• 
p<0.0001 
p=0.003 I 
p,i-ooos I 
• 
• 
Human macrophages were incubated with AML HL60 cells in the presence of the indicated therapeutic agents with macrophage 
phagocytosis of AML cells measured. 
Additional nonclinical study in vitro suggests that in a variety of AML-derived cell lines, 
including sub-lines with intrinsic resistance to venetoclax + azacitidine-induced cytotoxicity, 
these agents can nonetheless increase phagocytosis by macrophages, likely due to upregulation 
of prophagocytic signals on the cell surface. Fmi he1more, co-treatment with magrolimab can 
fmiher increase phagocytosis in combination with venetoclax and azacitidine (Figure 3). 
CONFIDENTIAL 
Page 41 
15 December 2023 


Magrolimab
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Final
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Figure 3.
Magrolimab-Induced In Vitro Phagocytosis of AML Cells Resistant to 
Venetoclax and Azacitidine Cytotoxicity
5F9 = magrolimab; AZA = azacitidine; DMSO = vehicle control; Macro = macrophage; VEN = venetoclax
Human macrophages were incubated with either MOLM-13 AML cells, or VEN + AZA resistant sub-lines in the presence of the 
indicated therapeutic agents. Phagocytosis indicated on y axis was quantified by flow cytometry.
Unpublished data, Marina Konopleva Lab, MD Anderson Cancer Center
Magrolimab, venetoclax, and azacitidine have been tested in combination in an in vivo model of 
primary human AML engrafted into immunocompromised mice. Following engraftment and 
detectable disease burden in the peripheral blood, mice were treated with vehicle control, a 
combination of venetoclax and azacitidine, magrolimab (5F9), or a combination of magrolimab, 
venetoclax, and azacitidine. In this model, venetoclax plus azacitidine has no efficacy; in 
contrast, magrolimab monotherapy significantly extends survival. The combination of 
magrolimab plus venetoclax plus azacitidine shows synergistic efficacy, extending mouse 
survival to a greater degree than the other therapeutic regimens tested (Figure 4).
MOLM-13 
MOLM-13 
Parental 
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Magrolimab
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Final
Gilead Sciences, Inc.
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Figure 4.
Magrolimab Synergistically Increases the Efficacy of Venetoclax Plus 
Azacitidine in a Patient-Derived Xenograft Model
5F9 = magrolimab; AZA = azacitidine; PDX 3871344 = patient-derived xenograft, VEN + AZA resistant primary AML; 
VEN = venetoclax
Primary patient AML cells were injected into immunocompromised NSG mice and allowed to engraft until peripheral disease 
burden was detected. Treatment of the indicated compounds was administered from day 83 to day 106 post engraftment, and 
mice were followed for survival.
Unpublished data, Marina Konopleva Lab, MD Anderson Cancer Center
In summary, the nonclinical rationale and clinical data support the evaluation of magrolimab in 
combination with azacitidine and venetoclax in frontline AML patients who are ineligible for 
intensive chemotherapy.
1.5.
Rationale for Dose Selection of Magrolimab
The rationale for the magrolimab dose proposed in this study originates from safety, efficacy, 
and PK/pharmacodynamics (PD) 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 weekly dose of 
45 mg/kg has an acceptable safety profile, and no MTD was identified in this study.
PDX 3871344 
100 
_._ Vehicle 
iij 
--'- VEN+AZA 
> 
-~ 
_._ 5F9 
::::s 
1/1 
_._ VEN+AZA+5F9 
-
50 
C: 
CII 
0 ... 
CII 
a. 
0 
0 
100 
200 
300 
400 
Days 


Magrolimab 
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Amendment 7 
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 DLT was 
observed, and magrolimab had an acceptable safety profile over the tested dose range up to a 
maximum of 30 mg/kg twice weekly. Fmthe1more, in these 2 studies, an intrapatient dose 
escalation approach was followed; after the priming dose, the patients received a dose of 
15 mg/kg on Day 8 during Week 2, after which the dose was escalated to 30 mg/kg on Day 11 
and weekly thereafter through the end of Cycle 1, and eve1y 2 weeks from Cycle 2 and onward. 
This schedule was based on nonclinical data indicating enhanced safety of intrapatient dose 
escalation. The MD Anderson Cancer Center IIS evaluating the combination of magrolimab with 
venetoclax and azacitidine used the same dosing schedule for magrolimab, with venetoclax and 
azacitidine dosed per their USPI, and no DLT was observed during the safety nm-in. 
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 eve1y week 
followed by eve1y 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 
proposed study population, both as a monotherapy and in combination with other tumor-targeted 
antibodies and chemotherapeutics. 
In Study SCI-CD47-002 and Study 5F9005, CD47 RO by magrolimab was tested at baseline and 
at multiple time points on treatment, on both peripheral blood and bone manow cells, including 
leukeinic blasts. A PK/PD 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 maiTow cells at the magrolimab dosing regimens proposed in this 
study. This level of RO is typically associated with maximal efficacy for all immune-oncology 
f b d' 
Th 
fi 
th 
d d 
• 
t d t 
ffi 
• th 
• • 
• 
• 
• 
• • 
Based on results from the Phase 1 b study of magrolimab in MDS and AML (Study 5F9005) and 
the MD Anderson Cancer Center IIS, the cmTent study is designed to employ the same 
intrapatient dose escalation regimen for magrolimab to mitigate on-target toxicities such as 
anemia and other toxicities observed in nonclinical AML models. Treatment should be continued 
until disease progression, relapse, loss of clinical benefit, or unacceptable toxicity occur, or other 
study discontinuation criteria are met. Clinical benefit, as dete1mined by the investigator, can 
include transfusion independence, adequate blood counts, symptomatic improvement, or other 
criteria as dete1mined by the investigator. 
In smnmaiy, the proposed dose regimens have been shown to have acceptable safety profiles in 
oncology patient populations. Based on PK/PD modeling, the proposed doses are predicted to 
result in optimal efficacy in myeloid malignancy populations and maximize patient and caregiver 
convemence. 
CONFIDENTIAL 
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15 December 2023 


Magrolimab
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1.6.
Risk/Benefit Assessment for the Study
Nonclinical data demonstrate enhanced efficacy when magrolimab is combined with venetoclax 
and azacitidine. Furthermore, encouraging clinical activity has been observed with both 
magrolimab plus azacitidine and venetoclax plus azacitidine double combinations, and supports 
the concept that a triple combination may lead to improved efficacy. Preliminary data from the 
MD Anderson Cancer Center IIS suggest encouraging clinical efficacy in frontline AML in 
patients ineligible for intensive chemotherapy.
Venetoclax and azacitidine have overlapping toxicities, particularly myelosuppression and 
infections. Anemia, neutropenia, thrombocytopenia, and infections have been reported in patients 
treated with magrolimab. 
Specific safety assessments to monitor for expected toxicities to each of these agents will be 
implemented. These include monitoring for myelosuppression, tumor lysis syndrome (TLS), 
hepatotoxicity, IRRs, and other expected toxicities. Detailed guidance on dose modification/dose 
holds for each study drug, depending on the type of toxicity, is provided in Section 5.5.
An infectious disease pandemic may pose additional risks to study drug availability, study visit 
schedule, and adherence to protocol-specified safety monitoring or laboratory assessments. Refer 
to Appendix 2 for further details on the risks and risk mitigation strategy. Given the risk 
mitigation measures that are being implemented, the expected benefit-risk assessment to patients 
remains unchanged.
In summary, based on strong scientific rationale, nonclinical and emerging clinical efficacy data, 
and the manageable safety profile with the proposed magrolimab combination regimens, this 
study has an acceptable risk/benefit ratio for patients who participate.
1.7.
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 endpoints of this study are described in Table 5.
Table 5.
Study Objectives and Endpoints
Objective
Endpoint
Primary:
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine in patients with 
previously untreated AML who are ineligible for 
intensive chemotherapy as measured by overall 
survival (OS)
•
OS, 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 + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by the rate of 
complete remission (CR) + complete remission 
with partial hematologic recovery (CRh) within 6 
cycles of treatment
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by the rate of 
CR within 6 cycles of treatment
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by event-free 
survival (EFS)
•
To evaluate the duration of CR + CRh in patients 
who achieved CR or CRh within 6 cycles of 
treatment
•
To evaluate the duration of complete remission 
(DCR) in patients who achieved CR within 
6 cycles of treatment 
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by rate of 
CR + CRh without minimal residual disease 
(MRD-) within 6 cycles of treatment
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by rate of 
CR without minimal residual disease (CRMRD-) 
within 6 cycles of treatment
•
Rate of CR + CRh within 6 cycles of treatment
•
Rate of CR within 6 cycles of treatment
•
EFS
•
Duration of CR + CRh in patients who achieved 
CR or CRh within 6 cycles of treatment
•
DCR in patients who achieved CR within 6 cycles 
of treatment
•
Rate of CR/CRhMRD- within 6 cycles of treatment
•
Rate of CRMRD- within 6 cycles of treatment
•
Transfusion independence conversion rate
•
TTD on the GHS/QoL and the physical 
functioning scales of the EORTC QLQ-C30
•
Incidence of treatment-emergent adverse events 
(AEs) and clinical laboratory abnormalities during 
the study 
•
Magrolimab serum concentrations over time
•
Incidence/prevalence rate and magnitude of anti-
magrolimab antibodies in serum


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Objective
Endpoint
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by 
conversion rate of transfusion dependence to 
transfusion independence
•
To compare the efficacy of magrolimab + 
venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine as measured by time to 
first deterioration (TTD) on the global health 
status/quality of life (GHS/QoL) and the physical 
functioning scales of the European Organisation 
for Research and Treatment of Cancer Quality of 
Life Questionnaire (EORTC QLQ-C30)
•
To assess the safety and tolerability of magrolimab 
+ venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine
•
To evaluate the PK and immunogenicity of 
magrolimab
CCI


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Objective
Endpoint
•
To evaluate the duration of response (DOR) and 
the duration of CR + CRi achieved within 6 cycles 
of treatment 
•
To evaluate minimal residual disease (MRD) 
negativity in patients with CR + CRh
•
To evaluate minimal residual disease (MRD) 
negativity in patients with CR + CRi
•
To evaluate minimal MRD negativity by flow 
cytometry and next generation sequencing (NGS)
•
To compare the rate of SCT between magrolimab 
+ venetoclax + azacitidine versus placebo + 
venetoclax + azacitidine
•
To evaluate 30- and 60-day mortality in patients 
treated with magrolimab + venetoclax + 
azacitidine versus placebo + venetoclax + 
azacitidine
•
To assess biomarkers of immune cell recruitment 
and immune cell signaling 
•
To assess the mechanism of intrinsic and acquired 
resistance to magrolimab + venetoclax + 
azacitidine
•
Changes and percentage changes from baseline of 
biomarkers including biomarkers of immune cell 
recruitment or of immune cell signaling
•
Biomarkers related to resistance, including 
mutational profile of leukemic clones, and 
immune profile of tumor microenvironment


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3.
STUDY DESIGN
3.1.
Study Design
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing 
magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in newly 
diagnosed, previously untreated patients with AML who are ineligible for intensive 
chemotherapy.
Approximately 432 patients will be randomized in 1:1 ratio to receive either magrolimab + 
venetoclax + azacitidine (experimental arm) or placebo + venetoclax + azacitidine (control arm). 
Randomization will be stratified by 3 factors:
•
age (< 75 years, ≥ 75 years)
•
genetic risk group (favorable/intermediate, adverse, unknown) (Appendix 8)
•
geographic region (United States [US], outside the US)
The study schematic is presented in Figure 5.
Figure 5.
Study Schema
3.2.
Study Treatments
Study treatments are presented in Table 6, and the schedule of treatment administration is 
provided in Appendix Table 2 and Appendix Table 3.
Newly diagnosed, 
previously untreated AM L 
patients who are ineligible 
for intensive chemotherapy 
(based on object ive 
criteria) 
Primary Endpoint: 
Overall Survival 
-----
1:1 randomization 
--------
N=216 
Placebo+ venetoclax + azacitidine 
N=216 
Stratifications: 
1. 
2. 
3. 
Age (<75 years, 2: 75 years) 
Genetic risk group (favorable/ 
intermediate, adverse, unknown) 
Geographic region (US, outside t he 
US) 


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Table 6.
Study Treatments
Dose Schedule 
(Day per 28-day Cycle)
Treatment 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
Azacitidine
75 mg/m2 SC or IVa
Days 1-7
or
Days 1-5 and 8-9
Days 1-7
or
Days 1-5 and 8-9
Days 1-7
or
Days 1-5 and 8-9
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  5 doses 
Experimental arm 
(magrolimab + venetoclax 
+ azacitidine)
Magrolimab 30 mg/kg IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly 30 mg/kg 
dose
Venetoclax 100 mg oral
Day 1
— 
— 
Venetoclax 200 mg oral
Day 2
—
—
Venetoclax 400 mg oral
Day 3 and daily 
thereafter 
Daily
Daily
Azacitidine 
75 mg/m2 SC or IVa
Days 1-7
or
Days 1–5 and 8-9
Days 1-7
or
Days 1-5 and 8-9
Days 1–7
or
Days 1-5 and 8-9
Placebo Administration
Placebo IV
(over 3 hours)
Days 1, 4
Placebo IV
(over 3 hours)
Day 8
Placebo IV
(over 2 hours)
Days 11 and 15, and then QW  5 doses 
Control arm (placebo + 
venetoclax + azacitidine)
Placebo IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly dose
IV = intravenous; QW = every week; Q2W = every 2 weeks; SC = subcutaneous
a
Azacitidine administered per region-specific labeling or within Days 1-9 of a 28-day cycle per protocol recommendation.
3.3.
Duration of Treatment
The cycle length is 28 days. Patients will receive study treatment until disease progression, 
relapse, loss of clinical benefit, unacceptable toxicities, or until they meet other study treatment 
discontinuation criteria.


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3.4.
Protocol-Specific Stopping Criteria 
Reasons for discontinuation of study treatment may 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)
In the event one or more components of the study treatment (magrolimab/placebo, azacitidine 
and/or venetoclax) are discontinued, the following combinations are permitted:
•
Magrolimab/placebo + azacitidine
•
Azacitidine (single agent)
•
Venetoclax + azacitidine
The following combinations are not permitted:
•
Magrolimab/placebo (single agent)
•
Venetoclax (single agent)
•
Magrolimab/placebo + venetoclax


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If azacitidine is permanently discontinued, the patient must discontinue the remaining study 
treatment.
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.
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 and participate in long-term follow-up and survival 
assessment if the patient does not start a new anti-AML therapy.
Patients who discontinue study treatment are to return for an end-of-treatment (EOT) visit for 
evaluation of safety within 7 days (± 7 days) of their last dose or the decision to end study 
treatment, whichever is 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 – this is only applicable after the 30 day visit/call.
All patients who discontinue study treatment for reasons other than death or start of new 
anti-AML therapy (except maintenance and SCT) will participate in long-term follow-up for 
disease response 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 aspirate results will continue 
until start of new anti-AML therapy (except post SCT maintenance) (Appendix Figure 1). 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/placebo is recommended prior to SCT.
All patients will be followed for survival until death, withdrawal of consent, loss to follow-up, 
completion of survival follow-up, or study termination by the sponsor, whichever occurs first. 
Duration of survival follow-up will be limited to 5 years from the EOT visit for each patient. If a 
patient discontinues study treatment and does not consent to continued follow-up, the 
investigator must not access confidential records that require the patient’s consent. However, an 
investigator may consult public records to establish survival status. 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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If a patient discontinues study dosing (for example, as a result of an AE), every attempt should 
be made to keep the patient in the study and continue to perform the required study-related 
follow-up and procedures. 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 (Appendix Table 5), the investigator may search 
publicly available records (where permitted by local laws and regulations) to ascertain survival 
status unless the patient withdraws consent for such follow-up. This ensures reduced risk of 
missing critical efficacy data.
The assessments to be performed at each of the posttreatment visits are listed in Appendix 
Table 5.
3.5.
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).
Individual Patients: Patients are considered to have reached the end of study when they are no 
longer followed for long-term or survival follow-up (up to 5 years from the EOT visit) due to the 
following reasons: death, loss to follow-up, withdrawal of consent, or sponsor termination of 
study.
3.6.
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, efficacy, and AEs as specified in 
Appendix Table 5. 
3.7.
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 laboratory testing (for PK, ADA and/or PD data), 
patient-reported outcome (PRO) data, and/or additional biomarker testing.


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4.
PATIENT POPULATION
4.1.
Number of Patients and Patient Selection
Approximately 432 patients with newly diagnosed previously untreated AML confirmed by 
histology based on World Health Organization (WHO) criteria who are age 75 years or older, or 
who are age 18 years to 74 years and have comorbidities that preclude the use of intensive 
induction chemotherapy will be enrolled into the study.
Every effort will be made to include patients of any race, gender, and across the age range 
described in the study inclusion and exclusion criteria provided in Section 4.2 and Section 4.3 of 
the protocol.
4.1.1.
Patient Replacement
Patients who discontinue before the end of study will not be replaced.
4.2.
Inclusion Criteria
Patients must meet all of the following inclusion criteria to be eligible for participation in this 
study:
1) Previously untreated patients with histological confirmation of AML by 2016 WHO criteria 
who are ineligible for treatment with a standard cytarabine and anthracycline induction 
regimen due to age, or comorbidity. Patients must be considered ineligible for intensive 
chemotherapy, defined by the following:
a) ≥ 75 years of age;
Or
b) ≥ 18 to 74 years of age with at least 1 of the following comorbidities:
i)
Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
ii) Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory 
volume in 1 second ≤ 65%
iii) Left ventricular ejection fraction ≤ 50%
iv) Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the 
Cockcroft Gault formula or measured by 24-hour urine collection
v) Hepatic disorder with total bilirubin > 1.5  upper limit of normal (ULN)
vi) Any other comorbidity that the investigator judges to be incompatible with intensive 
chemotherapy that must be approved by the sponsor’s medical monitor before study 
enrollment


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2) ECOG performance status:
a) Of 0 to 2 for subjects ≥ 75 years of age
Or
b) Of 0 to 3 for subjects ≥ 18 to 74 years of age
3) 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/placebo dose during Cycle 1.
NOTE: Patients can be treated with hydroxyurea and/or leukapheresis prior to randomization 
and throughout the study to reduce the WBC to ≤ 20  103/µL to enable eligibility for study 
drug dosing.
4) Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment based on complete 
blood count (CBC) result.
NOTE: Transfusions are allowed to meet hemoglobin eligibility (Section 5.5.3).
5) Patient has provided informed consent.
6) Patient is willing and able to comply with clinic visits and procedures outlined in the study 
protocol.
7) Male or female, ≥ 18 years of age
8) Patients must have adequate renal function as demonstrated by a creatinine 
clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour 
urine collection.
9) Adequate liver function as demonstrated by:
a) aspartate aminotransferase ≤ 3.0  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 
d) Patients ≥ 18 to 74 years of age may have total bilirubin ≤ 3.0  ULN
10) Pretreatment RBC phenotype or genotype completed (Section 7.8.1)


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11) Male and female patients of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol-specified method(s) of contraception.
12) Patients must be willing to consent to mandatory pretreatment and on-treatment bone marrow 
assessments (aspirate and trephines). For France-specific requirements regarding bone 
marrow assessments, please see Appendix 15.
4.3.
Exclusion Criteria
Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this 
study:
1) Positive serum pregnancy test
2) Breastfeeding female
3) Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
4) Patients receiving any live virus vaccine within 4 weeks prior to initiation of study 
treatments. 
5) Prior treatment with any of the following:
a) CD47 or SIRPα-targeting agents
b) Antileukemic therapy for the treatment of AML (eg, HMAs, low-dose cytarabine, and/or 
venetoclax), excluding hydroxyurea
NOTE: Patients with prior myelodysplastic syndrome (MDS)/myeloproliferative 
neoplasm (MPN) who have not received prior HMAs or venetoclax or chemotherapeutic 
agents for MDS/MPN may be enrolled in the study. Prior treatment with MDS/MPN 
therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or 
similar RBC-, WBC-, or platelet-direct therapies or growth factors is allowed for these 
patients.
6) Current participation in another interventional clinical study
7) Known inherited or acquired bleeding disorders
8) Patients who have received treatment with strong and/or moderate CYP3A inducers (eg, such 
as preparations containing St. John’s wort) within 7 days prior to the initiation of study 
treatments
9) Patients 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 and are unwilling to discontinue consumption of these throughout the receipt 
of study drug


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10) Patients who have malabsorption syndrome or other conditions that preclude enteral route of 
administration
11) Clinical suspicion of or documented active central nervous system (CNS) involvement with 
AML
12) Patients who have acute promyelocytic leukemia
13) 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 infection, and congestive heart failure 
New York Heart Association Class III to IV.
14) Known history, diagnosis, or suspicion of Hemophagocytic Lymphohistiocytosis (HLH) 
Syndrome.
15) 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.
NOTE: Localized non-CNS radiotherapy, erythroid and/or myeloid growth factors, hormonal 
therapy 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.
16) Known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or 
HIV infection in medical history within 3 months of study entry.
17) Active HBV, and/or active HCV, and/or HIV following testing at screening:
a) Patients who test positive for hepatitis B surface antigen and patients who test positive for 
hepatitis B core antibody will require HBV DNA by quantitative polymerase chain 
reaction (PCR) for confirmation of active disease.
b) Patients who test positive for HCV antibody will require HCV RNA quantitative PCR for 
confirmation of active disease.
c) Patients who test positive for HIV antibody will require viral load testing; those who have 
an undetectable viral load in the prior 3 months may be eligible for the study.


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5.
STUDY DRUGS
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 
interactive response technology (IRT) to either the experimental arm or the control arm. The first 
dose of study treatment should be administered within 72 hours of randomization.
To achieve balance between treatment arms, randomization will be stratified according to the 
following factors:
•
age (< 75 years, ≥ 75 years)
•
genetic risk group (favorable/intermediate, adverse, unknown)
•
geographic region (US, outside the US)
The randomization list will be generated with a 3-factor stratified block randomization by 
Signant Health (https://www.signanthealth.com/) using SAS statistical software.
5.1.2.
Blinding
During the randomized phase, the investigators, the study site personnel, the patients, the study 
management team, and all personnel directly involved with the conduct of the study will remain 
blinded to treatment assignment until the primary analysis of OS.
Specified personnel may be unblinded based on their study role. The Pharmacokinetics File 
Administrator, or designee, in Bioanalytical Operations and/or Clinical Data Management who 
facilitates the data transfer of PK files between Gilead and vendors will remain unblinded. 
Individuals in Clinical Packaging and Labeling or Clinical Supply Management who have an 
Unblinded Inventory Manager role in the IRT for purposes of study drug inventory management 
will remain unblinded. Individuals in Patient Safety (PS) who are responsible for safety signal 
detection, investigational new drug safety reporting, and/or expedited reporting of suspected 
unexpected serious adverse reactions may be unblinded to individual case data and/or 
group-level summaries. External (ie, contract research organization [CRO], independent data 
monitoring committee [DMC]) biostatisticians and programmers responsible for preparing 
interim tables, listings, and figures for the DMC will be unblinded. The laboratories that will 
store and/or analyze blood samples for conducting PK and ADA analysis will be unblinded. 
Regulatory Quality and Compliance personnel in Research and Development may also be 
unblinded for purposes of supporting quality assurance activities and/or regulatory agency 
inspections.
The sponsor study team will remain blinded until the primary analysis of OS.


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5.1.3.
Planned Interim Unblinding
To assess the safety and efficacy of magrolimab + venetoclax + azacitidine and for the interim 
analysis planning and program development consideration, a DMC independent of the blinded 
study team will be assembled. The DMC will be granted access to unblinded clinical data, 
including treatment assignments, to closely monitor study progress and drug safety. The 
membership, conduct, and meeting schedule of the DMC will be documented in the DMC 
charter.
A Gilead internal unblinded team independent of the blinded study team may be assembled, to 
assess the safety and/or efficacy of magrolimab + venetoclax + azacitidine for planning and 
development purposes. This group will consist of at least 1 representative from Clinical 
Research, Biostatistics, and Global Patient Safety, and may include other personnel as necessary. 
The Gilead medical monitor and clinical research personnel directly interacting with the study 
center will not be unblinded to the patient treatment assignment. The Gilead internal unblinded 
team will be granted access to unblinded clinical data at the group summary level including 
treatment assignments to closely monitor study progress and drug safety. 
The membership, conduct, and meeting schedule of the internal unblinded team will be 
documented in the Gilead Data Review Committee Charter as specified in Gilead procedural 
documents.
At the time of the second interim analysis, the DMC will review the unblinded analysis results. If 
the null hypothesis on OS is rejected, and Gilead determines to start the marketing application 
process, the Gilead study team may remain blinded, and a separate Gilead internal team 
responsible for the marketing application may be assembled, and unblinded for all enrolled 
patients and remain blinded for future patients. This group will consist of at least 1 representative 
from Clinical Research, Biostatistics, and Global Patient Safety, and may include other personnel 
as necessary.
5.1.4.
Procedures for Breaking the Blind on Treatment Codes
In the event of a medical emergency requiring breaking the blind to provide medical care to the 
patient, the investigator may obtain the patient’s treatment assignment directly from the IRT for 
that patient (IRT vendor may be contacted in case of technology failure). Gilead recommends but 
does not require that the investigator contact the Gilead medical monitor before breaking the 
blind. Treatment assignment should remain blinded unless that knowledge is necessary to 
determine patient emergency medical care. The rationale for unblinding must be clearly 
explained in source documentation along with the date on which the treatment assignment was 
obtained. The investigator is requested to contact the Gilead medical monitor promptly in case of 
any treatment unblinding.
Blinding of study treatment is critical to the integrity of this clinical study. Therefore, if a 
patient’s treatment assignment is disclosed to the investigator, the patient will have study 
treatment discontinued. All patients will be followed until study completion unless consent to do 
so is specifically withdrawn by the patient. During long-term or survival follow-ups, patients can 
receive new anti-AML therapy as per investigator’s judgment.


