Conditions: Waldenström's Macroglobulinemia (WM)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

Brief summary