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5.2.
Description and Handling of Magrolimab and Placebo
5.2.1.
Formulation
Magrolimab is formulated as a sterile, clear, preservative-free liquid intended for IV 
administration containing 10 mM sodium acetate, 5% (weight-to-volume ratio [w/v]) sorbitol, 
0.01% (w/v) polysorbate 20 at a 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.
Placebo for magrolimab is formulated as a sterile, clear, preservative-free liquid intended for IV 
administration containing 10 mM sodium acetate, 5% (weight-to-volume ratio [w/v]) sorbitol, 
0.01% (w/v) polysorbate 20 at a pH of 5.0 without magrolimab. Each vial is manufactured to 
ensure a deliverable volume of 10 mL.
5.2.2.
Packaging and Labeling
Magrolimab and placebo are 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 Food and Drug Administration (FDA), EU 
Guidelines to Good Manufacturing Practice, Annex 13 (Investigational Medicinal Products), 
and/or other local regulations. 
5.2.3.
Storage and Handling
Magrolimab/placebo vials should be stored at 2°C to 8°C (36°F to 46°F). Magrolimab/placebo 
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.
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 Venetoclax
5.3.1.
Formulation
Information regarding the formulation of venetoclax can be found in the local prescribing 
information {VENCLEXTA 2020}.
5.3.2.
Packaging and Labeling
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 Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations. 


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Alternatively, in alignment with local regulations, commercial product may be sourced locally by 
the site.
5.3.3.
Storage and Handling
Further information regarding storage and handling of venetoclax is available in the local 
prescribing information.
5.4.
Description and Handling of Azacitidine
5.4.1.
Formulation
Information regarding the formulation of azacitidine can be found in the local prescribing 
information.
5.4.2.
Packaging and Labeling
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 Guidelines to Good Manufacturing 
Practice, Annex 13 (Investigational Medicinal Products), and/or other local regulations. 
Alternatively, in alignment with local regulations, commercial product may be sourced locally by 
the site. 
5.4.3.
Storage and Handling
Further information regarding storage and handling of azacitidine is available in the local 
prescribing information.
5.5.
Dosage and Administration of Study Drugs
5.5.1.
Dose and Administration of Magrolimab/Placebo
The magrolimab/placebo dosing regimen is presented in Table 6. The treatment schedule is 
provided in Appendix Table 2.
Premedication requirements are provided in Section 5.5.4.
Magrolimab/placebo will be administered by IV infusion. The duration of infusion will be 
3 hours (± 30 minutes) for the first 3 doses of magrolimab/placebo, and then 2 hours 
(± 30 minutes) for infusions beyond the first 3 doses. Magrolimab/placebo doses should not be 
given on consecutive days. 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.
During the first 4 weeks of treatment, WBC count must be ≤ 20  103/µL prior to each 
magrolimab/placebo dose. 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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Within 24 hours prior to each of the first 2 doses of magrolimab/placebo infusion during initial 
treatment, all patients must have a documented hemoglobin ≥ 9 g/dL based on CBC result. 
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/placebo (Section 5.5.3.1).
Hemoglobin must be checked again 3 to 6 hours after the initiation of the first and second doses 
of magrolimab/placebo 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.
All patients should be monitored hourly during infusion and for 1 hour after infusion for priming, 
repriming/re-escalation, and maintenance doses during the 4 first weeks. Patients should be 
monitored (including measurement of vital signs, as clinically appropriate) for signs and 
symptoms of IRR, which have been observed in previous magrolimab studies. Postinfusion 
monitoring should begin after the infusion is complete. Postinfusion 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.
The dose of magrolimab/placebo will be calculated based on actual weight at randomization 
(using weight obtained either at screening or on Cycle 1 Day 1) and remains 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.
Patients will continue study treatment until they show evidence of disease progression, relapse, 
loss of clinical benefit, or unacceptable toxicity (further details about treatment discontinuation 
are provided in Sections 3.3 and 3.5).
5.5.1.1.
Treatment Delay and Repriming/Re-escalation for Magrolimab/Placebo
Given the large CD47 antigen sink on normal cells, patients who have a long dose delay of 
magrolimab/placebo are required to be reprimed with magrolimab dosing to resaturate the CD47 
antigen sink. Guidelines for repriming/re-escalation for magrolimab/placebo after a dose delay 
are provided in Section 5.5.1.2.
5.5.1.2.
General Guidance on Dose Modification and Delays for Magrolimab/Placebo
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/placebo may be allowed in certain circumstances 
(eg, with certain AEs), with approval by the sponsor. If treatment-emergent and/or 
magrolimab/placebo-related AEs occur, magrolimab/placebo may be withheld until clinical 
resolution or improvement per the treating physician.


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When the combination drugs (azacitidine or venetoclax) are delayed due to toxicities, 
magrolimab/placebo should continue independently as per magrolimab/placebo administration 
schedule (Appendix Table 3). Continuous dosing of magrolimab is needed to maintain 
efficacious exposures; prolonged delays of greater than 1 week when magrolimab is dosed every 
2 weeks have been seen to result in lower clinical efficacy. Magrolimab/placebo may be 
withheld for magrolimab-related AEs: if magrolimab is withheld due to toxicities, any delay 
longer than 3 days should be discussed with the medical monitor.
The repriming guidelines presented in Table 7 should be followed for patients with dose delays. 
In case of repriming, assessments should follow magrolimab repriming table (Appendix 
Table 4).
Table 7.
Repriming Guidelines for Magrolimab/Placebo
Dose of Magrolimab/Placebo
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 are needed for patients on study treatment, magrolimab/placebo 
will be delayed and restarted in accordance with Table 8.
Table 8.
Magrolimab/Placebo Dosing Guidance for Planned Surgical 
Procedures During the Study
Planned Surgical Procedure
Magrolimab/Placebo Dose Guidance
Minimally invasive procedure
(Examples: biopsiesa [excluding lung/liver], 
skin/subcutaneous lesion removal, 
cataract/glaucoma/eye surgery/cystoscopy)
Hold magrolimab/placebo 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/angiopathy)
Hold magrolimab/placebo 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/placebo dose 7 days prior to procedure 
and restart after 7 days
CNS = central nervous system
a
Study drug should not be held for bone marrow biopsy
5.5.2.
Dosage and Administration of Azacitidine and Venetoclax
The azacitidine and venetoclax dosing regimen is presented in Table 6. The treatment schedule is 
provided in Appendix Table 2.


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The start of the cycle is the first day of azacitidine treatment. Venetoclax is to be administered 
along with azacitidine on Day 1 of each cycle.
Azacitidine administration should be completed at least 1 hour before magrolimab/placebo 
administration on days when both drugs are administered. 
Azacitidine will be administered according to region-specific drug labeling, either 
subcutaneously (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 7 doses of azacitidine are 
administered within 9 consecutive days in accordance with local clinical practice guidelines. 
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 local prescribing information for detailed 
instructions for preparation and administration).
The dose of azacitidine will be calculated based on actual weight and height obtained either at 
screening or on Cycle 1 Day 1 and remains 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.
Once the patient has completed the first cycle of treatment, azacitidine may be administered at 
home only on days where magrolimab/placebo is not given and azacitidine is administered alone.
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.
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.
For patients taking concomitant CYP3A and P-glycoprotein (P-gp) inhibitors, refer to Table 13 
for venetoclax dosing and administration.


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5.5.2.1.
Venetoclax Administration and Tumor Lysis Syndrome
Patients treated with venetoclax may develop tumor lysis syndrome (TLS). 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 TLS at predose, 6 to 8 hours after each new dose during ramp-up (Days 1, 2, and 
3), and 24 hours after reaching the maintenance dose.
5.5.3.
Management of Specific Adverse Events and Dose Modification/Delays of 
Study Drugs 
Dose modification and treatment delay of azacitidine may not occur for patients in the initial 
28-day period (Cycle 1).
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.
General guidance about magrolimab/placebo dose modifications is available in Section 5.5.1.2.
5.5.3.1.
Management of Hematologic Toxicity
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, any of the 4 blood groups A, B, AB, and O composing the ABO system 
(ABO)/Rhesus factor (Rh) type, antibody screen, blood phenotyping or genotyping, and direct 
antiglobulin test (DAT) need to be performed at screening before exposure to magrolimab, as 
described in Section 5.5.3.1.1.
Red blood cell 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.
5.5.3.1.1.
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 to 1.5 g/dL observed in the first 1 to 2 weeks of 
treatment. This decrease in hemoglobin level is acceptable in patients with no other significant 
diseases or medical conditions. However, for patients with significant diseases or medical 


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conditions, such as unstable angina, ischemic heart disease, or uncontrolled diabetes mellitus, 
treatment‑related anemia could be life‑threatening or fatal. Significant drops (2 g/dL or higher) 
have been observed in early doses.
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 based on CBC result. 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.
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 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) 
will 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 recent transfusion). Results must be available before the first dose of 
magrolimab.
5.5.3.1.1.1.
Management in Patients with Cardiac Comorbidities
Patients with cardiac history (e.g. LVEF ≤ 50%), especially those with low baseline hemoglobin 
levels, must be monitored closely after initial administrations of magrolimab/placebo as pre-
existing anemia could be exacerbated. Enhanced monitoring of hemoglobin with extra CBC and 
careful fluid management, including diuretic administration, during or post transfusion may be 
required for these patients, as clinically needed.
5.5.3.1.1.2.
For Patients After Exposure to Magrolimab/Placebo
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.
5.5.3.1.1.3.
Blood Components for Transfusion 
For all elective RBC and platelet transfusions, use leukocyte-reduced and gamma-irradiated units 
per institutional guidelines.
For RBC transfusions, phenotype/genotype matched units are preferred. However, 
cytomegalovirus (CMV)-seronegative units for CMV-seronegative patients will not be required 
for this study.


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In case ABO/Rh type cannot be resolved, use pretreatment (historical) phenotype/genotype 
matched units 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 use of 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}.
5.5.3.1.2.
Neutropenia and Thrombocytopenia:
Neutrophil counts may worsen after administration of magrolimab, leading to severe 
neutropenia. Grade 3 (ANC 500 to < 1000 cells/uL) and Grade 4 (ANC < 500 cells/uL) 
neutropenia have been reported. Additionally, fatal events of febrile neutropenia have been 
reported in patients treated with magrolimab. Close hematological monitoring is required for all 
patients during treatment. In cases of neutropenia, consider antimicrobial prophylaxis and 
administration of granulocyte-colony stimulating factor (G-CSF) if clinically appropriate. If 
febrile neutropenia occurs, administer antibiotics and/or antimycotics.
Dose modification guidelines for magrolimab in the case of severe neutropenia or 
thrombocytopenia are provided below:
•
Before achieving remission (ie, bone marrow blast count < 5%), for Grade 4 neutropenia 
(ANC < 500/uL) with or without fever or infection, delay of magrolimab/placebo dosing is 
not recommended. In cases of Grade 4 neutropenia with serious infection, recommendations 
for dose delay are provided in Section 5.5.3.2.2. 
•
After achieving remission, for Grade 4 neutropenia (ANC < 500/uL) with or without fever or 
infection, and lasting at least 14 days, magrolimab/placebo dose delay is required. Upon 
resolution to Grade ≤ 2, resume magrolimab/placebo at the same dose. 
•
Before achieving remission, for Grade 4 thrombocytopenia, delay of magrolimab/placebo 
dosing is not recommended.
•
After achieving remission, for Grade 4 thrombocytopenia lasting at least 14 days, 
magrolimab/placebo dose delay is required. Upon resolution to Grade ≤ 2, resume 
magrolimab/placebo at the same dose.
Dose modifications and delays of venetoclax and/or azacitidine due to neutropenia and 
thrombocytopenia should follow Table 9. 


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Table 9.
Dose Modifications and Delays of Venetoclax and/or Azacitidine for 
Neutropenia and Thrombocytopenia
Event
Occurrence
Action Taken for Venetoclax and/or Azacitidinea
Occurrence prior to 
achieving remissionb
In most instances, venetoclax and azacitidine cycles 
should not be interrupted due to cytopenia prior to 
achieving remission. 
First occurrence after 
achieving remission 
and lasting at least 
7 daysc,d
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and decrease the duration to 21 days. 
Resume azacitidine at the same dose.
Second occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and decrease the duration to 14 days. 
Resume azacitidine at the same dose.
Third occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (14 days) and reduce the 
azacitidine dose to 50 mg/m2.
Fourth occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose, decrease the duration to 7 days, and 
continue the azacitidine dose at 50 mg/m2.
Fifth occurrence in 
cycles after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (7 days) and decrease the 
azacitidine dose to 37.5 mg/m2.
Sixth occurrence and 
beyond in cycles after 
achieving remission 
and lasting 7 days or 
longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, resume venetoclax therapy 
at the same dose and duration (7 days) and decrease the 
azacitidine dose to 25 mg/m2.
Grade 4 neutropenia with 
or without fever or 
infection; or Grade 4 
thrombocytopenia
Seventh occurrence 
and beyond in cycles 
after achieving 
remission and lasting 
7 days or longer
Delay subsequent treatment cycle of venetoclax and 
azacitidine and monitor blood counts. Once the toxicity 
has resolved to Grade 1 or 2, stop venetoclax and 
resume azacitidine at the same dose of 25 mg/m2.
a
Transfuse blood products and administer prophylactic and treatment anti-infectives as clinically indicated. 
b
Remission denotes a bone marrow blast count < 5%. 
c
Administer granulocyte colony-stimulating factor if clinically indicated for Grade 4 neutropenia after remission is achieved.
d
Also applies to patients with Grade 4 neutropenia with blast noted to be < 5% in the first remission bone marrow.
If, per dosing modification in Table 9, the patient is eligible to start the cycle but the cycle is 
delayed, investigator should contact the medical monitor.


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The start of the subsequent cycle should not be delayed beyond 2 weeks if the clinical condition 
allows safe resumption of the cycle. If the start of subsequent cycle is delayed beyond 2 weeks, 
the investigator should contact the medical monitor.
If after the venetoclax and azacitidine dosing schedule modifications, patients do not experience 
Grade 4 neutropenia or Grade 4 thrombocytopenia for at least 2 cycles, physicians can consider 
escalating the venetoclax and azacitidine doses to their immediate previous higher dosing regimens.
5.5.3.2.
Management of Nonhematologic Toxicity
5.5.3.2.1.
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 6). For the 
purposes of this study, the time frame for IRR assessment is the 24-hour period beginning from 
the start of the infusion. Premedication as described in Section 5.5.4 will be used to manage 
IRRs preemptively.
Recommendations for the management of infusion-related reactions related to magrolimab are 
provided in Table 10.
Table 10.
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 an IRR 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/placebo 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/placebo will be administered at that visit.
Patients who experience IRRs with the first ( x) doses of magrolimab should 
continue premedication with corticosteroids prior to subsequent doses at the 
investigator’s discretion. 
The amount of magrolimab/placebo 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.


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Infusion-Related Reactions
CTCAE Grade 
Management
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/placebo.
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.
Patients who have Grade 4 infusion-related reactions will be permanently 
discontinued from study treatment. 
Patients who experience Grade 3 infusion-related reactions 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 Grade 3 
infusion-related reaction will be permanently discontinued from the study 
treatment.
For anaphylaxis, investigators should follow their institutional guidelines for 
treatment.
All patients with ≥ Grade 3 infusion-related reactions will be observed until 
the AE resolves or stabilizes, with vital sign measurements and additional 
evaluations as medically indicated for the management of the AEs.
AE = adverse event; eCRF = electronic case report form; IV = intravenous
5.5.3.2.2.
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 (e.g. fluoroquinolone) or antifungal agents 
(e.g. oral triazoles or parenteral echinocandin) in accordance with current guidelines
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/placebo.
Dose modification guidelines for delay of azacitidine or venetoclax due to serious infections are 
provided in Section 5.5.3.2.7.


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5.5.3.2.3.
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 11 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 11.
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/placebo 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/placebo 
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/placebo 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/placebo 
therapy. Consider interrupting 
azacitidine
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).
Venetoclax does not need to be dose modified or delayed for pneumonitis.
CT = computed tomography; CTCAE = Common Terminology Criteria for Adverse Events; CXR = chest x-ray; IV = intravenous.
5.5.3.2.4.
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.
5.5.3.2.5.
Renal Abnormalities
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 ≥ 2fold 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. In these cases, magrolimab/placebo and venetoclax should not be dose modified or 
dose delayed.
5.5.3.2.6.
Tumor Lysis Syndrome
Refer to Section 5.5.2.1 for information about TLS.


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5.5.3.2.7.
Other Non-hematologic Toxicities 
For venetoclax related or venetoclax -related nonhematologic toxicities that are ≥ Grade 3 that do 
not resolve to  Grade 1 or baseline levels with adequate supportive care, and are clinically 
relevant, venetoclax dosing should be held until resolution to Grade 2 or lower or baseline levels. 
While venetoclax is held, magrolimab/placebo + azacitidine treatment can be continued.
For other azacitidine only related nonhematologic toxicities or nonhematological toxicities that 
do not resolve after holding venetoclax 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 12.
Table 12.
Dose Modification of Azacitidine for Nonhematologic Toxicities
Azacitidine Dosing Instructions If Recoverya Is Not Achieved Within 14 Days
Toxicity
First Occurrenceb
Second Occurrenceb
Third Occurrenceb
Grade 3 or higher 
nonhematologic 
adverse events that 
are clinically 
relevant
Reduce azacitidine dose 
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.
Reduce azacitidine dose 
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.
Reduce azacitidine dose 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 to baseline grade.
If the other non-hematological toxicities are considered to be related to magrolimab per the 
investigator requiring dose modifications or hold, the investigator should contact the medical 
monitor.
5.5.4.
Premedication and Prophylaxis
Premedication is required prior to the administration of the first 4 doses of magrolimab/placebo 
and in case of reintroduction with repriming. Recommended premedication should include oral 
acetaminophen, an antihistamine (IV or oral) and corticosteroid prophylaxis (IV or oral) before 


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the initial doses of magrolimab or in the case of repriming of magrolimab. 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. Patients who subsequently experience any Grade 4 IRRs or recurrent 
Grade 3 IRRs after premedication with corticosteroids should be permanently discontinued from 
magrolimab treatment. 
Recommended premedications are oral acetaminophen (650 to 1000 mg), oral or IV 
diphenhydramine (25 to 50 mg), and IV dexamethasone (4 to 20 mg), or comparable regimen. If 
less than 4 hours has elapsed since a prior dose of acetaminophen has been given, the dose of 
acetaminophen premedication may be omitted.
Prior to the first dose of venetoclax, provide patients with prophylactic measures including 
adequate hydration and antihyperuricemic agents per standard of care 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 but may 
be administered per local institutional guidelines or investigator discretion.
5.6.
Prior and Concomitant Medications: Prohibited Concomitant Medications
Anti-leukemia therapies including chemotherapy (with the exception of hydroxyurea and/or 
leukapheresis), 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}.
Premedication, as well as prophylaxis for AEs as described in Sections 5.5.3 and 5.5.4, 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 RANKL inhibitors are permitted.
Red blood cell and platelet transfusions are permitted during screening and prior to enrollment to 
ensure adequate hemoglobin level according to investigators’ 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 
transfusions during the study.
Hydroxyurea and/or leukapheresis can be used throughout the study to reduce the WBC to 
≤ 20  103/µL. In nonclinical studies, co-administration 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 


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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 70-day safety follow-up calls/visits should be recorded in the eCRF.
Concomitant use of venetoclax with strong CYP3A inducers or moderate CYP3A inducers 
should be avoided, as use with a strong CYP3A inducer decreases venetoclax Cmax, which may 
decrease venetoclax efficacy.
Conversely, concomitant use of strong and moderate CYP3A inhibitors with venetoclax 
increases exposure to venetoclax and therefore may increase the risk of venetoclax-related 
toxicity including TLS. Venetoclax dose modification based on concomitant use of a strong or 
moderate CYP3A inhibitor or P-gp inhibitor at initiation, during, or after the ramp-up phase, is 
described in Table 13. 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 about drug interactions with venetoclax, refer to the local prescribing 
information.
Table 13.
Management of Potential Venetoclax Interactions with CYP3A and 
P-gp Inhibitors
Co-administered Drug
Initiation and Ramp-up 
Phase
Steady Daily Dose (After Ramp-up Phase)
Posaconazole
Day 1 – 10 mg venetoclax
Day 2 – 20 mg venetoclax
Day 3 – 50 mg venetoclax
Day 4 – 70 mg venetoclax
Reduce venetoclax dose to 70 mg
Other strong CYP3A inhibitor 
Day 1 – 10 mg venetoclax
Day 2 – 20 mg venetoclax
Day 3 – 50 mg venetoclax
Day 4 – 100 mg venetoclax
Reduce venetoclax dose to 100 mg
Moderate CYP3A inhibitor 
P-gp inhibitor
Reduce the venetoclax dose by at least 50%
CYP3A = cytochrome P450 enzyme 3A; P-gp = P-glycoprotein 


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5.6.1.
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 absolute neutrophil count 
(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.
5.7.
Accountability for Investigational Medicinal Product
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug provided by the sponsor (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.
Each study site must keep accountability records that capture:
•
The date received and quantity of study drug (kits, vials, etc.).
•
The date, patient number, and the study drug kit and/or lot number dispensed
•
The date, quantity of used and unused study drug returned, along with the initials of the 
person recording the information, in line with local practice.
5.7.1.
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 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.
For both disposal options listed above, the study monitor must first perform drug accountability 
during an on-site monitoring visit.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each patient in the study are presented in tabular form 
in Appendix 3 and described in the text that follows.
The investigator must document any deviation from the protocol procedures and notify Gilead or 
the CRO.
6.1.
Patient Enrollment and Treatment Assignment
Entry into screening does not guarantee enrollment into 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. 
Patients who are determined to not be eligible after screening may be rescreened once at the 
discretion of the investigator. Rescreening must be discussed with and approved by the study 
medical monitor on a case-by case basis. Patients who are determined to be eligible for 
rescreening must be reconsented with a new screening number assigned. 
6.2.
Pretreatment Assessments
6.2.1.
Screening Visit
Screening assessments are outlined in Appendix Table 1.
Patients will be screened within 30 days before randomization to determine eligibility for 
participation in the study. Data from assessments performed as part of standard of care prior to 
informed consent signature may be used if they are within the required screening period. The 
following will be performed and documented at screening:
•
Obtain written informed consent
•
Obtain demographics and medical history, including AML history, AML molecular marker 
results at diagnosis, if available, and date of most recent RBC and/or platelet transfusion(s)
•
Complete physical examination, including vital signs, body weight, and height
•
Serum pregnancy test (females of childbearing potential)
•
CBC with differential, platelets, reticulocytes, and blasts
•
Serum or plasma chemistry as defined in Table 14
•
Serology for HBV, HCV, and HIV
•
Prothrombin time (PT) or international normalized ratio (INR), and activated partial 
thromboplastin time (aPTT) or PTT


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•
Blood cell ABO genotyping or phenotyping (phenotyping is acceptable only in patients who 
have not received red blood cell transfusion in the last 3 months) for minor antigens, type, 
and screen (ABO/Rh), DAT (Section 5.5.3.1.1 Anemia, Blood Cross-Matching, and Packed 
Red Blood Cell Transfusion Procedures)
•
Urinalysis
•
Peripheral blood smear (for blasts)
•
Bone marrow biopsy and aspirate for blast evaluation (response assessment), cytogenetics, 
MRD assessment, and biomarker studies. NOTE: Cytogenetic test results from initial 
diagnosis of AML may be used in lieu of screening cytogenetic assessment. Bone marrow 
biopsy (blocks) collected within 1 month prior to signing of informed consent may be used in 
lieu of bone marrow biopsy. 
•
Bone marrow slides or blocks for central review (bone marrow slides or blocks are optional 
if aspirate is provided for central review). NOTE: Bone marrow biopsy collected within 
1 month prior to signing of informed consent may be used in lieu of bone marrow biopsy for 
central review. 
•
ECOG performance status (Appendix 7)
•
Perform 12-lead electrocardiogram (ECG) (single)
•
Echocardiogram or MUGA (only for patients ≥ 18 to 74 years of age with cardiac disease, if 
needed to determine eligibility)
•
Pulmonary function tests (only for patients ≥ 18 to 74 years of age with respiratory disease, if 
needed to determine eligibility)
•
Record any SAEs and all AEs related to protocol-mandated procedures occurring after 
signing of the informed consent form (ICF)
•
Record prior and concomitant medications
•
Eligibility criteria
Assessments performed as part of screening for other magrolimab clinical studies may be 
acceptable for use on this study with sponsor approval.
From the time of obtaining informed consent through the first administration of study drug, 
record all serious AEs (SAEs), as well as any AEs related to protocol-mandated procedures on 
the Adverse Events electronic case report form (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.


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6.2.2.
Baseline/Day 1 Assessments
Baseline/Day 1 assessments are outlined in Appendix Table 1.
Patients must return to the study site within 30 days of screening for baseline/Day 1 assessments.
The following pretreatment assessments will be performed and documented prior to the initial 
dose on Cycle 1 Day 1. Laboratory assessments, vital signs, and physical examination may occur 
up to 72 hours before administration of any study treatment:
•
EORTC QLQ-C30, EQ-5D-5L, and PGIS (must complete these questionnaires before any 
other study procedures at required visits)
•
Vital signs, weight, and symptom-directed physical examination
•
Serum or urine pregnancy test (females of childbearing potential)
•
CBC with differential, platelets, reticulocytes, blasts. Note: Hemoglobin must be ≥ 9 g/dL 
within 24 hours of Day 1 magrolimab/placebo dose (Section 5.5.3.1)
•
Haptoglobin and lactate dehydrogenase
•
Serum or plasma chemistry
•
Recording of all AEs and concomitant medications
•
Peripheral blood sample for biomarker studies
•
PK and ADA sample collection
6.3.
Randomization
Randomization procedures are described in Section 5.1.1.
6.4.
On-Study Treatment Assessments
On-study treatment assessments include evaluations of efficacy (Section 6.5), safety 
(Section 6.6), PK (Section 6.7), immunogenicity (Section 6.8), and biomarkers (Section 6.9). The 
schedule for on-treatment assessments is provided in Appendix Table 1.
6.5.
Efficacy Assessments
Clinical response will be assessed by the investigator using guidelines based primarily on 
European LeukemiaNet (ELN) AML recommendations and International Working Group AML 
response criteria {Cheson 2003, Cheson 2006, Dohner 2017}, with modifications (see 
Appendix 4).


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Response assessments will be done in conjunction with bone marrow assessments, CBC, and 
peripheral blood smear according to the schedule of assessments (Appendix Table 1, Appendix 
Table 5). Peripheral blood smear for blasts should be done on the same day as the bone marrow 
assessment. Complete blood count 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. The date of the response will be the date 
of the bone marrow assessment. If disease progression or relapse is assessed based on CBC 
assessments or new extramedullary disease or both, other than bone marrow blasts assessments, 
then the date of the corresponding CBC or new extramedullary disease assessment date or the 
earlier of these 2 dates will be used as the date of response assessment.
6.5.1.
Bone Marrow Assessments
Bone marrow assessments (including aspirate and/or core/trephine biopsy) are required for 
response assessments (eg, blast evaluation), including conventional cytogenetic analysis per 
institutional standards (Appendix Table 1). In addition, bone marrow specimens may be used for 
biomarker studies, MRD monitoring, 
, and biobanking. Minimal residual 
disease testing and biomarker studies will be performed by a central laboratory. Details for 
preparation and distribution of aspirate and/or biopsy/trephine specimens to the testing 
laboratories will be provided in the laboratory manual for this study. Bone marrow aspirate 
and/or biopsy slides or blocks for efficacy assessments will be prepared for potential evaluation 
of response assessments by independent central review.
If the patient is cytopenic at the time of the bone marrow assessments, CBC is to be monitored at 
least twice per week for 2 weeks or until optimal count recovery is reached (whichever comes 
first).
Patients responding to initial treatment should be re-evaluated regarding their ability to undergo 
allogeneic hematopoietic cell transplant, which may cure a proportion of these patients.
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. Response 
assessments should continue during long-term follow-up approximately every 12 weeks until the 
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 aspirate results will continue until start of a new 
anti-AML therapy (except post SCT maintenance).
If a patient achieves a CR, subsequent bone marrow assessments are still required to be 
performed in accordance with the schedule of assessments.
CCI


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6.5.2.
Peripheral Blood Smear Assessment
Peripheral blood smears for blasts should be collected on the same day as the bone marrow 
aspirates for response assessment per the schedules of assessments (Appendix Table 1, Appendix 
Table 5). These samples should be collected from the arm contralateral to the arm being used for 
drug infusion/injection, if possible. Peripheral blood smears will be assessed locally.
6.5.3.
Patient-Reported Outcomes
Four PRO instruments will be administered in this study: the EORTC QLQ-C30, the EQ-5D-5L, 
the PGIS, and the PGIC. If the PRO instruments are not available in a patient’s language, 
patients are not required to complete the assessments. Patients with other situations related to 
PRO instrument completion (eg, visual impairment/blindness, limitation in upper extremity 
mobility/dexterity) may be exempt from these assessments after discussion with the sponsor.
The patient should complete these questionnaires before any other study procedures at required 
visits. Please refer to the schedules of assessments (Appendix Table 1, Appendix Table 5) for 
timing of PRO assessments.
6.5.3.1.
EORTC QLQ-C30
The EORTC QLQ-C30 is a reliable and valid measure of PROs 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 
(prior week) and it requires approximately 11 minutes to complete. An example is provided in 
Appendix 9.
6.5.3.2.
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 10.
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.
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.


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6.5.3.3.
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 11.
6.6.
Safety Assessments
Safety will be evaluated by incidence of AEs, assessment of clinical laboratory test findings 
(chemistry, hematology), physical examination, 12-lead electrocardiogram, and vital sign 
measurements.
6.6.1.
Pregnancy Test
Pregnancy tests are required only for female patients of childbearing potential. Note that a 
woman is considered to be of childbearing potential following the initiation of puberty (Tanner 
Stage 2) until becoming postmenopausal, unless permanently sterile or with medically 
documented ovarian failure. Permanent sterilization includes hysterectomy, bilateral 
oophorectomy, or bilateral salpingectomy in a female patient of any age. 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 < 54 years of 
age with amenorrhea of ≥ 12 months may also be considered postmenopausal if their follicle-
stimulating hormone level is in the postmenopausal range and they are not using hormonal 
contraception or hormonal replacement therapy. A negative serum pregnancy test is required at 
screening, and a negative urine 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 before study treatment 
administration. Serum or urine pregnancy tests will also be required every 4 weeks thereafter 
(Appendix Table 1, Appendix Table 5). For further details, refer to Appendix 5.
6.6.2.
Complete Blood Counts
Samples for CBC should be collected per the schedules of assessments in Appendix Table 1 and 
Appendix Table 5. White blood cell counts must be ≤ 20  103/µL prior to first dose of study 
drug and prior to each magrolimab/placebo dose for the first 4 weeks (Section 5.5). Additional 
samples for CBC may be collected outside of the protocol-specified time points to ensure WBC 
level ≤ 20  103/µL for the first cycle and repriming/re-escalation 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.


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6.6.3.
Type and Screen and Direct Antiglobulin Test
Refer to Section 5.5.3 for detailed guidance on type and screen and DAT. Specific instructions 
for processing, labeling, and shipping samples will be provided in the central laboratory manual 
as applicable.
6.6.4.
Vital Signs
Vital signs should 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 of study treatment at the visits specified in the schedules of assessments in Appendix 
Table 1 and Appendix Table 5.
6.6.5.
Physical Examination
Complete physical examination should 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.
6.6.6.
Electrocardiograms
A single 12-lead ECG will be performed at screening.
6.6.7.
Echocardiogram or MUGA
An echocardiogram or MUGA will be performed at screening only for patients aged 18 to 
74 years with cardiac disease, if needed to determine ineligibility to intensive chemotherapy. 
Left ventricular ejection fraction (LVEF) is to be reported in the applicable eCRF.
6.6.8.
Pulmonary Function Tests
Pulmonary function tests will be performed at screening only for patients aged 18 to 74 years 
with pulmonary disease, if needed to determine ineligibility to intensive chemotherapy. 
Diffusion capacity of lung (DLCO) or forced expiratory volume during the first second (FEV1) 
are to be reported in the applicable eCRF.
6.6.9.
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.


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6.6.10.
Laboratory Assessments
Laboratory assessments to be performed at screening are presented in Table 14. Laboratory 
assessments to be performed during the study are presented in Table 15.
Table 14.
Laboratory Analyte Listing (to Be Performed at Screening)
Safety Laboratory Measurements 
Chemistry
(Serum or Plasma)
Hematology
Urinalysis
Other Laboratory Measurements
Sodium
Potassium
Chloride
Bicarbonate
Total protein
Albumin
Calcium
Magnesium
Phosphorus
Glucose
BUN or urea
Creatinine
Uric acid
Total bilirubin
Direct bilirubin
Indirect bilirubin
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Hematocrit
Platelets
WBC differential
Absolute neutrophil 
count
Eosinophils
Basophils
Lymphocytes
Monocytes
Reticulocytes
Peripheral Blood 
Smear
Coagulation:
PT/INR
aPTT or PTT
RBC
Protein
Serum pregnancy test
Blood phenotyping and/or genotyping, 
type, and screen (ABO/Rh), DAT
Blasts (peripheral blood smear with bone 
marrow assessments and with CBC)
Hepatitis B and hepatitis C 
assessments: 
HBsAg, anti-HBc, HCV antibody, HBV 
DNA, and HCV RNA, as applicable
Bone marrow aspirate and biopsy:
Response assessment (eg, blast 
evaluation)
Cytogenetics
MRD assessmenta
Biomarker studiesa 
Slides or blocks for independent central 
reviewb
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; ALT = alanine aminotransferase; 
aPTT = activated partial thromboplastin time; AST = aspartate aminotransferase; BUN = blood urea nitrogen; CBC = complete 
blood count; DAT = direct antiglobulin test; INR = international normalized ratio; LDH = lactate dehydrogenase; 
MRD = minimal residual disease; PT = prothrombin time; PTT = partial thromboplastin time; Rh = Rhesus factor; 
SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; WBC = white blood cell
a
These assays will be performed at a central laboratory. 
b
Bone marrow biopsy collected within 1 month prior to signing of informed consent may be used in lieu of bone marrow 
biopsy for central review.


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Table 15.
Laboratory Analyte Listing (to Be Performed During the Study)
Safety Laboratory Measurements
Chemistry
(Serum or Plasma)
Hematologya
Other Laboratory Measurements
Sodium
Potassium
Calcium
Chloride
Bicarbonate
Albumin
Glucose
BUN or urea
Creatinine
Uric acid 
Phosphorus 
Total bilirubin
Direct bilirubin
Indirect bilirubin
Haptoglobin
LDH
AST (SGOT)
ALT (SGPT)
Alkaline phosphatase
Hemoglobin
Platelets
WBC differential
Absolute neutrophil count
Lymphocytes
Reticulocytes
Serum or urine pregnancy test
Pharmacokineticsb
Antidrug antibodiesb
Blasts (with CBC)
Bone marrow aspirate and biopsy:
Response assessment (eg, blast 
evaluation)
Cytogenetics
MRD assessmentb
Biomarker studiesb 
Slides or blocks for independent central 
review
Peripheral blood smear: 
Blasts (with bone marrow assessments)
Peripheral blood:
Biomarker studiesb
ALT = alanine aminotransferase; AST = aspartate aminotransferase; BUN = blood urea nitrogen; C = Cycle; CBC = complete 
blood count; D = Day; LDH = lactate dehydrogenase; MRD = minimal residual disease; SGOT = serum glutamic oxaloacetic 
transaminase; SGPT = serum glutamic pyruvic transaminase; 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
These assays will be performed at a central laboratory.
Refer to Appendix Table 1 and Appendix Table 5 for collection time points.
6.6.11.
Concomitant Medications
All concomitant medications taken by the patient while on study are to be documented. Changes 
in baseline concomitant medication information are 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, 
dose, unit, frequency, 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 schedules of assessments (Appendix Table 1, Appendix Table 5).


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6.7. 
Pharmacokinetics Assessments 
Final 
Amendment 7 
Samples for PK assessment of magrolimab will be collected from all patients predose of 
magrolimab/placebo ( 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 with 
magrolimab/placebo ), in accordance with the schedule of assessments (Appendix Table 1, 
Appendix Table 5). Sennn magrolimab concentrations will be measured by a validated 
1rmnunoassay. 
6.8. 
Immunogenicity Assessments 
Samples for assessment of anti-magrolimab antibodies will be collected from all patients in 
accordance with the schedule of assessments (Appendix Table 1, Appendix Table 5). Antidrng 
antibody assessment will be perfonned using a validated assay following a 3-tiered approach: 
screening, confinnato1y, and titer testing. 
6.9. 
Biomarker Assessments 
Peripheral blood, bone manow aspirate, and trephine biopsy samples will be collected from all 
patients who have provided consent to pa1ticipate in this study. They may be used to evaluate the 
association of systemic and/or tissue-based biomarkers with study drng response, including 
efficacy and/or AEs, dose optimization, and to better understand the biology of AML in general. 
Because biomarker science is a rapidly evolving area of investigation, and AEs in paiticular ai·e 
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 
biomai·kers and assays described below. The testing outlined below is based upon the cmTent 
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 ait knowledge. 
Blood and bone manow samples will be collected to measure biomai·kers, which may include 
but will not be limited to the presence of or changes to irmnune cell populations, secreted protein 
factors, the expression of cell surface mai·kers on either tumor cells or cells of the tumor 
microenvirorunent, and genetic mutations in tumor cells or subclones of tumor cells at the time 
points listed in the schedules of assessments (Appendix Table 1, Appendix Table 5). 
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These samples will also be used for genomic research 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 tr·eatment outcomes, including efficacy, AEs, and the processes of dmg absmption and 
disposition. These specimens may also be used to develop biomarker or diagnostic assays and 
establish the perfo1mance characteristics of these assays. Genomics research may include 
sequencing of genetic material derived from both cancer cells and nonnal cells. Sequencing of 
genetic material derived from cancer cells will be used to better understand the MOA of 
magrolimab combinations in this patient population, and potentially to identify subsets of 
patients who are likely to benefit. Sequencing of genetic material derived from n01mal cells will 
be used to define differences in sequence that are cancer specific. 
Samples collected for biomarker assessments will be desh'oyed no later than 15 years after the 
end of study or per country requirements. Specific instr11ctions for processing, labeling, and 
shipping samples will be provided in the cenh'al laborato1y manual. 
6.9.1. 
Minimal Residual Disease 
Sensitive flow cytometry-based assays are capable of identifying phenotypic leukemia cells 
down to frequencies of less than 1 x 10-3 of total WBCs. These rare leukemia cells are tenned 
MRD, and their presence or absence following h'eatment is an independent prognostic factor for 
disease progression and relapse in all AML tr·eatment paradigms. Patients with AML in this h'ial 
will be assessed by a flow cytometry-based assay for MRD in their bone maITow at multiple time 
points before and after h'eatment during the first 6 c des in order to fmiher understand the 
efficac and MOA of ma ·olimab combinations. 
this study, patients will be tested by both methods, 
and the sensitivity and concordance of the 2 methods may be assessed. Specific instructions for 
processing, labeling, and shipping samples will be provided in the centr·al laborato1y manual. 
6.9.2. 
Leukemia Mutation Profiles and Burden 
The pathogenesis of all cancers, including leukemias, has a basis in their acquired genetic 
mutations. The paiiicular genetic mutations present in a patient's cancer may render it sensitive 
or resistant to anti-cancer therapies, including magrolimab-based combinations. In some cases, if 
str·ongly associated with clinical benefit or the MOA of a dmg, these genetic mutations can be 
used to select patients who ai·e eligible for a given h'eatment. In other cases, the total number of 
mutations present in the genome of a given cancer ( eg, rather than the specific genes mutated) 
can be coITelated with likelihood of response, such as is the case with some T-cell checkpoint 
therapies. Clonal evolution of leukemia cells will also be tr·acked while on h'eatment and at the 
time of relapse, in order to understand the mechanism of resistance to magrolimab combinations. 
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6.9.3. 
Changes in Immune Effector Cell Composition 
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Activation of the immune system can be associated with changes in immune effector cell 
frequency or localization to the tumor microenvironment. In order to explore changes in the 
composition of immune effector cells to infonn MOA, patients with AML in this trial will be 
assessed by methods potentially including, but not limited to, multiplex immunofluorescence and 
single-cell RNA sequencing at multiple pre- and postti·eatment time points. 
6.9.4. 
Changes in Immune Effector Cell Signaling Molecules 
Activation of the immune system can be associated with changes in expression or secretion of 
immune-regulato1y molecules, including cytokines, chemokines, and others. Release of such 
molecules, and their concenti·ation in the peripheral blood or tumor microenvironment can 
info1m MOA. Patients with AML in this u-ial will be assessed for soluble protein factors in the 
peripheral plasma and/or bone maiTow by methods potentially including, but not limited to, 
multiplex enzyme-linked immunosorbent assay or aptamer-based measurement. 
6.9.5. 
Expression of Prophagocytic and Antiphagocytic Signals by Leukemia Cells 
Preclinical studies suggest that the efficacy of magrolimab depends on the balance of pro- and 
antiphagocytic signals expressed by cancer cells. Magrolimab combination therapies, including 
those investigated as pait of this clinical ti·ial, may derive their efficacy from the simultaneous 
blockade of antiphagocytic signals by magrolimab, and the increased expression of 
prophagocytic signals by the companion diug. In order to better define the efficacy and MOA of 
magrolimab combinations in AML, the surface profile of known pro- and antiphagocytic signals 
will be assessed on leukemic cells at multiple pre- and postti·eatment time points using methods 
to include, but not be limited to, flow cytometiy, mass cytometiy , and multiplex 
immunofluorescence. 
-
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6.10. 
Posttreatment Assessments 
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A schematic of the posttreatment visit schedule is presented in Appendix Figure 1. Posttreatment 
assessments are presented in Appendix Table 5. 
6.11. 
Assessments for Early Discontinuation from Study Treatment 
If a patient discontinues study dosing ( eg, 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 6.11.1 ). 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 (Appendix 
Table 5), the investigator may search publicly available records (where pe1mitted by local laws 
and regulations) to asce1tain survival status. This ensures reduced risk of missing critical efficacy 
data. 
6.11.1. 
Criteria for Discontinuation of Study Treatment 
Reasons for discontinuation of study treatment are provided in Section 3.4 
6.11.2. 
End of Study 
The end of the entire study for all patients and for individual patients is defined in Section 3.5. 
6.12. 
Post Treatment Discontinuation Care 
Upon withdrawal from study treatment, patients will receive the care upon which they and their 
physicians agree. Patients will be followed for survival, efficacy and AEs as specified in 
Appendix Table 5. 
For patients who strut new anti-AML therapy (other than SCT) before a relapse, efficacy status 
( done as standard of care) will be collected until relapse. 
6.13. 
Sample Storage 
The stored biological samples may be used by Gilead or its research partner 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 patients 
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 patient administered a study drug 
that 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 AE 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 
during 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


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•
Persistent or significant disability/incapacity
•
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 Serious Adverse Event Definitions
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 fatal. A patient can only have 1 AE 
(SAE) with a fatal outcome and severity of 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 patient.
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 that is above the maximum recommended dose as 
per protocol or in the product labelling (as it applies to the daily dose of the patient in question). 
In cases of a discrepancy in drug accountability, overdose will be established only when it is 
clear that the patient has taken the excess dose(s). Overdose cannot be established when the 
patient cannot account for the discrepancy, except in cases in which the investigator has reason 
to suspect that the patient 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 of which 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, Authorized Auxiliary Medical 
Products, 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, concomitant medication).
•
Yes: There is reasonable possibility that the AE 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).
When there is a reasonable possibility that the causality of the AE/SAE can be assigned to the 
authorized AxMP, the investigator or qualified subinvestigator will need to report the causality 
assessment for the authorized AxMP(s) in accordance with the eCRF. 
7.2.2.
Assessment of Severity
The severity of AEs will be graded using the NCI CTCAE Version 5.0. For each episode, the 
highest grade attained should be reported as defined in the Toxicity Grading Scale (Appendix 6).
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 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.
7.3.3.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occur 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 PS as instructed 
below in this section. This also includes any SAEs resulting from protocol-associated procedures 
performed after the ICF is signed.
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.


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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 PS.
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 Gilead PS (Section 7.4.2). 
Adverse events and SAEs resulting from SSRs must be reported in accordance with 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 occur 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 to Gilead PS 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 do 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.
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 patient identification, 
maintaining the traceability of a document to the patient identifiers.
•
Additional information may be requested to ensure the timely completion of accurate safety 
reports.


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•
Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the patient’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 PS 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 PS
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 PS.
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 PS from study drug initiation throughout the duration of the study, 
including the protocol-required posttreatment follow-up period.
Gilead PS
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 
PS utilizing the paper special situations report form to:
Gilead PS
Email: Safety_FC@gilead.com
or
Fax: 1-650-522-5477


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•
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 PS 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 PS
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.
•
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 PS.
•
The patient should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome of the pregnancy should be reported to Gilead PS 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 PS. Gilead PS 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 European Union 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). 


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In accordance with the European Union 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, electrocardiogram, 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).
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 US FDA 
Guidance for Industry, Drug-Induced Liver Injury: Premarketing Clinical Evaluation {U.S. 
Department of Health and Human Services 2009} as:
• Treatment-emergent ALT or AST elevation (≥ 3  ULN), AND 
• Treatment-emergent total bilirubin elevation (> 2  ULN), and absence of cholestasis (defined 
as ALP < 2  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).


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7.8.
Toxicity Management 
7.8.1.
Magrolimab
Safety management guidelines for magrolimab are described in Section 5.5.3.
7.8.2.
Venetoclax
Safety management guidelines for venetoclax are described in Section 5.5.3. Additional safety 
guidelines are provided in the venetoclax local prescribing information.
7.8.3.
Azacitidine
Safety management guidelines for azacitidine are described in Section 5.5.3. Additional safety 
guidelines are provided in the azacitidine local prescribing information.


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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
The study objectives are provided in Section 2.
8.1.1.
Definition of Primary Efficacy Endpoint
8.1.1.1.
Overall Survival
Overall survival is measured 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 their last known 
alive date.
8.1.2.
Definition of Secondary Efficacy Endpoints
8.1.2.1.
Rate of CR + CRh Within 6 Cycles of Treatment
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 4) within 6 cycles of treatment while on study prior to initiation of any new anti-AML 
therapy or SCT.
8.1.2.2.
Rate of CR Within 6 Cycles of Treatment
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 cycles of treatment, as 
determined by investigators based on the ELN 2017 for AML {Dohner 2017} with modifications 
(Appendix 4) while on study prior to initiation of any new anti-AML therapy or SCT.
8.1.2.3.
Event-Free Survival
Event-free survival 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 cycles 
of treatment), 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 specified events on or prior to data cutoff date 
(the date on which subsequently collected data will not be considered as part of the analysis) will 
be censored at the date of their last response assessment with clear documentation of no relapse 
on or prior to the data cutoff date. Patients will be censored at the date of randomization if no 
response assessment is performed after randomization and the patients do not die.


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8.1.2.4.
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 cycles of treatment 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 on or prior to the data cutoff date. 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.
8.1.2.5.
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 cycles of treatment 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 on or prior to the data cutoff date. 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.
8.1.2.6.
Rate of CR/CRhMRD- Within 6 Cycles of Treatment
The CR/CRhMRD- rate is the proportion of patients who achieve a CRMRD- or CRhMRD- within 
6 cycles of treatment while on study prior to initiation of any new anti-AML therapy or SCT. 
The threshold for MRD negativity in this study is a frequency of less than 1  10-3 phenotypic 
leukemic cells per total WBCs.
8.1.2.7.
Rate of CRMRD- Within 6 Cycles of Treatment
The CRMRD- rate is the proportion of patients who achieve a CRMRD- within 6 cycles of treatment, 
as determined by investigators based on the ELN 2017 for AML with modifications (Appendix 
Table 6), while on study prior to initiation of any new anti-AML therapy or SCT. The threshold 
for MRD negativity in this study is a frequency of less than 1  10-3 phenotypic leukemic cells 
per total WBCs.
8.1.2.8.
Transfusion Independence Conversion Rate
The transfusion independence conversion rate includes both RBC transfusion independence rate 
and platelet transfusion independence rate.
The RBC transfusion independence conversion rate is the proportion of patients who have a 
56-day or longer period with no RBC or whole blood transfusions at any time between the date 
of first dose of study treatment and discontinuation of study treatment among all patients who are 
RBC transfusion dependent at baseline. The RBC transfusion dependence at baseline is defined 
as having received an RBC or whole blood transfusion within the 28 days prior to the first dose 
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The platelet transfusion independence conversion rate is the propo1iion of patients who have a 
56-day or longer period with no platelet transfusions at any time between the date of first dose of 
study treatment and discontinuation of study treatment among all patients who are platelet 
transfusion dependent at baseline. Platelet transfusion dependence at baseline is defined as 
having received a platelet transfusion within the 28 days prior to the first dose of study treatment. 
8.1.2.9. 
Time to First Deterioration on the EORTC QLQ-C30 GHS/QoL Scale 
The TTD on the EORTC QLQ-C30 GHS/QoL scale is defined as time from the date of 
randomization to the time a patient experienced at least 1 threshold value deterioration from 
baseline or death, whichever is earlier. 
8.1.2.10. 
Time to First Deterioration on the EORTC QLQ-C30 Physical Functioning Scale 
The TTD on the EORTC QLQ-C30 physical functioning scale is defined as time from the date of 
randomization to the time a patient experienced at least 1 threshold value deterioration from 
baseline or death, whichever is earlier. 
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8.2. 
8.2.1. 
Planned Analyses 
Interim Analyses 
There will be 2 planned interim analyses for OS. 
8.2.1.1. 
First Interim Analysis 
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The first interim analysis will be perfonned when approximately 121 deaths (40% of the 
expected 303 deaths) have occun ed, outstanding data queries have been resolved or adjudicated 
as unresolvable, and the data have been cleaned and finalized. An administrntive I-sided alpha = 
0.0001 is allocated to this interim analysis. The nonbinding futility analysis with a futility 
boundaiy of HR = 1.1 will be perfo1med. A Gamma beta-spending function with parameter -5 is 
used to obtain the futility boundai·ies for both interim analysis. 
8.2.1.2. 
Second Interim Analysis 
The second interim analysis will be conducted when approximately 227 deaths (75% of the 
expected 303 deaths) have occuned, outstanding data queries have been resolved or adjudicated 
as unresolvable, and the data have been cleaned and finalized. One-sided a = 0.0249 will be 
allocated to the analysis of OS and key secondaiy endpoints in the second interim analysis and 
primaiy analysis. 
The Lan-DeMets approach with O'Brien-Fleming type alpha spending function will be used for 
the interim analysis and primaiy analysis for OS. The stopping boundaries at each analysis time 
are provided in Table 16. If the null hypothesis of OS is not rejected in the second interim 
analysis, the second nonbinding futility test with a futility boundaiy of HR = 0.9 will be 
perfo1med. 
Table 16. 
Stopping Boundaries for Efficacy Superiority Analysis in OS 
Stopping Boundary 
Planned Analysis 
Events(%•) 
HR 
One-sided P Value 
Second interim analysis 
227 (75%) 
0.733 
0.0096 
Prima1y analysis 
303 (100%) 
0.793 
0.022 
HR = hazard ratio 
a 
Info1mation fraction = number of events / number of total events x I 00 
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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 
will be tested for superiority first at the significance level specified in Table 16. If the superiority 
is established, analysis of key secondary efficacy endpoints for superiority 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 17.
The information fraction of EFS at the second interim analysis is calculated based on the 
assumption that median EFS is 9.8 months in patients treated with placebo + venetoclax + 
azacitidine and HR of 0.7. Approximately 292 and 358 EFS events will be observed at the 
second interim and primary analysis per efficacy and enrollment assumptions, respectively, so 
the information fraction is 82% (292/358) at the second interim analysis. 
Table 17.
Definition of Information Fraction
Endpoint
Information Fraction at the Interim Analysis
Rate of CR + CRh within 6 cycles of treatment
Proportion of patients who have at least 7 months follow-up 
since randomization
Rate of CR within 6 cycles of treatment
Proportion of patients who have at least 7 months follow-up 
since randomization
EFS
82%
Rate of CR/CRhMRD- within 6 cycles of treatment 
Proportion of patients who have at least 7 months follow-up 
since randomization
Rate of CRMRD- within 6 cycles of treatment 
Proportion of patients who have at least 7 months follow-up 
since randomization
Transfusion independence conversion rate
Proportion of patients who have at least 9 months follow-up 
since randomization
TTD on the GHS/QoL and the physical 
functioning scales
75%, same with that of OS 
CR = complete remission; CRh = complete remission with partial hematologic recovery; CRMRD- = complete remission without 
minimal residual disease; EFS = event-free survival; GHS/QoL = global health status/quality of life; MRD- = without minimal 
residual disease; OS = overall survival; TTD = time to first deterioration
The key secondary endpoints will be tested in the following order:
•
Rate of CR + CRh within 6 cycles of treatment
•
Rate of CR within 6 cycles of treatment
•
EFS
•
Rate of CR/CRhMRD- within 6 cycles of treatment


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•
Rate of CRMRD- within 6 cycles of treatment
•
Transfusion independence conversion rate
•
TTD on the EORTC QLQ-C30 GHS/QoL scale
•
TTD on the EORTC QLQ-C30 physical functioning scale
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 interim analysis, the DMC will review the unblinded analysis results, and 
provide recommendations. The process details are described in Section 5.1.3 and 8.13.
8.2.1.3.
Data Monitoring Committee Analysis
In addition to the 2 planned interim efficacy analyses, the DMC will convene to review safety 
analysis results periodically.
8.2.2.
Interim Analysis Communication Plan
An interim analysis communication plan describing the processes and procedures that will be 
employed in conducting the prespecified interim efficacy analysis and the controlled 
dissemination of the resulting interim analysis data will be developed and finalized separately. 
The unblinding of specific Gilead personnel will be documented in accordance with the 
appropriate SOPs.
8.2.3.
Primary Analysis
If the null hypothesis on OS is not rejected in the second interim analysis, the unblinded primary 
analysis will be conducted when 303 deaths have occurred. 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. This analysis of the primary endpoint of OS and key 
secondary endpoints will serve as the final analysis for these endpoints and will be used to 
evaluate the efficacy and safety of magrolimab versus placebo in combination with venetoclax 
and azacitidine.
If the null hypothesis of OS is rejected in the second interim analysis, the primary analysis 
timing will be determined by the maturity of the key secondary endpoints that have not been 
rejected in the second interim analysis.
8.2.4.
Final Analysis
The final analysis 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.


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8.3.
Unplanned Analysis
After the discontinuation of study 5F9009, a randomized double-blinded phase 3 study 
evaluating the safety and efficacy of Magrolimab versus Placebo in combination with 
Azacitidine in newly diagnosed, previously untreated patients with higher risk MDS, Gilead 
conducted an ad hoc DMC meeting on 31 August 2023, with OS and safety analysis results 
evaluated by DMC. 
8.4.
Analysis Conventions
8.4.1.
Analysis Sets
8.4.1.1.
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.
The Per-Protocol (PP) Analysis Set will be used in sensitivity analysis of the primary and key 
secondary efficacy endpoints. The PP Analysis Set includes patients in the ITT Analysis Set who 
meet the general criteria defining the target population, are adherent to the protocol, are 
compliant with study drug treatment, and are evaluable for relevant efficacy endpoints. Study 
drug assignment will be designated according to the actual treatment received. The determination 
criteria details of the PP Analysis Set will be listed in the SAP.
8.4.1.2.
Safety
The primary analysis set for safety analysis 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 period up to the last dose plus 70 days will be included in the 
safety summaries.
8.4.1.3.
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.
8.4.1.4.
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.


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8.4.1.5.
Biomarker
The Biomarker Analysis Set includes all randomized patients who received at least 1 dose of any 
study treatment and have at least 1 evaluable biomarker measurement available.
8.4.2.
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.
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. Analysis will be based upon the observed data unless methods 
for handling missing data are specified. If there is a significant degree of non-normality, analysis 
may be performed on log-transformed data or nonparametric tests may be applied, as 
appropriate.
8.5.
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 weight, height, body surface area, body mass 
index, WHO AML classification, and ECOG performance status.
8.6.
Efficacy Analysis
8.6.1.
Analysis of Primary Endpoint
Formal hypothesis testing will be performed to test the statistical hypothesis that the distribution 
of OS between the experimental arm and the control arm 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 arms for 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 
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To assess the robustness of the primary endpoint analysis results, OS will also be compared 
between treatment arms in the PP Analysis Set.
8.6.2.
Analysis of Secondary Endpoints
Analysis will be performed based on the patient populations on which the endpoints are defined. 
Analysis of EFS will be similar to that of the primary efficacy endpoint OS.
Formal hypothesis testing will be performed to test the statistical hypothesis that the CR + CRh 
rates of the experimental arm and control arm are the same (null hypothesis) versus that the 
experimental arm is superior to the control arm in terms of CR + CRh rate (alternative 
hypothesis).
The Cochran-Mantel-Haenszel test stratified by the randomization stratification factors will be 
used to test whether CR + CRh rates of the 2 arms are the same. The point estimate of the CR + 
CRh rate and the corresponding 2-sided exact 95% CI based on Clopper-Pearson method will be 
provided for each treatment arm.
The CR rate, CR/CRhMRD- rate, CRMRD- rate and transfusion independence conversion rate will 
be evaluated in a similar manner as CR + CRh rate, except that the transfusion independence 
conversion rates will be based on the subset of randomized patients who are transfusion-
dependent at baseline.
For the time-to-event endpoints of DCR and duration of CR + CRh, analysis 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 cycles of treatment. Duration of CR + CRh will be 
based on patients who achieved CR or CRh within 6 cycles of treatment. The Kaplan-Meier 
method will be used to estimate median duration with its 95% CI and Kaplan-Meier plots will be 
provided.
To assess the robustness of the analysis results, key secondary efficacy endpoints will also be 
analyzed in the PP Analysis Set.
8.7.
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 plus 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 by treatment group. 
Details are noted below.
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8.7.1.
Extent of Exposure
A patient’s extent of exposure to study drug data will be generated from the study drug 
administration data. Exposure data will be summarized by treatment group.
8.7.2.
Adverse Events
Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory 
Activities (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 treatment up 
to 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. If the AE onset date is on or before the 
last dose date, the AE is considered as treatment-emergent AE regardless of the start of new 
anticancer therapy. 
Summaries (number and percentage of patients) of treatment-emergent AEs (by system organ 
class and preferred term) will be provided by treatment group.
8.7.3.
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 6.
Incidence of treatment-emergent laboratory abnormalities, 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 drug plus 70 days or the day before initiation of new anticancer therapy including 
SCT, whichever comes first, will be summarized by treatment group. If baseline data are 
missing, any graded abnormality (ie, at least a Grade 1) will be considered treatment emergent.
Laboratory abnormalities that occur before the first dose of study treatment or after the patient 
has been discontinued from treatment for at least 70 days will be included in a data listing.
8.7.4.
Other Safety Evaluations
Vital signs and physical examination findings will be summarized at select time points. Details 
will be provided in the SAP.
8.8.
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.


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Summaiy statistics will be presented for magrolimab sernm concentrntions at each scheduled 
time point. Descriptive graphical plots of individual sernm concentration versus time profiles and 
mean concentration versus time profiles will be generated. 
Missing concentrntion values will be reported as is in data listings. Concentration values below 
lower limit of quantitation will be handled as zero in surnmaiy statistics and repo1i ed 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 repo1ied 
separately. 
Additional analysis such as exposure-response analysis to evaluate the relationship between 
magrolimab exposure and efficacy/safety/PD biomai·kers endpoints in the study may be 
perfo1med if data allows and will be repo1i ed in a sepai·ate report when appropriate. 
8.9. 
Analysis of Patient-Reported Outcome Data 
The key PRO endpoints, TTD on the GHS/QoL scale and TTD on the physical functioning scale 
of the EORTC QLQ-C30, ai·e defined based on the ITT Analysis Set. The TTD will be 
smnmai·ized using the Kaplan-Meier method. The log-rank test stratified by randomization 
stratification factors will be conducted for the TTD compai·ison between treatment anns, and the 
HR estimated using a Cox propo1iional hazai·d regression model stratified by randomization 
stratification factors will be provided. 
Additional analysis will 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 aim. A lineai· mixed effect 
model with treatment, time, tr·eatment by time interaction, str·atification factors, and baseline 
scores as fixed factors may be fitted for analysis of selective PRO endpoints. 
8.10. 
Immunogenicity Analysis 
Immunogenicity will be assessed using a 3-tier (screen, confnmato1y, and titer) approach on 
study sainples using a validated immunoassay. The rate and magnitude of anti-magrolimab 
antibody incidence, prevalence, persistence, and tr·ansience will be sUllllnai·ized for the 
Immune enici Anal sis Set. Titer smnmaries ma also be enerated if relevant. 
Neutr·alizing antibody analysis will be conducted using a validated assay on ADA positive 
sainples and results will be surnmai·ized. 
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The baseline level, absolute level, and change from baseline level over time will be summarized 
using descriptive statistics for each biomarker at the sam le collection time oint b treatment 
aim as a ro riate. 
8.12. 
Sample Size 
The study will randomize approximately 432 patients in total into 2 treatment aims at a 1: 1 ratio, 
dete1mined by fo1mal hypothesis testing perfonned on the primaiy efficacy endpoint: OS, with 
family-wise Type I enor controlled at I-sided significance level of 0.025. 
It is assumed that administration of magrolimab + venetoclax + azacitidine to study patients will 
result in a median OS of approximately 21 months, improved from a median OS of 14.7 months 
in patients treated with placebo + venetoclax + azacitidine. This conesponds to an OS HR of 0. 7. 
Assuming that the dmation of OS is exponentially distributed in each of the 2 aims, with an HR 
equal to 1 under the null hypothesis of no difference between the 2 treatment anns, 303 events 
are needed to detect an HR of 0.7 with 86.4% power at a I-sided significance level of 0.025 
using a log-rank test, the first interim analysis with futility test when 40% of the infonnation 
(121 deaths) is available, and the second interim analysis with superiority test together with a 
futility test when 75% of the info1mation (227 deaths) is available, and one prima1y analysis. For 
the second OS interim analysis and the OS primaiy analysis, the Lan-DeMets alpha spending 
function with O'Brien-Fleming stopping boundaiy will be used. The futility boundai·ies for two 
interim analyses ai·e obtained using a Gamma beta-spending function with pai·ameter -5. 
With an accmal period of 19 months (with approximately 51 % of the patients emolled dming the 
initial 12 months, and the remaining 49% of the patients emolled dming the last 7 months), 
24 months of follow up, and an annual 1.43% dropout rate (5% dropout chance by 43 months 
with time to dropout assuming exponentially distributed time-to-dropout), a total sainple size of 
432 patients (216 patients per treatment group) is needed to obse1ve the required 303 events. 
8.13. 
Data Monitoring Committee 
An external multidisciplinaiy DMC will review the progress of the study, perfonn interim 
reviews of safety data at regular inte1vals, and provide recollllllendation to Gilead whether the 
nature, frequency, and severity of AEs associated with study treatment waiTant the early 
tennination of the study in the best interests of the patient, whether the study should continue as 
planned, or whether the study should continue with modifications. The DMC may also provide 
recommendations as needed regai·ding study design. 
In addition, the DMC will review the results from the interim analyses. Based on the 
pre-specified superiority and futility mles, the DMC may make recommendations to Gilead as to 
whether the study should be te1minated for futility or continue as planned. Efficacy superiority 
boundai·ies ai·e specified in Section 8.2. The nonbinding futility mle with a futility bounda1y of 
HR= 1.1 is used in the first interim analysis, and a futility boundaiy of HR= 0.9 in used in the 
second interim analysis if the null hypothesis of OS fails to be rejected at the second interim 
analysis. 
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The DMC’s specific activities will be defined by a mutually agreed charter, which will define 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. If the DMC recommends stopping the study due to efficacy or futility, a Gilead 
Oversight Committee will be unblinded to confirm the DMC recommendation.


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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 (of Technical Requirements for Pharmaceuticals for Human Use) (ICH) 
E6(R2) addendum to its guideline for Good Clinical Practice 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. As part of 
the study-specific ICF to be signed by each patient participating in the study, patients will be 
asked to document agreement to allow the use of their samples for optional future research, in 
accordance with applicable regulations. In addition to the study-specific ICF to be signed by 
each patient participating in the study, patients will be required to document agreement to use 
already collected samples for optional genomic research. The results of the tests done on the 
samples will not be shared with 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, CRFs/eCRFs, IRB/IEC and 
governmental approval with correspondence, the ICF(s), 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; 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, or Japan) 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
An electronic case report form casebook will be completed by an authorized study personnel 
member whose training for this function is completed in the electronic data capture system 
unless otherwise directed. The electronic case report form casebook will only capture the data 
required per the protocol schedule of events and procedures, unless collected by a nonelectronic 
data capture vendor system (eg, central laboratory). The Inclusion/Exclusion Criteria and 
Enrollment electronic case report forms should be completed only after all data related to 
eligibility are available. Data entry should be performed in accordance with the case report form 


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Completion Guidelines provided by the sponsor. Subsequent to data entry, a study monitor may 
perform source data verification. System-generated or manual queries will be issued in the 
electronic data capture system as data discrepancies are identified by the study monitor or Gilead 
personnel 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. Regular oversight 
by the principal investigator of the data entered into the electronic data capture system is 
expected to occur on an ongoing basis throughout the study to ensure quality and completeness. 
At a minimum, before any interim, final, or other timepoints (as instructed by Gilead), the 
investigator apply his/her electronic signature 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. 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, except those intended to reduce immediate risk to study patients, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Report 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 3.5).


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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.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and the following:
•
The ethical principles of the Declaration of Helsinki
•
International Council for Harmonisation (ICH) Good Clinical Practice (GCP)
•
Applicable laws and regulatory requirements
9.3.2.
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.
9.3.3.
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.
9.3.4.
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.
9.3.5.
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 authorities, 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
Advani R, Flinn I, Popplewell L, Forero A, Bartlett NL, Ghosh N, et al. CD47 Blockade by 
Hu5F9-G4 and Rituximab in Non-Hodgkin's Lymphoma. N Engl J Med 2018;379 
(18):1711-21.
Brahmer J, Lacchetti C, Schneider B, Atkins M, Brassil K, Caterino J, et al. Management of 
Immune-Related Adverse Events in Patients Treated With Immune Checkpoint 
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Guideline. Journal of clinical Oncology 2018;36 (17).
Chao MP, Alizadeh AA, Tang C, Jan M, Weissman-Tsukamoto R, Zhao F, et al. Therapeutic 
antibody targeting of CD47 eliminates human acute lymphoblastic leukemia. 
Cancer Res 2011a;71 (4):1374-84.
Chao MP, Alizadeh AA, Tang C, Myklebust JH, Varghese B, Gill S, et al. Anti-CD47 antibody 
synergizes with rituximab to promote phagocytosis and eradicate non-Hodgkin 
lymphoma. Cell 2010a;142:699-713.
Chao MP, Jaiswal S, Weissman-Tsukamoto R, Alizadeh AA, Gentles AJ, Volkmer J, et al. 
Calreticulin Is the Dominant Pro-Phagocytic Signal on Multiple Human Cancers 
and Is Counterbalanced by CD47. Science translational medicine 2010b;2 
(63):63ra94.
Chao MP, Majeti R, Weissman IL. Programmed cell removal: a new obstacle in the road to 
developing cancer. Nat Rev Cancer. 2012;12 (1):58-67.
Chao MP, Tang C, Pachynski RK, Chin R, Majeti R, Weissman IL. Extranodal dissemination of 
non-Hodgkin lymphoma requires CD47 and is inhibited by anti-CD47 antibody 
therapy. Blood 2011b;118 (18):4890-901.
Chen JY, McKenna KM, Choi TS, Duan J, Brown L, Stewart JJ, et al. RBC-Specific CD47 
Pruning Confers Protection and Underlies the Transient Anemia in Patients 
Treated with Anti-CD47 Antibody 5F9 [Abstract]. Blood (ASH Annual Meeting 
Abstracts) 2018;132 (Suppl 1):2327.
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised 
recommendations of the International Working Group for Diagnosis, 
Standardization of Response Criteria, Treatment Outcomes, and Reporting 
Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 
2003;21 (24):4642-9.
Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, et al. Clinical 
application and proposal for modification of the International Working Group 
(IWG) response criteria in myelodysplasia. Blood 2006;108 (2):419-25.


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Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 
1976;16:31-41.
Department for Health and Human Services (DHHS), Food and Drug Administration (FDA). 
Patient-focused drug development guidance public workshop: methods to identify 
what is important to patients and select, develop or modify fit-for-purpose clinical 
outcomes assessments. Volume 83. Number 156. Available at: 
https://thefederalregister.org/83-FR/Issue-156. Accessed 07 August 2020. Last 
Updated: 13 August.  2018:
DiNardo CD, Jonas BA, Pullarkat V, Thirman MJ, Garcia JS, Wei AH, et al. Azacitidine and 
Venetoclax in Previously Untreated Acute Myeloid Leukemia. N Engl J Med 
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Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, et al. Diagnosis and 
management of AML in adults: 2017 ELN recommendations from an 
international expert panel. Blood 2017;129 (4):424-47.
Edris B, Weiskopf K, Volkmer AK, Volkmer JP, Willingham SB, Contreras-Trujillo H, et al. 
Antibody therapy targeting the CD47 protein is effective in a model of aggressive 
metastatic leiomyosarcoma. Proc Natl Acad Sci U S A 2012;109 (17):6656-61.
EuroQol Research Foundation. EQ-5D-5L: About. Available at: https://euroqol.org/eq-5d-
instruments/eq-5d-5l-about/. Accessed: 10 August 2020. Last Updated: 18 April.  
2017:
Fayers PM. Interpreting quality of life data: population-based reference data for the EORTC 
QLQ-C30. Eur J Cancer 2001;37 (11):1331-4.
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 
[Abstract 2729]. American Society of Hematology Annual Meeting & Exposition; 
2018 December 2; San Diego, CA. 
Fesik SW. Promoting apoptosis as a strategy for cancer drug discovery. Nature reviews. Cancer 
2005;5 (11):876-85.
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.


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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 
2012;26 (12):2538-45.
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.
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.
Sallman D, Asch AS, Kambhampati S, Al Malki M, Zeidner JF, Donnellan W, et al. The First-
in-Class Anti-CD47 Antibody Magrolimab in Combination With Azacitidine is 
Effective in AML Patients: Phase 1b Results [Accepted Abstract]. 62nd American 
Society of Hematology (ASH) Annual Meeting Virtual; 2020a 05-08 December. 
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; 2020b. 
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.
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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U.S. Department of Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (CDER), Center for Biologics 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 
2019;59 (2):730-7.
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.  
2018:
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.
Pandemic Risk Assessment and Mitigation Plan
Appendix 3.
Schedules of Assessment and Treatment Administration
Appendix 4.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements
Appendix 6.
Toxicity Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 7.
Eastern Cooperative Oncology Group Performance Status
Appendix 8.
2017 European LeukemiaNet Risk Stratification by Genetics
Appendix 9.
European Organisation for the Research and Treatment of Cancer Quality of Life 
Questionnaire–Core Questionnaire (EORTC QLQ-C30)
Appendix 10.
EuroQol (5 Dimensions, 5 levels) Questionnaire (EQ-5D-5L)
Appendix 11.
Patient Global Impression of Severity (PGIS) and Patient Global Impression of 
Change (PGIC)
Appendix 12.
Cockcroft Gault Method for Estimating Creatinine Clearance
Appendix 13.
World Health Organization (WHO) Classification of AML (2016)
Appendix 14.
Marketing Authorization Status of Study Interventions
Appendix 15.
Country-Specific Requirements
Appendix 16.
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, Double-Blind, Placebo-Controlled Study Evaluating the Safety and 
Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in 
Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are 
Ineligible for Intensive Chemotherapy
Amendment 7, 20 December 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.
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. Special pandemic measures can be applied only 
when in accordance with the current situation and applicable local authority regulations, 
recommendations, or similar. 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)
Dosing delays with magrolimab/placebo:
(1) For patients who may have travel restrictions, the 4-week period of 
magrolimab/placebo 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.
ii) 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 review and signature. The site is to ensure that all of these documents 
are filed in the patient’s source records.
(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.


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iii) Venetoclax supply to patients:
(1) Patients may be unable to return to the site for a number of visits to get 
venetoclax, or the site may be unable to accept any patient visits.
Mitigation plan: Venetoclax may be provided to the patient from the site without 
a clinic visit, once it is confirmed that the patient may safely continue on 
venetoclax as determined by the principal investigator. 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 venetoclax from sites to study patients if permitted by 
local ethic committee (EC)/institutional review boards (IRB)/Regulatory 
Authority as applicable and with sponsor’s approval.
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) 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 sites:
a) Shipments of study drug could be delayed because of transportation issues. Without study 
drug patients would not be able to stay on the study drug as planned per protocol.
Mitigation plan: The sites’ study drug inventory should be closely monitored. Site staff 
should notify the sponsor or delegate 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.


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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 principal investigator 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, 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);
Mitigation plan: Local laboratories 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.
c) Patients may be unable or unwilling to attend the study visit to sign an updated informed 
consent form (ICF) version.
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 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 trial participants is important and testing of coronavirus disease 2019 
(COVID-19) infection will be based on local clinical guidelines for testing based on 
signs/symptoms and or suspected exposure to COVID-19.


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Mitigation plan: If a 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/venetoclax 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 trial will 
have this event documented as an adverse event in the clinical database.
4) Protocol and monitoring compliance:
a) Protocol deviations may occur, in case 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. In compliance with Gilead policy, a remote SDV 
should not be arranged. 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.
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 trial 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.


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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 magrolimab 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 3.
Schedules of Assessment and Treatment Administration
Appendix Table 1.
Schedule of Assessments for Azacitidine and Venetoclax – Screening and Treatment Period
Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
Informed consentc
X
Demographics
X
Medical and cancer 
history, AML molecular 
marker results at diagnosis 
(if available), including 
date of most recent RBC 
and/or platelet 
transfusion(s)
X
Physical examinationd,e
X
X
X
X
X
X
HBV, HCV, and HIV
X
Vital signs, height, and 
weighte,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Pregnancy teste,g
X
Q4W
CBC with differential, 
platelets, reticulocytes, 
blastse,h
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHe 
X
X
X
X
X
Serum or plasma 
chemistrye
X
Xi
Xi
Xi
Xi
X
X
X
X
X
X
~ 
~ 


Magrolimab
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Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
PT/INR, and aPTT (or 
PTT)
X
Blood phenotyping or 
genotyping, type, and 
screen (ABO/Rh), DATj
X
Urinalysis
X
ECOG performance status
X
12 Lead ECG (single)
X
Echocardiogram or 
MUGAk
X
Pulmonary function testsl
X
Adverse eventsm
Concomitant medicationsn
Eligibility criteria
X
Randomizationc
X
Efficacy/Biomarkers
PRO assessmento
X
X
X
Peripheral blood smear (for 
blasts)p
X
X
X
C4D28, 
C6D28,
then 
Q3C


Magrolimab
Protocol GS-US-590-6154
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 132
15 December 2023
Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
Peripheral blood sample 
for biomarker studiesq
X
X
X
Xr
X
Xr
C3D28, 
C6D28, 
C12D28
Bone marrow aspirate for 
biomarker studiess
X
X
X
C6D28, 
C12D28
Bone marrow biopsy for 
biomarker studies
X
X
C12D28
Bone marrow aspirate for 
response assessment and 
cytogeneticss,t
X
X
X
C4D28, 
C6D28,
then 
Q3C
Bone marrow aspirate for 
flow based MRD 
assessmentt
X
X
X
C4D28, 
C6D28
Bone marrow aspirate ± 
biopsy slides or blocksu for 
independent central 
reviews
X
X
X
C4D28, 
C6D28,
then 
Q3C
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; ADA = antidrug antibodies; AE = adverse event; AML = acute myeloid leukemia; 
aPTT = activated partial thromboplastin time; CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology 
Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EOT= end of treatment; EQ-5D = EuroQoL 
(5 dimensions, 5 levels); HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; INR = international normalized ratio; LDH = lactate 
dehydrogenase; MRD = minimal residual disease; PGIS/PGIC = Patient Global Impression of Severity/Patient Global Impression of Change; PRO = patient-reported outcome; 
PT = prothrombin time; PTT = partial thromboplastin time; Q3C = every 3 cycles; RBC = red blood cell; Rh = Rhesus factor; SAE = serious adverse event; WBC = white blood 
cell


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Gilead Sciences, Inc.
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a
Any other visit window specifications for individual assessments should be applied.
b
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.
c
Screening must be completed prior to 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.
d
Complete physical examination is to be performed at screening and symptom-directed physical examination is to be performed from Cycle 1 Day 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 study treatment administration. 
f
Vital signs will be assessed prior to administration of any study treatment. Details are provided in Section 6.6.4. Height will be collected at screening only. Weight will be 
collected at screening and Day 1 of each cycle.
g
A serum pregnancy test will be conducted at screening and serum or urine pregnancy tests will be conducted every 4 weeks thereafter and can be performed locally without a 
requirement to visit the study site. A follicle-stimulating hormone 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. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the 
screening pregnancy test was performed within the 72 hours before study treatment administration. Additional guidance is provided in Section 6.6.1.
h
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/placebo dose 
during Cycle 1.
i
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. An additional blood chemistry is to be collected 24 hours (±3 hours) after the Cycle 1 Day 3 administration.
j
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 participant. Red blood cell genotyping instead of extended RBC phenotyping is acceptable for any patient. Red blood cell genotyping (instead of an extended RBC 
phenotyping) must be performed if a participant received any RBC or whole blood transfusion within the previous 3 months (unless the laboratory has availability for special 
techniques for performing phenotyping for participants with a recent transfusion). Results must be available before the first dose of magrolimab.
k
Only for patients ≥ 18 to 74 years of age with cardiac disease, if needed to determine ineligibility to intensive chemotherapy
l
Only for patients ≥ 18 to 74 years of age with pulmonary disease, if needed to determine ineligibility to intensive chemotherapy
m
All SAEs and any AEs related to protocol-mandated procedures should be collected at screening. Adverse events should be recorded at all scheduled and unscheduled 
assessment visits, and at all treatment visits, even when other assessments are not scheduled.
n
Prior and concomitant medications should be collected at screening. Concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at 
all treatment visits, even when other assessments are not scheduled.
o
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. If the PRO instruments are not available in a patient’s language, patients are not required to complete the assessments. Patients with other situations 
related to PRO instrument completion (eg, visual impairment/blindness, limitation in upper extremity mobility/dexterity) may be exempt from these assessments after 
discussion with the sponsor.
p
Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy.
q
Samples will be collected predose within 12 hours prior to study treatment administration.
r
Starting at Cycle 2 Day 1, peripheral blood samples for biomarker studies on Cycle X Day 1 do not need to be repeated at Day 1 of the cycle if they have been collected 
within the past 7 days.
s
A trephine (biopsy) is to be collected if the aspirate sample is dry (not obtainable). If a bone marrow aspirate sample is not evaluable, another aspirate sample must be performed 
within 7 days. At screening, this procedure must be performed prior to the first dose of study treatment at the latest. An aspirate sample will be collected for response assessment 
(eg, blast evaluation), cytogenetics, MRD assessment (performed during the first 6 cycles only), biomarker studies, and biobanking. When done on the same day, bone marrow 
aspirate samples are to be obtained at the time of bone marrow (trephine) biopsy. Conventional cytogenetics are to be tested per institutional standards. 


Magrolimab
Protocol GS-US-590-6154
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 134
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t
Response assessments may be adjusted by ± 1 week for Day 28 of Cycles 1 and 2. After Cycle 2 Day 28, the window is ± 14 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.
u
Bone marrow biopsy (blocks) collected within 1 month prior to the signing of informed consent may be used in lieu of bone marrow biopsy at screening.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 7
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Appendix Table 2.
Schedule of Treatment Administration for Azacitidine and Venetoclax
Cycle (28-day Cycles)
1b
2b
3+b
Cycle Daya
1
2
3
4
5
6
7
8
11
15
22
1
2
3
4
5
6
7
8
15
22
1
2
3
4
5
6
7
Azacitidinec
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Venetoclaxd
Daily Days 1-28
Daily Days 1-28
Daily Days 1-28
a
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.
b
Visit window: Cycle 1 Days 3-15, ± 3 days; Cycle 2 onward, ± 3 days.
c
Azacitidine administration should be completed at least 1 hour before magrolimab/placebo administration on days when both drugs are administered. Azacitidine may be 
administered on an alternative schedule of Days 1 to 5, Day 8, and Day 9 of a 28-day cycle for flexibility and convenience. Please refer to Table 6. Once the patient has 
completed the first cycle of treatment, azacitidine may be administered at home only on days where magrolimab/placebo is not given and azacitidine is administered alone. 
Study drug should not be held for bone marrow biopsy.
d
Venetoclax is administered daily. Please refer to Table 6. Study drug should not be held for bone marrow biopsy.


Magrolimab
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Final
Gilead Sciences, Inc.
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Appendix Table 3.
Magrolimab/Placebo Administration and Associated Assessment Schedule-Treatment Period
Visit Window (Days)
Nonea
± 3a
Weekly x 5 ± 3 days
Every 2 weeks ± 3 daysb
Day
1 
4 
8
11
15
Vital signsc
X
X
X
X
X
X
X
CBC (hemoglobin)d
pre and postdose
pre and postdose
X
X
X
PKe
Within 12 hours 
prior to 
magrolimab/placebo 
dosing
Antidrug antibodiesf
Within 72 hours 
prior to 
magrolimab/placebo 
dosing
Within 12 hours 
prior to 
magrolimab/placebo 
dosing
Within 12 hours 
prior to 
magrolimab/placebo 
dosing for 2nd week 
dose
Within 12 hours prior to 
magrolimab/placebo 
dosing before 1st, 5th, 
9th, 15th and 21st 
biweekly maintenance 
doses of 30 mg/kgf
Magrolimab/Placebo Administration
Premedicationg
X
X
X
X
Magrolimab/Placeboh
X
X
X
X
X
X
X
ADA = antidrug antibodies; CBC = complete blood count; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin concentration; MCV = mean 
corpuscular volume; PK = pharmacokinetic(s); RDW = red blood cell distribution width; 
a
In cases of magrolimab/placebo repriming/re-escalation following a treatment delay (Section 5.5.1.1), follow magrolimab/placebo schedule of assessment and administration 
for repriming (Appendix Table 4). 
b
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/placebo.
c
Vital signs will be assessed prior to administration of magrolimab/placebo. Details are provided in Section 6.6.4.
d
Hemoglobin must be checked 3 to 6 hours after the initiation of the first and second doses of magrolimab/placebo during initial treatment, as described in Section 5.5.3.1. For 
CBC collection schedule beyond Day 15, please refer to Appendix Table 1.
e
Samples will be collected predose within 12 hours prior to administration of magrolimab/placebo.
f
When collected on the day of study treatment dosing, the blood sample for ADA must be collected at the same time as the PK sample.
g
Premedication for magrolimab/placebo is required prior to the administration of the first 4 doses of study treatment and 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 cycles is required (Section 5.5.1.2).
h
Magrolimab/placebo doses should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab/placebo, 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/placebo dosing, please refer to Table 6.


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Gilead Sciences, Inc.
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Appendix Table 4.
Magrolimab/Placebo Repriming Administration and Associated Assessment Schedule – Treatment 
Period
Visit Window (Days)a
None
± 3
Day
1
2
4
8
11
15
22b
29, then every 
2 weeks
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
Vital signse
X
X
X
X
X
X
X
Weight
X
Symptom-directed 
physical 
examinationc
X
X
X
Adverse eventsf
Concomitant 
medicationsf
PK/ Immunogenicity
PKg
X
X
Xg
Xg
Antidrug 
antibodiesh
X
Xh
Xh
Magrolimab/Placebo Administration
Premedicationi
X
X
X
X
Magrolimab/Placeboj
X
X
X
X
X
X
Xj
CBC = complete blood count; 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/placebo treatment, patient should receive magrolimab 30 mg/kg or placebo weekly x 5 after receiving Day 15 dose. 
All Day 22 safety assessments should be completed weekly x 5. One week after the fifth weekly dose, dosing of magrolimab/placebo 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; thereafter, pretreatment assessments are to be 
collected within 24 hours prior to any study treatment administration.
~ 
~ 
-
~ 


Magrolimab
Protocol GS-US-590-6154
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
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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/placebo dose during 
first 4 weeks of repriming.
e
Vital signs will be assessed prior to administration of magrolimab/placebo. Details are provided in Section 6.6.4.
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.
g
Samples will be collected within 72 hours before the first dose of magrolimab/placebo and within 12 hours before subsequent doses of magrolimab/placebo. In addition to 
Day 1, Day 8, and Day 15, 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 first, fifth, ninth, 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/placebo.
h
When collected on the day of magrolimab/placebo 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, Day 15, and Day 29 (only applicable if the repriming schedule has 4 additional weekly doses post Day 22), as well as before the first, fifth, 
ninth, 15th, and 21st biweekly maintenance doses of 30 mg/kg, respectively, and at EOT.
i
Premedication for magrolimab/placebo 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 cycles is required (Section 5.5.4 and Section 5.5.3.2.1).
j
Magrolimab/placebo doses should not be given on consecutive days. The duration of infusion will be 3 hours (± 30 minutes) for the first 3 doses of magrolimab/placebo, 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/placebo 
dosing, please refer to Table 6.


Magrolimab
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Final
Gilead Sciences, Inc.
Amendment 7
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15 December 2023
Appendix Figure 1. Posttreatment Visit Schedule
AML = acute myeloid leukemia; EOT = end of treatment; FU = follow-up; SCT = stem cell transplant 
Screening
Randomization 
1:1
Magrolimab+Venetoclax+Azacitidine
N=216
Placebo+Venetoclax+Azacitidine
N=216
30-day window
Screen 
Visit
Day 1
Visit
End of Treatment
Start of new anti-
AML therapy 
(except SCT)
Stem Cell 
Transplant (SCT)
Disease Progression, 
relapse or other 
reasons than start of 
new anti-AML 
treatment (exc. SCT)
OT Visit
OT Visit
EOT Visit
Overall Survival 
Every 2 months phone calls up to 5 years from EOT visits
Long Term Follow Up
Every 12 weeks visits from date of SCT
Long Term Follow Up
Every 12 weeks visits after last does of study treatment 
Start of new anti-AML 
therapy (exc.post SCT 
maintenance) 
30-day 
Safety FU
30-day 
Safety FU
70-day 
Safety FU
70-day 
Safety FU
Screening
Randomization 
1:1
Magrolimab+Venetoclax+Azacitidine
N=216
Placebo+Venetoclax+Azacitidine
N=216
30-day window
Screen 
Visit
Day 1
Visit
End of Treatment
Start of new anti-
AML therapy 
(except SCT)
Stem Cell 
Transplant (SCT)
Disease Progression, 
relapse or other 
reasons than start of 
new anti-AML 
treatment (exc. SCT)
OT Visit
OT Visit
EOT Visit
Overall Survival 
Every 2 months phone calls up to 5 years from EOT visits
Long Term Follow Up
Every 12 weeks visits from date of SCT
Long Term Follow Up
Every 12 weeks visits after last does of study treatment 
Start of new anti-AML 
therapy (exc.post SCT 
maintenance) 
30-day 
Safety FU
30-day 
Safety FU
70-day 
Safety FU
70-day 
Safety FU
I 
D-
D 
-
l 
DD 
D-
I 
D-
D 
-
l 
DD 
D-


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Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 140
15 December 2023
Appendix Table 5.
Schedule of Assessments – Posttreatment
End-of-
Treatment Visit
Safety Follow-up 
Visit/Telephone 
Calla
Safety Follow-up 
Visit/Telephone 
Calla
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 Dose
Until Start of a 
New Anti-AML 
Therapyb
Until Start of a 
New Anti-AML 
Therapyb
Every 2 Months 
(up to 5 years 
from EOT visit) 
Until Death or 
End of Study, 
whichever occurs 
first
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 days
± 14 days
—
Symptom-directed physical 
examination
X
Vital signs 
X
Serum or urine pregnancy testc
Q4W
CBC with differential, platelets, 
reticulocytes, blasts
X
Q12W
Q12W
Serum or plasma chemistry
X
ECOG performance status
X
Adverse eventsd
X
X
X
Concomitant medications
X
X
X
New anti-AML therapy reportinge
X
X
X
X
X
X
PRO assessmentf
X
Q12W
Q12W
Peripheral blood smear (for blasts)
X
Q12W
Q12W
Peripheral blood sample for 
biomarker studies
X
Bone marrow aspirate for biomarker 
studies
X


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Final
Gilead Sciences, Inc.
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End-of-
Treatment Visit
Safety Follow-up 
Visit/Telephone 
Calla
Safety Follow-up 
Visit/Telephone 
Calla
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 Dose
Until Start of a 
New Anti-AML 
Therapyb
Until Start of a 
New Anti-AML 
Therapyb
Every 2 Months 
(up to 5 years 
from EOT visit) 
Until Death or 
End of Study, 
whichever occurs 
first
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 days
± 14 days
—
Bone marrow aspirate for response 
assessment, and cytogeneticsg,h
X
Q12W
Q12W
Pharmacokinetics
X
Antidrug antibodies 
X
Survival follow-up
X
AE = adverse event; CBC = complete blood count; ECOG = Eastern Cooperative Oncology Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of 
Cancer Quality of Life Questionnaire; EOT = end of treatment; EQ-5D = EuroQoL (5 dimensions, 5 levels); PGIS/PGIC = Patient Global Impression of Severity/Patient Global 
Impression of Change; PRO = patient-reported outcome; Q4W = every 4 weeks; Q12W = every 12 weeks; SAE = serious adverse event; SCT = stem cell transplant
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 start new anti-AML therapy (other than SCT) before a relapse, efficacy status (done as standard of care) will be collected until relapse.
c
Pregnancy testing will be continued monthly up to 6 months after the end of treatment per the duration of contraception requirement as discussed in Appendix 5. Testing 
during survival follow-up may be done at home and the result self-reported by the patient.
d
Report all AEs through the Safety Follow-up Visit/Call, and any treatment-related SAEs thereafter.
e
Collect data for the first new anti-AML therapy following the last dose of study treatment or following SCT.
f
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. If the PRO 
instruments are not available in a patient’s language, patients are not required to complete the assessments. Patients with other situations related to PRO instrument 
completion (eg, visual impairment/blindness, limitation in upper extremity mobility/dexterity) may be exempt from these assessments after discussion with the sponsor.
g
Response assessment at EOT visit not required if performed within the last 30 days or documented disease progression/relapse or start of new anti-AML therapy, whichever 
occurs first. (SCT and maintenance therapy are not considered new anti-AML therapy.) 
h
Conventional cytogenetic testing (per institutional standards) is required for all patients.


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Final
Gilead Sciences, Inc.
Amendment 7
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Appendix 4.
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 European 
LeukemiaNet (ELN) 2017 recommendations for AML with modifications {Dohner 2017} 
(Appendix Table 6). 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).
Cytogenetic CR (cCR) will be assessed by 2003 IWG criteria as CR with normal cytogenetics 
(Appendix Table 7) {Cheson 2003}.
Hematologic improvement will be assessed by 2006 IWG criteria {Cheson 2006} to compare 
with disease response assessed by 2017 ELN criteria (Appendix Table 8) {Dohner 2017}.
The date of the bone marrow assessment should be used as the date of response assessment. 
Complete blood count 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 or both, other than bone 
marrow blast assessments, then the date of the corresponding CBC or new extramedullary 
disease assessment or the earlier of these 2 dates will be used as the date of response assessment.


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Appendix Table 6.
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%
MRD negative (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%). Absence of 
circulating blasts and blasts with 
Auer rods; absence of extramedullary 
disease. 
Complete 
remission with 
positive or 
unknown minimal 
residual disease 
(CRMRD+/unk)
> 1.0  109/L
> 100  109/L
< 5%
MRD positive (determined using 
multiparameter flow cytometry with 
a sensitivity of < 0.1%) or unknown. 
Absence of circulating blasts and 
blasts with Auer rods; absence of 
extramedullary disease. 
Complete 
remission with 
incomplete 
hematologic 
recovery (CRi)a
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. (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 
Stable disease
Absence of CRMRD-, CRMRD+/unk, CRi, CRh, PR, MLFS; and criteria for progressive disease 
not met 


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Definitions
Response 
Criteria
Neutrophils
Platelets
Bone Marrow 
Blasts
Other
Progressive 
disease 
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% increase is required in 
cases with < 30% blasts at baseline); or persistent marrow blast percentage of > 70% 
over at least 3 months, and 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  % 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
ANC = absolute neutrophil count; CRh = complete remission with partial hematologic recovery; CRi = complete remission with 
incomplete hematologic recovery; CRMRD− = complete remission without minimal residual disease; CRMRD+/unk = complete 
remission with positive or unknown minimal residual disease; ELN = European LeukemiaNet; MLFS = morphologic leukemia-
free state; MRD = minimal residual disease; PR = partial remission; WBC = white blood cell 
a
A response could be classified as both CRh and CRi if both criteria are met.
Source: Based on ELN 2017 guidelines {Dohner 2017} with modifications for the purposes of this protocol.
Appendix Table 7.
Additional Response Definitions Used in This Study (2003 IWG 
Criteria)
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Cytogenetic CR 
(cCR)
> 1.0  10
9/L
> 100  10
9/L
< 5%
Cytogenetics 
normal and no 
evidence of 
extramedullary 
disease
Treatment Failurea
Failure to achieve CR within 6 cycles of treatment 
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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Appendix Table 8.
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 Hematological 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 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Definitions
a. Definition of Childbearing Potential
Magrolimab is contraindicated in pregnancy as a higher incidence of total pregnancy loss has 
been observed in an embryo-fetal development toxicity study in cynomolgus monkeys and there 
is a strong suspicion of human fetotoxicity in early pregnancy based on the nonclinical data. For 
magrolimab, there is no anticipated PK interaction with progestin or other steroids based on the 
distinct clearance pathways. 
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 < 54 years of 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 Patients
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 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.


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Based on the mechanism of action (MOA) and findings in animals, azacitidine may cause fetal 
harm when administered to a pregnant woman. Advise females with reproductive potential to 
avoid pregnancy during treatment with azacitidine. Studies in vitro have demonstrated that CYP 
enzyme induction or inhibition by azacitidine at clinically achievable plasma concentrations is 
unlikely.
Based on its MOA and findings in animals, venetoclax may cause embryo-fetal harm when 
administered to a pregnant woman. Advise females with reproductive potential to avoid 
pregnancy during treatment with venetoclax. It is currently unknown whether venetoclax may 
reduce the effectiveness of hormonal contraceptives.
Refer to the latest version of the magrolimab IB for additional information. Refer to the regional 
prescribing information for additional information on the potential risks of treatment with 
azacitidine, and venetoclax.
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 every 4 weeks thereafter 
until the end of contraception requirement. Duration of required contraception for female 
patients in this clinical trial should start from screening visit until 6 months after the last dose of 
study drug administered. 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 patient’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)
•
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:


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•
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.
3) Contraception Requirements for Male Patients
Male patients with female partners of childbearing potential must use condoms during treatment 
and until 3 months (6 months in Canada only) after the last dose of study drug administered. 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.


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4) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, postovulation 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
Female patients will be instructed to notify the investigator 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.
Male patients whose partner has become pregnant or suspects she is pregnant from start of study 
to 3 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.
Toxicity Grading Scale for Severity of Adverse Events and 
Laboratory Abnormalities
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_
Reference_8.5x11.pdf


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Appendix 7.
Eastern Cooperative Oncology Group 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 8.
2017 European LeukemiaNet Risk Stratification by Genetics
Risk Categorya
Genetic Abnormality
t(8;21)(q22;q22.1); RUNX1-RUNX1T1
inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Mutated NPM1 without FLT3-ITD or with FLT3-ITDlow,b
Favorable
Biallelic mutated CEBPA
Mutated NPM1 and FLT3-ITDhigh,b
Wild-type NPM1 without FLT3-ITD or with FLT3-ITDlow,b (without adverse-risk 
genetic lesions)
t(9;11)(p21.3;q23.3); MLLT3-KMT2Ac
Intermediate
Cytogenetic abnormalities are not classified as favorable or adverse
t(6;9)(p23;q34.1); DEK-NUP214
t(v;11q23.3); KM2A rearranged
t(9;22)(q34.1;q11.2); BCR-ABL1
inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2); GATA2,MECOM(EV11)
−5 or del(5q); −7; −17/abn(17p)
Complex karyotyped, monosomal karyotypee
Wild-type NPM1 and FLT3-ITDhigh,b
Mutated RUNX1f
Mutated ASXL1f
Adverse
Mutated TP53g
AML = acute myeloid leukemia; DNA = deoxyribonucleic acid; HCT = hematopoietic cell transplant; WHO = World Health 
Organization
a
Prognostic impact of a marker is treatment-dependent and may change with new therapies.
b
Low, low allelic ratio (< 0.5); high, high allelic ratio (≥ 0.5); semiquantitative assessment of FLT3-ITD allelic ratio (using 
DNA fragment analysis) is determined as ratio of the area under the curve “FLT3-ITD” divided by area under the curve 
“FLT3-wild-type”; recent studies indicate that AML with NPM1 mutation and FLT3-ITD low allelic ratio may have a more 
favorable prognosis and patients should not routinely be assigned to allogeneic HCT. 
c
The presence of t(9;11)(p21.3;q23.3) takes precedence over rare, concurrent adverse-risk gene mutations.
d
Three or more unrelated chromosome abnormalities in the absence of 1 of the WHO-designated recurring translocations or 
inversions, that is, t(8;21), inv(16) or t(16;16), t(9;11), t(v;11)(v;q23.3), t(6;9), inv(3) or t(3;3); AML with BCR-ABL1.
e
Defined by the presence of 1 single monosomy (excluding loss of X or Y) in association with at least 1 additional 
monosomy or structural chromosome abnormality (excluding core-binding factor AML).
f
These markers should not be used as an adverse prognostic marker if they co-occur with favorable-risk AML subtypes.
g
TP53 mutations are significantly associated with AML with complex and monosomal karyotype.
Frequencies, response rates, and outcome measures should be reported by risk category, and, if sufficient numbers are available, 
by specific genetic lesions indicated. 
Table adapted from {Dohner 2017}.


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Appendix 9.
European Organisation for the Research and Treatment of Cancer 
Quality of Life Questionnaire–Core Questionnaire (EORTC 
QLQ-C30)
ENGLISH 
EORTC QLQ-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 constipated? 
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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ENGIJSH 
During the past week: 
Not at 
A 
Quite 
Very 
All 
little 
a Bit 
Much 
17. Have you had diarrhe.a? 
2 
3 
4 
18. Were you tired? 
2 
3 
4 
19. Did pain interfere with your daily activities? 
2 
3 
4 
20. Have you had difficulty in concentrating on things, 
like rnading a newspaper or watching television? 
4 
21. Did you feel ten,e? 
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 physical condition or medical treatmen 
interfered with your family life? 
2 
3 
4 
27. Has your physical condition or medic 
interfered with your social activities? 
2 
3 
4 
28. Has your physical condi • 
caused you financial di 
2 
3 
4 
For the followin., 
best applies to 
·cle the number between 1 and 7 that 
29. 
4 
5 
6 
7 
2 
3 
4 
5 
6 
7 
Very poor 
Excellent 
© Cop)'right 1~95 EORTC Quality ofLlfe Group. All 1ights n,sem,d. Version 3.0 


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Appendix 10.
EuroQol (5 Dimensions, 5 levels) Questionnaire (EQ-5D-5L)
Health Questionnaire 
English version for the USA 
© 2009 EuroQol Research Foundation. EQ-5O™ 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 I 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-5O™ 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. 
YOUR HEAL TH TODAY = 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 11.
Patient Global Impression of Severity (PGIS) and Patient Global 
Impression of Change (PGIC)
HEALTH-RELATED QUALITY OF LIFE
Patient Global Impression Status: health-related quality of life
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
Patient Global Impression of Change: health-related quality of life
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
Patient Global Impression of Status: physical function
Please choose the response below that best describes your physical function*
•
Excellent
•
Good
•
Moderate
•
Poor
•
Very Poor
* Physical function includes activities like eating, dressing, washing yourself, or using the toilet, 
carrying a heavy shopping bag or a suitcase, taking a long walk, taking a short walk outside of 
the house, and not having to stay in bed or chair during the day.
Patient Global Impression of Change: physical function
All things considered, how did your physical function change since you started taking the study 
medication?*
•
Much improved
•
A little improved
•
No change
•
A little worsened
•
Much worsened 
* Physical function includes activities like eating, dressing, washing yourself, or using the toilet, 
carrying a heavy shopping bag or a suitcase, taking a long walk, taking a short walk outside of 
the house, and not having to stay in bed or chair during the day.


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Appendix 12.
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 
patient’s gender should be used.
Serum 
Creatinine 
Units
Gender
Formula
(140-patient age [years])  patient weight [kilograms]  1
72  patient serum creatinine [mg/dl]
(140- patient age [years])  patient weight [kilograms]  0.85
mg/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
72  patient serum creatinine [mg/dl]
(140- patient age [years])  patient weight [kilograms]  1.23
Patient serum creatinine [mg/dl]
(140- patient age [years])  patient weight [kilograms]  1.04
M/dL
Males
Females
     eCcr              =
[mL/min]
     eCcr              =
[mL/min]
Patient serum creatinine [mg/dl]
Abbreviation: eCcr=estimated creatinine clearance
Source: {Cockcroft 1976}


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Appendix 13.
World Health Organization (WHO) Classification of AML (2016)
AML with recurrent genetic abnormalities 
•
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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Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
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15 December 2023
Appendix 14.
Marketing Authorization Status of Study Interventions
Study 
Intervention 
Name
Category
Authorized in 
≥ 1 Country 
Following EU 
Regulation 
No. 536/2014
Authorized 
in ≥ 1 ICH 
Country
Authorized by 
Swissmedic
Magrolimab 
Study drug 
No 
Noa
No 
Azacitidine 
Study drug 
Yes 
Yesa
Yes 
Venetoclax 
Study drug 
Yes 
Yesa
Yes 
Acetaminophen 
AxMP 
Yes 
Yes 
Yes 
Diphenhydramine 
AxMP 
Yes 
Yes 
Yes 
Dexamethasone
AxMP 
Yes 
Yes 
Yes 
AxMP = auxiliary medicinal product; EU = European Union; ICH = International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use 
a
Rationale described in Section 1.


Magrolimab 
Protocol GS-US-590-6154 
Final 
Gilead Sciences, Inc. 
Amendment 7 
Appendix 15. 
Country-Specific Requirements 
Additional Country-Specific Requirements for France 
Country-specific Requirements 
F#l2: Patients must be willing to consent to mandatory pretreatment and on-treatment bone 
man-ow assessments. 
Bone man-ow aspirate for blast evaluation (response assessment), cytogenetics, MRD 
assessment, and biomarker studies. A trephine (biopsy) is required if the aspirate sample is dry 
(not obtainable). 
Bone man-ow assessments ( aspirate and/trephine biopsy if the aspirate sample is dry [ not 
obtainable]) are required for response assessments ( eg, blast evaluation), including 
conventional cytogenetic analysis per institutional standards (Appendix Table 1). In addition, 
bone man·ow specimens may be used for biomarker studies, MRD monitoring, -
-
• and biobanking. Bone man-ow biopsy for biomarker studies will be optional. 
Minimal residual disease testing and biomarker studies will be performed by a central 
laboratory. Details for preparation and distribution of aspirate and/or biopsy/trephine 
specimens to the testing laboratories will be provided in the laboratory manual for this study. 
Bone man-ow aspirate and/or biopsy slides or blocks for efficacy assessments will be prepared 
for potential evaluation of response assessments by independent central review. 
Peripheral blood, bone man·ow aspirate, and trephine biopsy samples will be collected from all 
patients who have provided consent to participate in this study. Bone marTow trephine biopsy 
for biomarker studies ar·e optional. However, for patients whose bone man·ow aspirate is dry 
(not obtainable), trephine biopsy samples will be required for biomarker studies. On-treatment 
Bromar er samp es may e use to eva uate t e association of 
systermc an or tissue- ase 
iomarkers with study drug response, including efficacy and/or 
AEs, dose optimization, and to better understand the biology of AML in general. Because 
biomar·ker 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 
biomar·kers and assays described below. The testing outlined below is based upon the cun-ent 
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. 
CONFIDENTIAL 
Page 163 
Protocol 
Section 
Section 4.2 
Section 6.2.1 
Section 6.5.1 
Section 6.9 
15 December 2023 


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Gilead Sciences, Inc.
Amendment 7
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Appendix Table 1.
Schedule of Assessments for Azacitidine and Venetoclax – Screening and Treatment Period
Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
Informed consentc
X
Demographics
X
Medical and cancer 
history, AML molecular 
marker results at diagnosis 
(if available), including 
date of most recent RBC 
and/or platelet 
transfusion(s)
X
Physical examinationd,e
X
X
X
X
X
X
HBV, HCV, and HIV
X
Vital signs, height, and 
weighte,f
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Pregnancy teste,g
X
Q4W
CBC with differential, 
platelets, reticulocytes, 
blastse,h
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHe 
X
X
X
X
X
Serum or plasma 
chemistrye
X
Xi
Xi
Xi
Xi
X
X
X
X
X
X
PT/INR, and aPTT (or 
PTT)
X
~ 
~ 


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Gilead Sciences, Inc.
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15 December 2023
Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
Blood phenotyping or 
genotyping, type, and 
screen (ABO/Rh), DATj
X
Urinalysis
X
ECOG performance status
X
12 Lead ECG (single)
X
Echocardiogram or 
MUGAk
X
Pulmonary function testsl
X
Adverse eventsm
Concomitant medicationsn
Eligibility criteria
X
Randomizationc
X
Efficacy/Biomarkers
PRO assessmento
X
X
X
Peripheral blood smear (for 
blasts)p
X
X
X
C4D28, 
C6D28,
then 
Q3C
Peripheral blood sample 
for biomarker studiesq
X
X
X
Xr
X
Xr
C3D28, 
C6D28, 
C12D28


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Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
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15 December 2023
Visit Window (Days)a
Screen-
ing
Cycle (28-day Cycles)
1
2
3+
None
± 3
± 3
± 3
Cycle Day
-30 to
-1
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until Count 
Recovery 
(Max = 
14 Days)b
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)b
1
15
28
Twice 
Weekly Until 
Count 
Recovery 
(Max = 
14 Days)b
Bone marrow aspirate for 
biomarker studiess
X
X
X
C6D28, 
C12D28
Bone marrow aspirate for 
response assessment and 
cytogeneticss,t
X
X
X
C4D28, 
C6D28,
then 
Q3C
Bone marrow aspirate for 
flow based MRD 
assessmentt
X
X
X
C4D28, 
C6D28
Bone marrow aspirate ± 
biopsy slides or blocksu for 
independent central 
reviews
X
X
X
C4D28, 
C6D28,
then 
Q3C
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; ADA = antidrug antibodies; AE = adverse event; AML = acute myeloid leukemia; 
aPTT = activated partial thromboplastin time; CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology 
Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EOT= end of treatment; EQ-5D = EuroQoL 
(5 dimensions, 5 levels); HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; INR = international normalized ratio; LDH = lactate 
dehydrogenase; MRD = minimal residual disease; PGIS/PGIC = Patient Global Impression of Severity/Patient Global Impression of Change; PRO = patient-reported outcome; 
PT = prothrombin time; PTT = partial thromboplastin time; Q3C = every 3 cycles; RBC = red blood cell; Rh = Rhesus factor; SAE = serious adverse event; WBC = white blood 
cell
a
Any other visit window specifications for individual assessments should be applied.
b
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.
CCI


Magrolimab 
Protocol GS-US-590-6154 
Gilead Sciences, Inc. 
Final 
Amendment 7 
c 
Screening must be completed prior to randomization. Randomization must occtu· within 30 days of signing info,med consent. The first dose of study treatment must be given 
within 72 hotu·s after randomization. 
d 
Complete physical examination is to be pe1fo1med at screening and symptom-directed physical examination is to be pe,fonued from Cycle 1 Day 1. 
e 
Pretreatment assessments for the initial dose (Cycle 1 Day 1) may be collected up to 72 hotu-s before administration of any study treatment; thereafter, pretreatment 
assessments are to be collected within 24 hours prior to any study treatment administration. 
f 
Vital signs will be assessed prior to administration of any study treatment. Details are provided in Section 6.6.4. Height will be collected at screening only. Weight will be 
collected at screening and Day 1 of each cycle. 
g 
A senuu pregnancy test will be conducted at screening and senuu or tu-ine pregnancy tests will be conducted eve,y 4 weeks thereafter and can be pe1fo1med locally without a 
requirement to visit the study site. A follicle-stimulating hormone test is required for female patients who are < 54 years old who are not on ho,monal contraception and who 
have stopped menstruating for:;:: 12 months but do not have doctuuentation of ovarian honuonal failure. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the 
screening pregnancy test was pe1fo1med within the 72 hotu·s before study treatment administration. Additional guidance is provided in Section 6.6.1. 
h 
Additional samples for CBC may be collected outside of the protocol-specified time points to enstu·e a WBC level~ 20 x 103/µL prior to each magrolimab/placebo dose 
dtu-ing Cycle 1. 
To monitor the risk of ttuuor lysis syndrome dtu-ing venetoclax ramp-up, blood cheinistry 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. An additional blood cheinistry is to be collected 24 hours (±3 hours) after the Cycle 1 Day 3 administration. 
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 participant. Red blood cell genotyping instead of extended RBC phenotyping is acceptable for any patient. Red blood cell genotyping (instead of an extended RBC 
phenotyping) must be performed if a pa,ticipant received any RBC or whole blood transfusion with.in the previous 3 months (unless the laboratory has availability for special 
techniques for pe1fo1ming phenotyping for participants with a recent transfusion). Results must be available before the first dose of magrolimab. 
k 
Only for patients:;:: 18 to 74 years of age with cardiac disease, if needed to detennine ineligibility to intensive chemotherapy 
1 
Only for patients:;:: 18 to 74 years of age with pulmonary disease, if needed to detennine ineligibility to intensive chemotherapy 
m 
All SAEs and any AEs related to protocol-mandated procedtu·es should be collected at screening. Adverse events should be recorded at all scheduled and unscheduled 
assessment visits, and at all treatment visits, even when other assessments are not scheduled. 
n 
P,-ior and concoinitant medications should be collected at screening. Concoinitant medications should be recorded at all scheduled and unscheduled assessment visits, and at 
all treatment visits, even when other assessments are not scheduled. 
o 
Fotu· PRO instnuuents will be administered in this study: the EORTC QLQ-C30 questionnaire, the EQ-SD-SL, the PGIS, and the PGIC. The patient should complete these 
questionnaires before any other study procedures at required visits. EORTC QLQ-C30 and EQ-SD-SL questionnaires should be performed p1-ior to PGIS/PGIC. PGIC is not 
required at Cycle 1 Day 1. If the PRO instnuuents are not available in a patient's language, patients are not required to complete the assessments. Patients with other sitt1ations 
related to PRO instrtuuent completion (eg, visual impaiiment/blindness, liiuitation in upper extreinity mobility/dexte1-ity) may be exempt from these assessments after 
discussion with the sponsor. 
p 
Pe1-ipheral blood smears for blasts are to be collected along with bone mrul'Ow aspirate. 
q 
Samples w-ill be collected predose within 12 hours p1-ior to study treatment administration. 
r 
Sta,ting at Cycle 2 Day 1, peripheral blood samples for biomarker studies on Cycle X Day 1 do not need to be repeated at Day 1 of the cycle if they have been collected 
within the past 7 days. 
s 
If a bone mru1·ow aspii-ate sruuple is not evaluable, another aspii-ate sruuple must be peiformed within 7 days. At screening, th.is procedtu-e must be perfonued p1-ior to the fo-st dose 
of stt1dy treatment at the latest. An aspii-ate sruuple will be collected for 1-esponse assessment ( eg, blast evaluation), cytogenetics, MRD assessment (peiformed durin . the first 6 
c cles onl 
biomru-kei· srudies. and biobanking. For atients whose bone nlllll·ow as ii·ate is di 
not obtainable a ti-e hine bio 
le is 1-e uii-ed. If an 
nventiona cytogenetics ru·e to e teste pei· !llstitubona stan ru s. 
Response assessments may ea ~uste 
y ± 1 wee 
or Day 28 of Cycles 1 and 2. After Cycle 2 Day 28, the window is ± 14 days. Bone ma1l'Ow response infonuation from 
Day 28 may be requii·ed to decide start of the next cycle per dosing modification guidelines in the protocol. For patients whose bone ma1l'Ow aspirate is diy (not obtainable), a 
ti·ephine biopsy sample is requii·ed. 
u 
Bone mru1·ow biopsy (blocks) collected within 1 month p1-ior to the signing of infonued consent may be used in lieu of bone mru1-ow biopsy at screening. 
CONFIDENTIAL 
Page 167 
15 December 2023 


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Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 168
15 December 2023
Appendix 16.
Amendment History
A high-level summary of this amendment is provided in tabular form in the subsection below. 
Minor changes such as the correction of typographic errors, grammar, or formatting are not 
detailed. 
A separate tracked change (red-lined) document comparing Amendment 6 to this amendment 
will be made available upon the publication of this protocol.
Amendment 7 (15 December 2023)
Rationale for Key Changes Included in Amendment 7
Affected Sections
Specific information regarding the Gilead internal unblinded team was added to 
the planned interim unblinding section.
Section 5.1.3
Additional clarification was provided for azacitidine administration per local 
clinical practice guidelines.
Section 5.5.2
Magrolimab/placebo dose modification guidelines were revised for patients in 
remission with Grade 4 neutropenia or Grade 4 thrombocytopenia.
Section 5.5.3.1.2
Minor changes to correct typographic errors were applied.
Throughout, as needed


Prot GS-US-590-6154 amd-7
ELECTRONIC SIGNATURES
Signed by
Meaning of Signature
Server Date
(dd-MMM-
yyyy hh:mm:ss)
Clinical Development
eSigned
20-Dec-2023
20:13:15
PPD

SAP_001.pdf: 
Study Title: 
Name of Test Drug: 
Study Number: 
Protocol Version (Date): 
Analysis Type: 
Analysis Plan Version: 
Analysis Plan Date: 
Analysis Plan Authors: 
(r} GILEAU 
STATISTICAL ANALYSIS PLAN 
A Phase 3, Randomized, Double-Blind, Placebo-Controlled 
Study Evaluating the Safety and Efficacy ofMagrolimab 
versus Placebo in Combination with V enetoclax and 
Azaciti.dine in Newly Diagnosed, Previously Untreated Patients 
with Acute Myeloid Leukemia Who Are Ineligible for 
Intensive Chemotherapy 
Magrolimab 
GS-US-590-6154 
Original 
Amendment 1 
Amendment2 
Amendment3 
Amendment4 
Amendment 5 
Amendment6 
Amendment7 
Final Analyses 
1.0 
08 May 2024 
PPD 
PPD 
30 June 2021 
08 September 2021 
01 November 2021 
29 N ovem her 2021 
30 March 2022 
27 July 2022 
10 October 2023 
15 December 2023 
CONFIDENTIAL AND PROPRIETARY INFORMATION 


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Final
Statistical Analysis Plan – Final Analyses
Version 1.0
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08 May 2024
TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF ABBREVIATIONS.........................................................................................................................................5
1.
INTRODUCTION..................................................................................................................................................8
1.1.
Study Objectives........................................................................................................................................8
1.2.
Study Design ...........................................................................................................................................10
1.3.
Sample Size and Power ...........................................................................................................................13
2.
TYPE OF PLANNED ANALYSIS......................................................................................................................14
2.1.
Interim Analyses......................................................................................................................................14
2.1.1.
First Interim Analyses ...........................................................................................................14
2.1.2.
Second Interim Analyses.......................................................................................................14
2.2.
Primary Analysis .....................................................................................................................................14
2.3.
Final Analysis..........................................................................................................................................15
3.
GENERAL CONSIDERATIONS FOR DATA ANALYSES.............................................................................16
3.1.
Analysis Sets ...........................................................................................................................................16
3.1.1.
Intent-to-Treat (ITT) Analysis Set.........................................................................................16
3.1.2.
Safety Analysis Set................................................................................................................16
3.1.3.
Pharmacokinetic Analysis Set ...............................................................................................16
3.1.4.
Immunogenicity Analysis Set................................................................................................16
3.2.
Subject Grouping.....................................................................................................................................17
3.3.
Strata and Covariates...............................................................................................................................17
3.4.
Examination of Subject Subgroups .........................................................................................................17
3.5.
Multiple Comparisons .............................................................................................................................18
3.6.
Missing Data and Outliers.......................................................................................................................18
3.6.1.
Missing Data..........................................................................................................................18
3.6.2.
Outliers ..................................................................................................................................18
3.7.
Data Handling Conventions and Transformations ..................................................................................18
3.8.
Analysis Visit Windows..........................................................................................................................19
3.8.1.
Definition of Study Day ........................................................................................................19
3.8.2.
Analysis Visit Windows........................................................................................................19
3.8.3.
Selection of Data in the Event of Multiple Records in an Analysis Visit 
Window .................................................................................................................................22
4.
PROTOCOL DEVIATIONS................................................................................................................................24
4.1.
Assessment of COVID-19 Impact...........................................................................................................24
5.
SUBJECT INFORMATION ................................................................................................................................25
5.1.
Subject Enrollment and Disposition........................................................................................................25
5.2.
Extent of Study Drug Exposure and Relative Dose Intensity .................................................................26
5.2.1.
Duration of Exposure to Study Drug.....................................................................................26
5.2.2.
Relative Dose Intensity..........................................................................................................26
5.3.
Demographics and Baseline Characteristics ...........................................................................................27
5.4.
Other Baseline Characteristics ................................................................................................................27
5.5.
Medical History.......................................................................................................................................28
5.6.
Prior Anti-Cancer Therapy......................................................................................................................28
5.7.
Prior and On Study Radiotherapy............................................................................................................28
5.8.
Surgeries and Procedures ........................................................................................................................28
5.9.
Prior Study Transfusion...........................................................................................................................28


Magrolimab 
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Version 1.0 
Statistical Analysis Plan - Final Analyses 
5.10. 
Prior and Concomitant Medications ........................................................................................................ 28 
5.10.1. 
Prior Medications .................................................................................................................. 28 
5.10.2. 
Conco1nitant Medications ...................................................................................................... 29 
5.11. 
Left Venti·icular Ejection Fraction Results .............................................................................................. 29 
5.12. 
Post Treatment Anti-cancer Therapy ....................................................................................................... 29 
6. 
EFFICACY ANALYSES ..................................................................................................................................... 30 
6.1. 
Pri1nruy Efficacy Endpoints .................................................................................................................... 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 the Prima1y Efficacy Endpoint.. ......................................................................... 31 
6.1.4. 
Follow-up Time ..................................................................................................................... 31 
6.1.5. 
Sensitivi Anal sis of the Primru Efficac End oint.. ....................................................... 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 ........................................................... 34 
6.3. 
Estimands for Primru and Ke Seconda1 End oints ........................................................................... 35 
■ 
6.5. 
Patient-Repo1ted Outco1ne ..................................................................................................................... .40 
6.5 .1. 
Definition of Patient-Repo1ted Outcome Data ..................................................................... .40 
6.5.2. 
Analysis of Patient-Repo1ted Outcome Data ....................................................................... .40 
7. 
SAFETY ANALYSES ........................................................................................................................................ .41 
7 .1. 
Adverse Events and Deaths .................................................................................................................... .41 
7 .1.1. 
Adverse Event Dictiona1y .................................................................................................... .41 
7.1.2. 
Adverse Event Severity ........................................................................................................ .41 
7.1.3. 
Relationship of Adverse Events to Study Dmg .................................................................... .41 
7 .1.4. 
Serious Adverse Events ........................................................................................................ .41 
7 .1.5. 
Treatinent-Emergent Adverse Events ................................................................................... .41 
7.1.6. 
SUllllllaries of Adverse Events and Deaths ............................................................................ 42 
7 .1. 7. 
Additional Analysis of Adverse Events ................................................................................ 44 
7.2. 
Laborato1y Evaluations .......................................................................................................................... .45 
7.2.1. 
SUllllllaries of Numeric Laborat01y Results ......................................................................... .45 
7.2.2. 
Graded Laborato1y Values ................................................................................................... .46 
7.2.3. 
Shifts Relative to the Baseline Value .................................................................................... 47 
7.3. 
Body Weight and Vital Signs ................................................................................................................. .47 
7.4. 
Electrocru·diogra1n Results ...................................................................................................................... .47 
7.5. 
Other Safety Measures ........................................................................................................................... .47 
7.6. 
Changes from Protocol-Specified Safety Analyses ................................................................................ .47 
8. 
PHARMA CO KINETIC (PK) AND IMMUNOGENECITY ANALYSES ........................................................ .48 
8.1. 
PK Sample Collection ............................................................................................................................ .48 
8.2. 
PK Analyses ........................................................................................................................................... .48 
8.3. 
Irmnunogenicity Analysis ....................................................................................................................... .49 
9. 
PHARMACODYNAMIC ANALYSES .............................................................................................................. 51 
10. REFERENCES ..................................................................................................................................................... 52 
11. SOFTWARE ......................................................................................................................................................... 53 
12. SAP REVISION ................................................................................................................................................... 54 
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13.
APPENDICES......................................................................................................................................................55
Appendix 1.
Schedule of Assessments.........................................................................................................56
Appendix 2.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria..........................................................................65
LIST OF IN-TEXT TABLES
Table 1-1.
Dose Level and Schedule ........................................................................................................11
Table 3-1.
Analysis Visit Windows for Hemoglobin ...............................................................................20
Table 3-2.
Analysis Visit Windows for Calcium/ Creatinine/ Phosphorus/ Potassium/Uric Acid...........21
Table 3-3.
Analysis Visit Windows for Remaining Lab...........................................................................22
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 ....................................................................37


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Version 1.0
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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
CMH
Cochran-Mantel-Haenszel
COVID-19
Corona Virus 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
HLT
high-level term
HLGT
high-level group term
HRQoL
health-related quality of life


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IA
Interim analysis
ICH
International Conference on Harmonization
ID
identification
IPD
mportant protocol deviation
ITT
Intent-to-Treat
IWG
International Working Group
IRR
infusion related reaction
IRT
interactive response technology
LLT
lower-level term
LOQ
limit of quantitation
LVEF
left ventricular ejection fraction
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
PBIR
probability of being in response
PP
per-protocol
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
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


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ULN
upper limit of normal
US
United States
WBC
White blood cell
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 analysis specified in 
the study protocol for Study GS-US-590-6154.
This SAP is based on GS-US-590-6154 Protocol Amendment 7 dated 15 December 2023. The 
SAP will be finalized prior to data finalization for the final analysis. 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 + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine in patients with previously untreated AML who are 
ineligible for intensive chemotherapy as measured by overall survival (OS)
The secondary objectives of this study are as follows:
•
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine as measured by the rate of complete remission 
(CR) + complete remission with partial hematologic recovery (CRh) within 6 cycles of 
treatment
•
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine as measured by the rate of CR within 6 cycles of 
treatment
•
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine as measured by event-free survival (EFS)
•
To evaluate the duration of CR + CRh in patients who achieved CR or CRh within 6 cycles 
of treatment
•
To evaluate the duration of complete remission (DCR) in patients who achieved CR within 
6 cycles of treatment 
•
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine as measured by rate of CR + CRh without minimal 
residual disease (MRD-) within 6 cycles of treatment
•
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine as measured by rate of CR without minimal residual 
disease (CRMRD-) within 6 cycles of treatment


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To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
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placebo + venetoclax + azacitidine as measured by conversion rate of transfusion dependence 
to transfusion independence 
• 
To compare the efficacy of magrolimab + venetoclax + azacitidine versus 
placebo+ venetoclax + azacitidine as measured by time to first deterioration (TTD) on the 
global health status/quality oflife (GHS/QoL) and the physical functioning scales of the 
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 
(EORTC QLQ-C30) 
• 
To assess the safety and tolerability of magrolimab + venetoclax + azacitidine versus 
placebo + venetoclax + azacitidine 
• 
To evaluate the phannacokinetics (PK) and immunogenicity of magarolimab 
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1.2. 
Study Design 
Final 
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This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and 
efficacy of magrolimab versus placebo in combination with venetoclax and azacitidine in newly 
diagnosed, previously untreated patients with AML who are ineligible for intensive 
chemotherapy. Approximately 432 patients will be randomized in 1: 1 ratio to receive either 
magrolimab + venetoclax + azacitidine ( experimental aim) or placebo + venetoclax + azacitidine 
(control aim). Randomization will be strntified by 3 factors: 
• 
age(< 75 yeai·s, ~ 75 yeai·s) 
• 
genetic risk group (favorable/inte1mediate, adverse, unknown) 
• 
geographic region (United States [US], outside the US) 
Newly diagnosed, 
previously untreated AML 
patients w ho are ineligible 
for intensive chemotherapy 
(based on objective 
criteria) 
Prim:iry Endpoint : 
Overall Su rvlval 
CONFIDENTIAL 
------- ~[ --~ 
1:1 randomization 
N=216 
-----. 
Placebo t- venetoclax --t- aucitidine 
N=216 
Page 10 
Stratifications: 
1. 
Age (<75 years,~ 75 years) 
2. 
Genetic risk group (favorable/ 
intermediate, adverse, unknown) 
3. 
Geographic region (US, outside the 
US) 
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The primary endpoint is OS. Two interim OS analyses will be conducted, the first one after 
121 deaths (40% of the expected 303 deaths), and the second one after 227 deaths (75% of the 
expected 303 deaths) are observed among all patients; the primary OS analysis will be conducted 
after 303 deaths have occurred.Following completion of screening and admission assessments, 
eligible patients will be randomized in 1:1 ratio to receive either 
magrolimab + venetoclax + azacitidine (experimental arm) or placebo + venetoclax + azacitidine 
(control arm).
The study treatments within each arm are described in Table 1-1:
Table 1-1.
Dose Level and Schedule
Dose Schedule 
(Day per 28-day Cycle)
Treatment 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
Azacitidine
75 mg/m2 SC or IVa
Days 1-7 or
Days 1-5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
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  5 doses
Experimental arm 
(magrolimab + 
venetoclax + azacitidine)
Magrolimab 30 mg/kg IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly 30 mg/kg dose
Venetoclax 100 mg oral
Day 1
—
—
Venetoclax 200 mg oral
Day 2
—
—
Venetoclax 400 mg oral
Day 3 and daily 
thereafter
Daily
Daily
Azacitidine 
75 mg/m2 SC or IVa
Days 1-7 or
Days 1–5 and 8-9
Days 1-7 or
Days 1-5 and 8-9
Days 1–7 or
Days 1-5 and 8-9
Placebo Administration
Placebo IV
(over 3 hours)
Days 1, 4
Placebo IV
(over 3 hours)
Day 8
Placebo IV
(over 2 hours)
Days 11 and 15, and then QW  5 doses
Control arm (placebo + 
venetoclax + azacitidine)
Placebo IV
(over 2 hours)
Q2W beginning 1 week after the fifth weekly
IV = intravenous; PO = orally; QW = every week; Q2W = every 2 weeks; SC = subcutaneous
a
Azacitidine administered per region-specific labeling.


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Cycle lengths are 28 days, and all patients will continue on study treatment until disease 
progression, relapse, loss of clinical benefit, unacceptable toxicities or other study treatment 
discontinuation criteria are met. Clinical benefit, as determined by the investigator, can include 
transfusion independence, adequate blood counts, symptomatic improvement, or other criteria as 
determined by the investigator.
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.
Patients will continue follow-up study visits unless they withdraw completely from the study.
All patients discontinue study treatment for reasons other than death or start of new anti-AML 
therapy (except maintenance and SCT) will participate in long-term follow-up for disease 
response unless the patient withdraws consent for such follow-up and withdraws completely 
from study. 
In the event one or more components of the study treatment (magrolimab/placebo, azacitidine 
and/or venetoclax) are discontinued, the following combinations are permitted:
•
Magrolimab/placebo + azacitidine
•
Azacitidine (single agent)
•
Venetoclax + azacitidine
The following combinations are not permitted:
•
Magrolimab/placebo (single agent)
•
Venetoclax (single agent)
•
Magrolimab/placebo + venetoclax
If azacitidine is permanently discontinued, the patient must discontinue the remaining study 
treatment. Patients who discontinue study treatment 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, withdrawal of consent, loss to follow-up, 
completion of survival follow-up, or study termination by the sponsor, whichever occurs first. 
Duration of survival follow-up will be limited to 5 years from the end of treatment visit for each 
patient. 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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Following the independent data monitoring committee (DMC) meeting that occurred on 
2 February 2024 for a planned futility analysis based on OS, Gilead has decided to terminate the 
study based on the determination of futility.
1.3.
Sample Size and Power
The study will randomize approximately 432 patients in total into 2 treatment arms at a 1:1 ratio, 
determined by formal hypothesis testing performed on the primary efficacy endpoint: OS, with 
family-wise Type I error controlled at 1-sided significance level of 0.025.
It is assumed that administration of magrolimab + venetoclax + azacitidine to study patients will 
result in a median OS of approximately 21 months, improved from a median OS of 14.7 months 
in patients treated with placebo + venetoclax + azacitidine. This corresponds to an OS HR of 0.7. 
Assuming 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, 303 events 
are needed to detect an HR of 0.7 with 86.4% power at a 1-sided significance level of 0.025 
using a log-rank test, the first interim analysis with futility test when 40% of the information 
(121 deaths) is available, and the second interim analysis with superiority test together with a 
futility test when 75% of the information (227 deaths) is available, and one primary analysis. For 
the second OS interim analysis and the OS primary analysis, the Lan-DeMets alpha spending 
function with O’Brien-Fleming stopping boundary will be used. The futility boundaries for two 
interim analyses are obtained using a Gamma beta-spending function with parameter -5.
With an accrual period of 19 months (with approximately 51% of the patients enrolled during the 
initial 12 months, and the remaining 49% of the patients enrolled during the last 7 months), 
24 months of follow up, and an annual 1.43% dropout rate (5% dropout chance by 43 months 
with time to dropout assuming exponentially distributed time-to-dropout), a total sample size of 
432 patients (216 patients per treatment group) is needed to observe the required 303 events.


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2.
TYPE OF PLANNED ANALYSIS
2.1.
Interim Analyses
An external multidisciplinary Data Monitoring Committee (DMC) will review the progress of 
the study, perform interim reviews of safety data at regular intervals, and provide 
recommendation to Gilead whether the nature, frequency, and severity of AEs associated with 
study treatment warrant the early termination (ET) of the study in the best interests of the patient, 
whether the study should continue as planned, or whether the study should continue with 
modifications. The DMC may also provide recommendations as needed regarding study design. 
In addition, the DMC will review the results from the 2 interim analyses. Based on the 
pre-specified superiority and futility rules, the DMC may make recommendations to Gilead as to 
whether the study should be stopped early due to overwhelming efficacy, be terminated for 
futility, or continue as planned. Efficacy superiority and futility boundaries are specified in study 
protocol Section 8.2.
The DMC’s specific activities will be defined by a mutually agreed charter, which will define 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.
Two OS interim analyses (IA) are planned. 
2.1.1.
First Interim Analyses 
The first interim analysis will be performed when approximately 121 deaths (40% of the 
expected 303 deaths) have occurred, outstanding data queries have been resolved or adjudicated 
as unresolvable, and the data have been cleaned and finalized. An administrative 1-sided 
alpha =0.0001 is allocated to this interim analysis. The nonbinding futility analysis with a futility 
boundary of HR = 1.1 will be performed. A Gamma beta-spending function with parameter -5 is 
used to obtain the futility boundaries for both interim analysis. 
2.1.2.
Second Interim Analyses 
The second interim analyses for the study will not be conducted since the study was terminated 
after the planned futility analysis.
2.2.
Primary Analysis
Not applicable.


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2.3.
Final Analysis
The final analysis will be performed after all patients have completed or discontinued the study, 
outstanding data queries have been resolved or adjudicated as unresolvable, and the data have 
been cleaned and finalized. 
Following the independent data monitoring committee (DMC) meeting that occurred on 
2 February 2024 for a planned futility analysis based on OS, Gilead has decided to terminate the 
study based on the determination of futility. By the time the sponsor makes the decision to end 
the study, 378 patients have been randomized, which is less than the planned sample size of 
432 patients. 


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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 randomized patients according to the treatment arm to which 
the patients are randomized, unless otherwise specified. This is the primary analysis set for 
efficacy analysis.
3.1.2.
Safety Analysis Set
The Safety Analysis Set includes all patients who received at least 1 dose of any study treatment, 
with treatment assignments 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 includes all randomized patients who took at least one 
dose of magrolimab and have at least 1 measurable (non - below the limit of quantitation (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 includes all randomized patients who received at least 
one dose of magrolimab and had at least one evaluable anti-magrolimab antibody test result. 


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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 using an interactive response 
technology (IRT) with a stratified randomization schedule. Stratification will be based on the 
following variables:
•
age (< 75 years, ≥ 75 years) 
•
genetic risk group (favorable/intermediate, adverse, unknown)
•
geographic region (United States [US], outside the US)
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:
•
age (< 75 years, ≥ 75 years) 
•
genetic risk group (favorable/intermediate, adverse, unknown)
•
geographic region (US, outside the US)
The analysis may also be conducted in the subgroups by 
•
TP53 mutation status (mutant, wild type)
•
ECOG (0-1, 2-3)


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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 
secondary efficacy endpoints. 
3.5.
Multiple Comparisons
The adjustment for multiple comparisons is not applicable since the study has been terminated. 
Nominal P-values will be provided if applicable.
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.
The handling of missing or incomplete dates initial AML diagnosis is described in Section 5.5, 
for date of death is described in Section 6.1.1, for 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 5.10.1 and 5.10.2. 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.


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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 LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “< x” (where x is considered the LOQ). For example, if the 
values are reported as < 50 and < 5.0, values of 49 and 4.9, respectively, will 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 LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “> x” (where x is considered the LOQ). Values with decimal 
points will follow the same logic as above.
•
The 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 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 date of the 
first dose of magrolimab/placebo, venetoclax or azacitidine, whichever occurs first 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
Patient 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 are 
provided in Table 3-1 to Table 3-3. 


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Table 3-1.
Analysis Visit Windows for Hemoglobin
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
Unscheduledd, post-dose
1c
1
Day 2
2
2
2
Day 3
3
3
3
Day 4 pre-dose
Set 1 Day 4, pre-dose
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 Day1 in study day calculation if subjects are administered 
magrolimab/placebo. 
b
On or prior to first magrolimab/placebo date/time if the patient is infused with magrolimab/placebo, 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 
Day 4 post-dose.


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Table 3-2.
Analysis Visit Windows for Calcium/ Creatinine/ Phosphorus/ 
Potassium/Uric Acid
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
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
Cycle 1 Day 4
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 3 Post-Dose 24 Hour
Cycle 1 Day 3, 24 Hour Post-Dose
Unschedulede, 24 Hour post-dose
NA
NA
Week 1
8
4
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 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 
is mapped to Day 3 post-dose 24 hour.


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Table 3-3.
Analysis Visit Windows for Remaining Lab
Visit Window Study Day
Analysis Visit
Nominal Study Day
Lower Limit
Upper Limit
Baseline
1a
Week 1
8
1b
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
Post first dose date/time of any study drug
Any data relating to unscheduled visits will not be assigned to a particular visit or time point. 
However, the following exceptions will be made:
•
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 


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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.
PROTOCOL DEVIATIONS
Patients who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
listed. 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.
Protocol deviations occurring after patients entered the study are documented during routine 
monitoring. The number and percentage of patients with important protocol deviations, with 1, 2, 
or 3 or more important protocol deviations, and the total number of important protocol deviations 
by deviation reason (eg, nonadherence to study drug, violation of select inclusion/exclusion 
criteria) 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.
4.1.
Assessment of COVID-19 Impact
The study was ongoing during the novel coronavirus (COVID-19) pandemic which has an 
impact on the study conduct. The following by-subject listings will be provided:
•
Study drug discontinuation Due to COVID-19
•
Protocol deviations due to COVID-19
•
Missed or virtual visits due to COVID-19
•
Adverse events due to COVID-19


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5.
SUBJECT INFORMATION
5.1.
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, the number of patients screen failed, and the number of 
patients in each of the categories listed below by treatment group:
•
ITT Analysis Set
•
Safety Analysis Set 
•
Discontinued study treatment (magrolimab + venetoclax + azacitidine, placebo + venetoclax 
+ azacitidine ) with reasons for discontinuation
•
Discontinued study with reasons for discontinuation
For the reasons of study drug discontinuation and study 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 listings 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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5.2.
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/placebo, 
venetoclax, and azacitidine separately. No formal statistical testing between treatment group is 
planned. 
5.2.1.
Duration of Exposure to Study Drug
Total duration of exposure to each study drug (magrolimab/placebo, 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, 4 weeks, 8 weeks, 12 weeks, 
16 weeks, 20 weeks, and 24 weeks, etc. 
The number of cycles patients exposed to venetoclax and azacitidine will be summarized using 
descriptive statistics, and the number and percentage of patients who received at least 1, 2 …, 
6 cycles will be presented.
The number and percentage of patients who have dose reduction or delay for each drug and the 
reasons will be summarized. 
By-subject listings of study drug administration will be provided.
5.2.2.
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/Placebo:
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 Dosage of Magrolimab/Placebo 
Administered (in mg/kg)
M grolimab/Placebo Dosage Expected to be Administere  
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. 
 


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Magrolimab/placebo dosage expected to be administered on treatment (mg/kg) for each subject 
is defined as the total amount of magrolimab/placebo 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/m^2) 
Azacitidine Expected to be Administered on Treatment (mg/m^2)  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, concomitatnt medications in Posaconazole/Other Strong CYP3A 
inhibitor/Moderate CYP3A inhibitor/P-gp inhibitor will be considered to reduce the amount of 
venetoclas expected to be administered.
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).
5.3.
Demographics and Baseline Characteristics
Subject demographic variables (ie, age, age group [< 75 years, ≥ 75 years], sex, race/ ethnicity) 
and baseline characteristics (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.
5.4.
Other Baseline Characteristics
Other baseline characteristics include but are not limited to TP53 mutational status, 
Eastern Cooperative Oncology Group (ECOG) performance status, and World Health 
Organization (WHO) AML classification. 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.
 
 
 


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5.5.
Medical History
Medical history will be collected at screening for disease-specific and general conditions 
(ie, conditions not specific to the disease being studied).
Time since diagnosis (months) will be calculated by (date of randomization – date of diagnosis) / 
30.4375. -In deriving the time since disease diagnosis, all partial dates of diagnosis and last 
regimen will be identified, and the partial dates will be imputed as follows:
•
If day and month are missing but year is available, then the imputed day and month will be 
01 Jan.
•
If day is missing but the month and year are available, then the imputed day will be the 
first day of the month.
•
Partial date will not be imputed if the year is missing.
A by-subject listing of general medical history will be provided by subject ID number in 
ascending order.
5.6.
Prior Anti-Cancer Therapy
No summary or listing of prior anti-cancer therapy will be provided.
5.7.
Prior and On Study Radiotherapy
No summary or listing of on study radiotherapy will be provided.
5.8.
Surgeries and Procedures
No summary or listing of surgeries and procedures will be provided.
5.9.
Prior Study Transfusion
No summary or listing of prior study transfusion will be provided.
5.10.
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.
5.10.1.
Prior Medications
Prior medications are defined as any medications taken before a subject takes the first study 
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Any medication with a start date prior to the first dosing date of study drug will be considered as 
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 as prior medication, unless otherwise specified. 
No summary of prior medications will be provided. 
5.10.2.
Concomitant Medications
Concomitant medications are defined as medications taken while a subject took study drug. 
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. 
No summary of concomitant medications will be provided.
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.
5.11.
Left Ventricular Ejection Fraction Results
No summary or listing of left ventricular ejection fraction results will be provided.
5.12.
Post Treatment Anti-cancer Therapy
Post treatment anti-cancer therapy will be provided in a by-subject listing sorted by subject ID 
number and administration date in chronological order.


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6.
EFFICACY ANALYSES
6.1.
Primary Efficacy Endpoints
6.1.1.
Definition of Primary Efficacy Endpoint
The primary efficacy endpoint of this study is OS. 
Overall Survival: The OS is measured 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 their last 
known alive date.
The date of the last known alive will be determined by selecting the last available date of the 
following study procedures for a subject: ADA sample collection, adverse event, anti-cancer 
therapy, bone marrow assessments, concomitant medication, consents, AML cancer diagnosis 
history, ECHO or MUGA scans, ECG performance date, study drug administration, cytogenetic 
assessment, healthcare encounters, enrollment, molecular markers, medical history, AML 
response assessment, biomarkers and PK sample collection, protocol deviation, radiotherapy, 
transfusion, performance status, PRO assessment, transfusion, clinical laboratory collection, 
SCT, surgeries and procedures, survival follow-up, and site transfer.
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 + 
venetoclax + azacitidine (experimental arm) and placebo + venetoclax + azacitidine (control 
arm) in OS for patients. Using Sexp(t) and Sctrl(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: Sexp(t) = Sctrl(t)
    𝐻1: Sexp(t) > Sctrl(t) (experimental arm is superior to control arm in terms of OS)


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6.1.3.
Analysis of the Primary Efficacy Endpoint
The primary analysis of OS will compare the OS distributions of two treatment groups 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 6, 12 and 18 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. 
In addition, the HR between the 2 treatment groups and its 95% CI will be estimated using the 
Cox proportional hazards regression model stratified by the stratification factors. 
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 on or prior to the data cutoff, 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 up to the 
data cutoff or lost 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 Analysis of the Primary Efficacy Endpoint
No sensitivity analysis of the primary efficacy endpoint is planned.
6.2.
Secondary Efficacy Endpoints
6.2.1.
Definition of Secondary Efficacy Endpoints
Rate of CR + CRh Within 6 Cycles of Treatment: 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 2) within 6 cycles of treatment 
while on study prior to initiation of any new anti-AML therapy or SCT.
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.
CCI


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Rate of CR Within 6 Cycles of Treatment: 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 cycles of treatment, as determined by investigators based on the ELN 2017 
for AML with modifications (Appendix 2) while on study prior to initiation of any new 
anti-AML therapy or SCT.
Event-Free Survival: 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 cycles of treatment), 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 specified events on or prior to data cutoff date 
(the date on which subsequently collected data will not be considered as part of the analysis) will 
be censored at the date of their last response assessment with clear documentation of no relapse 
on or prior to the data cutoff date. Patients will be censored at the date of randomization if no 
response assessment performed after randomization and the patients didn’t die. 
Table 6-1 summarizes the details of the EFS derivation algorithm
Table 6-1.
Censoring Rules for EFS
Situation
Event/Censored
Event/Censored Date
Had relapse or death
Event
(Relapse/death)
Relapse date or death 
date whichever comes 
first
Achieved CR* within 6 cycles 
from the randomization date
No relapse or death
Censored
Last assessment date
Had progression, death or new 
anti-AML therapies within 
6 cycles
Event
(Treatment 
Failure)
Randomization Date
No progression, death or new 
anti-AML therapies within 
6 cycles, and have been on 
study beyond 6 cycles
Event
(Treatment 
Failure)
Randomization Date
Within 6 cycles, had at least 
one post-baseline response 
assessment, but didn’t achieve 
CR 
No progression, death or new 
anti-AML therapies within 
6 cycles, and haven’t been on 
study beyond 6 cycles
Censored
Randomization Date
Had death or new anti-AML 
therapies within 6 cycles
Event
(Treatment 
Failure)
Randomization Date
Within 6 cycles, had no 
post-baseline response 
assessment
No death or new anti-AML 
therapies within 6 cycles
Censored
Randomization Date
*
CRs achieved within 6 cycles of treatment and before SCT or new anti-AML therapies.


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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 cycles of 
treatment 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 on or prior to the data cutoff 
date. 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. 
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 cycles of treatment 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 on or prior to the data cutoff date. 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.
Rate of CR/CRhMRD- Within 6 Cycles of Treatment: the CR/CRhMRD- rate is the proportion of 
patients who achieve a CRMRD- or CRhMRD- within 6 cycles of treatment while on study prior to 
initiation of any new anti-AML therapy or SCT. The threshold for MRD negativity in this study 
is a frequency of less than 1 × 10-3 phenotypic leukemic cells per total white blood cell (WBC).
Rate of CRMRD- Within 6 Cycles of Treatment: the CRMRD- rate is the proportion of patients 
who achieve a CRMRD- within 6 cycles of treatment, as determined by investigators based on the 
ELN 2017 for AML with modifications (Appendix 2), while on study prior to initiation of any 
new anti-AML therapy or SCT. The threshold for MRD negativity in this study is a frequency of 
less than 1 × 10-3 phenotypic leukemic cells per total WBCs.
Transfusion Independence Conversion Rate: The transfusion independence conversion rate 
includes both RBC transfusion independence rate and platelet transfusion independence rate.
RBC Transfusion Independence Conversion Rate: The RBC transfusion independence 
conversion rate is the proportion of patients who have a 56-day or longer period with no RBC 
nor whole blood transfusions at any time between the date of first dose of study treatment and 
discontinuation of study treatment among all patients who are RBC transfusion-dependent at the 
baseline. The RBC transfusion dependence at baseline is defined as having received an RBC or 
whole blood transfusion within the 28 days prior to the first dose of study treatment.
Platelet Transfusion Independence Conversion Rate: The platelet transfusion independence 
conversion rate is the proportion of patients who have a 56-day or longer period with no platelet 
transfusions at any time between the date of first dose of study treatment and discontinuation of 
study treatment among all patients who are platelet transfusion-dependent at baseline. Platelet 
transfusion dependence at baseline is defined as having received a platelet transfusion within the 
28 days prior to the first dose of study treatment.


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Time to First Deterioration on the EORTC QLQ-C30 GHS/QoL Scale: the TTD on the 
EORTC QLQ-C30 GHS/QoL scale is defined as time from the date of randomization to the time 
a patient experienced at least 1 threshold value deterioration from baseline or death, whichever is 
earlier. Patients whose score does not reach 1 threshold value deterioration from baseline and 
with no death will be censored at their last assessment date. Patients with no baseline values, or 
no post baseline values or the baseline value less than the threshold will be censored on 
randomization date. Patients with missing two or more consecutive visits will be censored at the 
last available assessment visit with non-missing value. In the analysis, 1 threshold value 
deterioration will be defined as the 10-point threshold from literature. {Osoba 1998}
Time to First Deterioration on the EORTC QLQ-C30 Physical Functioning Scale: the TTD 
on the EORTC QLQC30 physical functioning scale is defined as time from the date of 
randomization to the time a patient experienced at least 1 threshold value deterioration from 
baseline or death, whichever is earlier. Patients whose score does not reach 1 threshold value 
deterioration from baseline and with no death will be censored at their last assessment date. 
Patients with no baseline values, or no post baseline values or the baseline value less than the 
threshold will be censored on randomization date. Patients with missing two or more consecutive 
visits will be censored at the last available assessment visit with non-missing value. In the 
analysis, 1 threshold value deterioration will be defined as the 10-point threshold.
6.2.2.
Analysis Methods for Secondary Efficacy Endpoints
Key secondary efficacy endpoints will be tested according to the order specified in Section 3.5, 
after the superiority for the primary efficacy endpoint is established. 
6.2.2.1.
Event-Free Survival 
The distribution of EFS 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 6, 12 and 18 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 will be estimated using the Cox proportional hazards regression model stratified 
by the stratification factors.
6.2.2.2.
RBC and Platelet Transfusion Independence Conversion Rates 
The point estimates of RBC and platelet transfusion independence conversion rates and the 
corresponding 2-sided exact 95% CIs based on Clopper-Pearson method will be provided by 
treatment arm respectively. Estimation will be based on a subset of all randomized patients who 
are RBC/platelet transfusion dependent at baseline. The transfusion independence conversion 
rate between treatment group will be compared using the Cochran-Mantel-Haenszel test, 
stratified by the randomization stratification factors.


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6.2.2.3.
CR+CRh Rate, CR Rate, CR/CRhMRD- Rate, CRMRD- Rate within 6 Cycles and 
Durations of Response
The analysis of CR+CRh rate, CR rate, CR/CRhMRD- rate and CRMRD- rate within 6 cycles will 
compare each response rate of two treatment groups using the Cochran-Mantel-Haenszel (CMH) 
test, stratified by the stratification factors at randomization. Odds ratio comparing the 2 arms 
adjusted for the stratification factors will be presented along with 95% confidence interval (CI).
The point estimate of each response rate within 6 cycles and the corresponding 2-sided exact 
95% CI based on the Clopper-Pearson method will be provided for each arm. Patients, who are 
randomized but have no on-study response assessment or receive any new anti-AML therapy or 
SCT prior to achieving the response, will be considered as non-responders.
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, and the Kaplan-Meier plots will be provided.
6.2.2.4.
TTD on the EORTC QLQ-C30 GHS/QoL and Physical Functioning Scales
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). Patients rate items on a four-point scale, with 1 as "not at all" and 4 as "very much", 
except that the GHS/QoL have 7-point scale. A higher score for a functional scale (e.g., physical 
functioning) or the global health status/QOL scale represents a better level of functioning or 
health status, whereas a higher score for a symptom scale represents a worse level of 
symptomatology.
Raw scores of the GHS/QoL and physical functioning scales will be transformed to 0-100 before 
analysis according to the current EORTC QLQ-C30 Scoring Manual (3rd 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 stratified by randomization 
stratification factors will be conducted for the TTD comparison between treatment arms, and the 
HR estimated using a Cox proportional hazard regression model stratified by randomization 
stratification factors will be provided.
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 and supplementary analyses 
are not included in the hierarchical testing (Section 3.5). 


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For all the estimands of the primary objectives and secondary objectives listed in the tables 
except for RBC/platelet transfusion independence conversion, the target population attribute is 
all AML patients defined by the study inclusion and exclusion criteria. For RBC/platelet 
transfusion independence conversion rates, the target population attribute is the AML 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 + 
venetoclax + 
azacitidine 
(experimental 
arm) vs. placebo + 
venetoclax + 
azacitidine 
(control arm), and 
with SCT/new 
anti-AML therapy 
as needed
OS
•
Discontinuation of treatment: 
treatment policy
•
SCT: treatment policy 
•
New anti-AML therapy: treatment 
policy 
•
Loss to follow-up: hypothetical
Difference in OS distribution 
between the experimental arm 
and the control arm, regardless 
of whether patients discontinue 
study treatment or receive SCT 
or initiate new anti-AML 
therapy
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.
Test the difference by a stratified 
longrak test in PP analysis set; 
Estimate the hazard ratio from a 
stratified Cox regression model in PP 
analysis set.
magrolimab + 
venetoclax + 
azacitidine 
(experimental 
arm) vs. placebo + 
venetoclax + 
azacytidine 
(control arm)
CR+CRh rate/ 
CR rate/ CR/
CRhMRD- rate/ 
CRMRD- rate
•
Discontinuation of 
treatment:treatment policy
•
SCT: while-on-treatment
•
New anti-AML therapy: 
while-on-treatment
•
Loss to follow-up: while-on-treatment
Difference in CR+CRh rate / 
CR rate / CR/CRhMRD- rate /
CRMRD- rate between the 
experimental arm and the 
control arm within 6 cycles of 
treatment, regardless of 
whether patients discontinue 
study treatment, prior to 
initiation of SCT or new anti-
AML therapy
Main Estimator: Test the difference 
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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Treatments
Variable 
(Endpoint)
Intercurrent Events & Strategies
Population Level Summary
Estimators
magrolimab + 
venetoclax + 
azacitidine vs. 
placebo + 
venetoclax + 
azacitidine, and 
with SCT as 
needed
EFS
•
Discontinuation of treatment: 
treatment policy
•
Death, Treatment failure: composite
•
SCT: treatment policy (after initial 
CR) and while-on-treatment (before 
initial CR)
•
New anti-AML therapy: treatment 
policy (after initial CR) and while-on-
treatment (before initial CR)
•
Missing >=2 consecutive response 
assessments: treatment policy
•
Loss to follow-up: hypothetical
Difference in EFS distribution 
between the experimental arm 
and the control arm, regardless 
of whether patients discontinue 
study treatment or receive SCT 
or initiate new anti-AML 
therapy
Main Estimator: Test the difference 
by a stratified logrank test;
Estimate hazard ratio from a stratified 
Cox regression model.
magrolimab + 
venetoclax + 
azacitidine vs. 
placebo + 
venetoclax + 
azacitidine
RBC/platelet 
transfusion 
independence 
conversion 
rate 
•
Discontinuation of treatment: 
while-on-treatment
•
Dose reduction or temporary delay: 
treatment policy
•
Loss to follow-up: while-on-treatment
Difference in RBC/platelet 
transfusion independence 
conversion rate between the 
experimental arm and the 
control arm, while patients 
receive study treatment
Main Estimator: Test the difference 
in terms of odds ratio by a stratified 
Cochran-Mantel-Haenszel test;
Estimate rate and CIs based on the 
Clopper-Pearson method.
magrolimab + 
venetoclax + 
azacitidine vs. 
placebo + 
venetoclax + 
azacitidine
TTD on 
GHS/QoL 
scale / TTD 
on physical 
functioning 
scale
•
Discontinuation of treatment: 
treatment policy
•
Death: composite
•
Loss to follow-up: hypothetical
Difference in TTD distribution 
between the experimental arm 
and the control arm while on 
study treatment
Main Estimator: Test the difference 
by a stratified logrank test;
Estimate hazard ratio from a stratified 
Cox regression model. 


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6.5.
Patient-Reported Outcome
6.5.1.
Definition of Patient-Reported Outcome Data
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 EORTC QLQ-C30 measure is described in Section 6.2.2.4.
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 10. 
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 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.
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.
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 for health-related quality of life and the physical function. The questionnaires are 
provided in the protocol Appendix 11.
6.5.2.
Analysis of Patient-Reported Outcome Data
For TTD on the EORTC QLQ-C30 GHS/QoL and Physical Functioning Scales, the analysis 
method is described in Section 6.2.2.4.
CCI


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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 v26.0. 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 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 comes first. If the 
AE onset date is on or before the last dose date, the AE is considered as TEAE regardless of the 
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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 date of the last dose of 
study treatment plus 70 days or the day before initiation of new anti-AML therapy including 
SCT, whichever comes 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 of percentage of patients who experienced at least 
1 TEAE in the categories will be provided by treatment group. All deaths observed in the study 
will also be included in this summary.


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For the AE categories described below, summaries will be provided by SOC, PT, and treatment 
group:
•
TEAEs
•
TEAEs with Grade 3 or higher
•
TE treatment-related AEs for Magrolimab/Placebo
•
TE SAEs
•
TE treatment-related SAEs for each study drug
•
TEAEs leading to discontinuation of each study drug
•
TEAEs leading to dose reduction of each study drug 
•
TEAEs leading to drug interruption of each study drug 
•
TEAEs leading to death 
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by PT, severity and treatment group:
•
TE treatment-related AEs for each study drug
The number and percentage of patients who experienced at least 1 TEAE will be provided and 
summarized by SOC, PT, maximum severity, and treatment group for the following categories:
•
TEAEs with Grade 3 or higher
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 
TE treatment-related AEs and TE treatment-related 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


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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 within 70 days of the last dosing of study drug
•
Deaths beyond 30 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 (TEAE) of Special Interest
Number and percentage of subjects 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)


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7.1.7.2.
Other Important Safety Topics
Number and percentage of subjects 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)
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 comes 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 
specified in Section 3.7. 
A by-subject listing for laboratory test results will be provided by treatment group, subject ID 
and visit in chronological order for hematology, serum chemistry, and coagulation 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 each laboratory test specified in the 
study protocol as follows:
•
Baseline values 
•
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•
Postbaseline minimum value
•
Change and percentage change from baseline to postbaseline maximum value
•
Change and percentage change from baseline to postbaseline 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 drug plus 70 days or the day before initiation of new anti-AML therapy including 
SCT, whichever comes first, will be summarized by treatment group. If the relevant baseline 
laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame 
specified above will be considered treatment emergent.
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


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•
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 comes 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 laboratory test of interest, with all 
applicable severity grades displayed.
7.2.3.
Shifts Relative to the Baseline Value
Shift tables will be presented by showing change in severity grade from baseline to the worst 
grade postbaseline for hematology, chemistry, and coagulation laboratory tests.
7.3.
Body Weight and Vital Signs
No summary or listing of body weight and vital signs will be provided.
7.4.
Electrocardiogram Results
No summary or listing of electrocardiogram results will be provided.
7.5.
Other Safety Measures
A by-subject listing of pregnancy test report will be provided by subject ID number in ascending 
order.
7.6.
Changes from Protocol-Specified Safety Analyses
The following changes are made from the protocol specified safety analyses:
In TEAE and TE laboratory abnormality definitions, new anticancer therapy is replaced by new 
anti-AML therapy to select qualified AE and laboratory data to summarize.


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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 3.
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 per nominal time point 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. For summary statistics, BLQ values will be treated as 0. 
Sparse PK concentration values that are BLQ will be presented as “BLQ” in the concentration 
data listing. 
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 magrolimab 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 subjects 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 subjects who had negative baseline ADA 
sample and at least one positive post-treatment ADA sample based on subjects 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 subjects 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 subjects who had 
treatment-induced or treatment-boosted ADA based on subjects who had 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 subjects who had persistent ADA based on the ADA 
Incidence Analysis Set.


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Final 
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Treatment-Induced ADA that does not meet the definition of persistent ADA. The propo1iion of 
subjects who had transient ADA is based on the subjects evaluable for ADA incidence. 
Neutralizing antibody (NAb) Incidence: the propo1iion of subjects who had at least one 
positive neutralizing antibody result repo1ied based on the treatment-emergent ADA 
(treatment-induced or treatment-boosted ADA) among the subjects evaluable for ADA 
incidence. 
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PHARMACODYNAMICANALYSES 
Additional details will be provided by the 
biomarker sciences group. 
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10.
REFERENCES
Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised 
recommendations of the International Working Group for Diagnosis, 
Standardization of Response Criteria, Treatment Outcomes, and Reporting 
Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol 
2003;21 (24):4642-9.
Cheson BD, Greenberg PL, Bennett JM, Lowenberg B, Wijermans PW, Nimer SD, et al. Clinical 
application and proposal for modification of the International Working Group 
(IWG) response criteria in myelodysplasia. Blood 2006;108 (2):419-25.
Dohner H, Estey E, Grimwade D, Amadori S, Appelbaum FR, Buchner T, et al. Diagnosis and 
management of AML in adults: 2017 ELN recommendations from an 
international expert panel. Blood 2017;129 (4):424-47.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in 
health-related quality-of-life scores. J Clin Oncol. 1998;16(1):139-144


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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 2.
Disease Response Criteria Based on European LeukemiaNet (ELN) and 
International Working Group (IWG) Criteria


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Appendix 1.
Schedule of Assessments
Appendix Table 1.
Schedule of Assessments – Screeninga
Screening
Assessment
-30 to -1
Informed consenta
X
Demographics
X
Medical and cancer history, including date of most recent RBC and/or platelet transfusion(s)
X
Physical examination
X
Vital signs, height, and weightb
X
Pregnancy testg
X
CBC with differential, platelets, reticulocytes, blasts
X
Serum or plasma chemistry
X
PT, INR, and aPTT (or PTT)
X
Blood phenotyping or genotyping, type, and screen (ABO/Rh), DAT
X
Urinalysis
X
ECOG performance status
X
12 Lead ECG (single)
X
Adverse Eventsc
X
Concomitant medicationsd
X
Eligibility criteria
X
Randomizationa
X
Peripheral blood smear (for blasts)e
X
Bone marrow aspirate for biomarker studiesf
X
Bone marrow biopsy for biomarker studiesf
X
Bone marrow aspirate for response assessment, cytogenetics, and MRD assessmentf
X
Bone marrow aspirate ± biopsy slides or blocks for independent central reviewf
X
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; AE = adverse event; aPTT = activated partial 
thromboplastin time; CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern 
Cooperative Oncology Group; INR = international normalized ratio; MRD = minimal residual disease; PT = prothrombin time; 
PTT = partial thromboplastin time; RBC = red blood cell; Rh = Rhesus factor; SAE = serious adverse event; WBC = white blood cell
a
Screening must be completed prior to 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
Vital signs will be assessed prior to administration of any study treatment. Height will be collected at screening only. 
Weight will be collected at screening and Day 1 of each cycle.
c
All SAEs and any AEs related to protocol-mandated procedures should be collected at screening. Adverse events should be 
recorded at all scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are not 
scheduled. 
d
Prior and concomitant medications should be collected at screening. Concomitant medications should be recorded at all 
scheduled and unscheduled assessment visits, and at all treatment visits, even when other assessments are not scheduled. 


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e
Peripheral blood smear for blasts are to be collected along with bone marrow aspirate/biopsy.
f
A trephine (biopsy) is to be collected if the aspirate sample is dry (not obtainable). If a bone marrow aspirate sample is un-
evaluable, another aspirate sample must be performed within 7 days. At screening, this procedure must be performed prior 
to the first dose of study treatment at the latest. An aspirate sample will be collected for response assessment (eg, blast 
evaluation), cytogenetics, MRD assessment, biomarker studies, and biobanking. When done on the same day, bone marrow 
aspirate samples are to be obtained at the time of bone marrow (trephine) biopsy. Conventional cytogenetics are to be tested 
per institutional standards.
g
A serum pregnancy test will be conducted at screening and urine pregnancy tests will be conducted from Cycle 1 Day 1 
onward. A follicle-stimulating hormone 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. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the screening pregnancy test was performed within 
the 72 hours before study treatment administration.


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Appendix Table 2.
Schedule of Assessments - Treatment Period for magrolimab + venetoclax + azacitidine and placebo + 
venetoclax + azacitidine Regimens
Cycle (28-day Cycles)
1a
2
3+
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
Informed consentd
Demographics
Medical and cancer 
history, including date of 
most recent RBC and/or 
platelet transfusion(s)
Physical examinatione,f
X
X
X
X
X
Vital signs, height, and 
weightf,g
X
X
X
X
X
X
X
X
X
X
X
X
X
Pregnancy testf,h
X
X
X
CBC with differential, 
platelets, reticulocytes, 
blastsf,i
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Haptoglobin and LDHf 
X
X
X
Serum or plasma 
chemistryf 
Xj
Xj
Xj
Xj
X
X
X
X
X
X
PT, INR, and aPTT (or 
PTT)


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Cycle (28-day Cycles)
1a
2
3+
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
Peripheral blood smear 
for general 
morphologye,k
X
X
X
Blood phenotyping or 
genotyping, type, and 
screen (ABO/Rh), DAT
Urinalysis
ECOG performance 
status
12 Lead ECG (single)
Adverse eventsl
Concomitant 
medicationsm
Eligibility criteria
Randomizationc
Efficacy/Biomarkers
PRO assessmentn
X
X
X
Peripheral blood smear 
(for blasts)o
X
X
C4D28, 
C6D28,
then 
Q3C


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Cycle (28-day Cycles)
1a
2
3+
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
Peripheral blood sample 
for biomarker studiesp
X
Xq
X
Xr
X
Xr
C3D28, 
C6D28
Bone marrow aspirate 
for biomarker studiess
X
X
C4D28, 
C12D28
Bone marrow biopsy for 
biomarker studiess
X
C12D28
Bone marrow aspirate 
for response assessment, 
cytogenetics, and MRD 
assessments,t
X
X
C4D28, 
C6D28,
then 
Q3C
Bone marrow aspirate ± 
biopsy slides or blocks 
for independent central 
reviews
X
X
C4D28, 
C6D28,
then 
Q3C
Buccal swabu
X
PK/Immunogenicity
PKv
X
X
X
C3D1, 
C5D1, 
C7D1, 
C10D1, 
C13D1, 
and 
EOT


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Cycle (28-day Cycles)
1a
2
3+
Visit Window (Days)b
None
± 3
± 3
± 3
Cycle Day
1
2
3
4
8
11
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
8
15
22
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
1
15
28
Twice 
Weekly 
Until 
Count 
Recovery 
(Max = 
14 Days)c
Antidrug antibodiesv,w 
X
X
C3D1, 
C5D1, 
C7D1, 
C10D1, 
C13D1, 
and 
EOT
ABO = any of the 4 blood groups A, B, AB, and O composing the ABO system; ADA = antidrug antibodies; AE = adverse event; aPTT = activated partial thromboplastin time; 
CBC = complete blood count; DAT = direct antiglobulin test; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; EOT= end of treatment; 
INR = international normalized ratio; LDH = lactate dehydrogenase; MRD = minimal residual disease; PK = pharmacokinetic(s); PRO = patient-reported outcome; 
PT = prothrombin time; PTT = partial thromboplastin time; Q3C = every 3 cycles; RBC = red blood cell; Rh = Rhesus factor; RO = receptor occupancy; SAE = serious adverse 
event; WBC = white blood cell
a
In cases of magrolimab/placebo repriming/re-escalation following a treatment delay (Protocol Section 5.5.2), follow the safety assessment schedule for Cycle 1, and then the 
assigned cycles. Efficacy, biomarker, PK, and immunogenicity assessments should follow the schedule of the assigned cycle number.
b
Any other visit window specifications for individual assessments should be applied.
c
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 CBD (including prior Day 28 CBC) iis within 3 days of Day 1.
d
Screening must be completed prior to 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.
e
Complete physical examination is to be performed at screening and symptom-directed physical examination is to be performed from Cycle 1 Day 1.
f
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 study treatment administration.
g
Vital signs will be assessed prior to administration of any study treatment. Details are provided in Protocol Section 6.6.4. Height will be collected at screening only. Weight 
will be collected at screening and Day 1 of each cycle.


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h
A serum pregnancy test will be conducted at screening and urine pregnancy tests will be conducted from Cycle 1 Day 1 onward. A follicle-stimulating hormone 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. The Cycle 1 Day 1 pregnancy test does not need to be repeated if the screening pregnancy test was performed within the 72 hours 
before study treatment administration. Additional guidance is provided in Protocol Section 6.6.1.
i
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/placebo dose during 
Cycle 1.
j
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.
k
Peripheral blood smears will be collected predose and assessed locally.
l
All SAEs and any AEs related to protocol-mandated procedures should be collected at screening. Adverse events should be recorded at all scheduled and unscheduled 
assessment visits, and at all treatment visits, even when other assessments are not scheduled.
m
Prior and concomitant medications should be collected at screening. Concomitant medications should be recorded at all scheduled and unscheduled assessment visits, and at 
all treatment visits, even when other assessments are not scheduled.
n
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.
o
Peripheral blood smears for blasts are to be collected along with bone marrow aspirate/biopsy.
p
Samples will be collected predose within 12 hours prior to study treatment administration.
q
Blood samples at Cycle 1 Day 8 to be collected both predose and 1 hour postdose.
r
Starting at Cycle 2 Day 1, peripheral blood samples for biomarker studies on Cycle X Day 1 do not need to be repeated at Day 1 of the cycle if they have been collected 
within the past 7 days.
s
A trephine (biopsy) is to be collected if the aspirate sample is dry (not obtainable). If a bone marrow aspirate sample is not evaluable, another aspirate sample must be 
performed within 7 days. At screening, this procedure must be performed prior to the first dose of study treatment at the latest. An aspirate sample will be collected for 
response assessment (eg, blast evaluation), cytogenetics, MRD assessment, biomarker studies, and biobanking. When done on the same day, bone marrow aspirate samples 
are to be obtained at the time of bone marrow (trephine) biopsy. Conventional cytogenetics are to be tested per institutional standards.
t
Response assessments may be adjusted by ± 1 week for Day 28 of Cycles 1 and 2. After Cycle 2 Day 28, the window is ± 14 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.
u
Single sample will be collected on Day 1 or at any time during the study.
v
Predose PK samples will be collected on the day of magrolimab/placebo dosing, prior to the dosing of azacitidine and magrolimab/placebo. On Cycle 3 Day 1, an additional 
sample for postdose PK sample will be collected at 1 hour (± 15 minutes) after the end of infusion of magrolimab/placebo.
w
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.


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Appendix Table 3.
Schedule of Assessments – Post Treatment
End-of-Treatment 
Visit
Safety 
Follow-up 
Visit/Telephone 
Calla
Safety 
Follow-up 
Visit/Telephone 
Calla
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 Dose
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapy
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapy
Every 2 Months 
(up to 5 years 
from EOT visit) 
Until Death or 
End of Study, 
whichever 
occurs first
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 days
± 14 days
—
Symptom-directed physical 
examination
X
Vital signs 
X
Urine pregnancy testc
Q4W
CBC with differential, platelets, 
reticulocytes, blasts
X
Q12W
Q12W
Serum or plasma chemistry
X
ECOG performance status
X
Adverse eventsd
X
X
X
Concomitant medications
X
X
X
New anti-AML therapy reportinge
X
X
X
X
X
X
PRO assessmentf
X
Peripheral blood smear (for blasts)
X
Q12W
Q12W
Peripheral blood sample for 
biomarker studies
X
Bone marrow aspirate for 
biomarker studies
X
 
 


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End-of-Treatment 
Visit
Safety 
Follow-up 
Visit/Telephone 
Calla
Safety 
Follow-up 
Visit/Telephone 
Calla
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 Dose
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapy
Until Disease 
Progressionb or 
Start of a New 
Anti-AML 
Therapy
Every 2 Months 
(up to 5 years 
from EOT visit) 
Until Death or 
End of Study, 
whichever 
occurs first
Visit Window
± 7 Days
± 7 Days
± 7 Days
± 14 days
± 14 days
—
Bone marrow aspirate for response 
assessment, and cytogeneticsg,h
X
Q12W
Q12W
Pharmacokinetics
X
Antidrug antibodies 
X
Survival follow-up
X
AE = adverse event; CBC = complete blood count; CR = complete remission; CRh = CR with partial hematologic recovery; CRi = CR with incomplete hematologic recovery; 
ECOG = Eastern Cooperative Oncology Group; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire; EOT = end of 
treatment; MLFS = morphologic leukemia-free state; MRD = minimal residual disease; PGIS/PGIC = Patient Global Impression of Severity/Patient Global Impression of Change; 
Q4W = every 4 weeks; Q12W = every 12 weeks; SAE = serious adverse event; SCT = stem cell transplantation
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
Disease progression includes relapse after CR/CRi/CRh or disease progression after partial remission, stable disease, or MLFS.
c
Pregnancy testing will be continued monthly up to 3 months after the end of treatment per the duration of contraception requirement as discussed in Protocol Appendix 5. 
Testing during survival follow-up may be done at home and the result self-reported by the patient.
d
Report all AEs through the Safety Follow-up Visit/Call, and any treatment-related SAEs thereafter.
e
Collect data for the first new anti-AML therapy following the last dose of study treatment or following SCT.
f
EORTC QLQ-C30 and EQ-5D-5L questionnaires should be performed prior to PGIS/PGIC.
g
Response assessment at EOT visit not required if performed within the last 30 days or documented disease progression/relapse or start of new anti-AML therapy, whichever 
occurs first. (SCT and maintenance therapy are not considered new anti-AML therapy.)
h
Conventional cytogenetic testing (per institutional standards) is required for all patients.


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Appendix 2.
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 European 
LeukemiaNet (ELN) 2017 recommendations for AML with modifications {Dohner 2017} 
(Appendix Table 4). 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).
Cytogenetic CR (cCR) will be assessed by 2003 IWG criteria as CR with normal cytogenetics 
(Appendix Table 5) {Cheson 2003}.
Hematologic improvement will be assessed by 2006 IWG criteria {Cheson 2006} to compare 
with disease response assessed by 2017 ELN criteria (Appendix Table 6) {Dohner 2017}.
The date of the bone marrow assessment should be used as the date of response assessment. 
Complete blood count 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 PD 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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Appendix Table 4.
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  109/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  10
9/L
> 100  10
9/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] nontransfused); or 
> 50% increase in peripheral blasts (WBC  % 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 hematologic recovery; CRMRD- = complete remission 
without minimal residual disease; CRMRD+/unk = complete remission with MRD Positive/MRD Unknown; 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}
Appendix Table 5.
Additional Response Definitions Used in This Study (2003 IWG 
Criteria)
Definitions
Response Criteria
Neutrophils
Platelets
Bone Marrow Blasts
Other
Cytogenetic CR 
(cCR)
> 1.0  10
9/L
> 100  10
9/L
< 5%
Cytogenetics 
normal and no 
evidence of 
extramedullary 
disease
Treatment Failurea
Failure to achieve CR within 6 cycles of treatment
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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Appendix Table 6.
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 Hematological 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}


GS-US-590-6154 Final Analysis
ELECTRONIC SIGNATURES
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yyyy hh:mm:ss)
Biostatistics eSigned
10-May-2024
15:30:08
Global Development
Lead (GDL) eSigned
10-May-2024
15:57:04
PPD
PPD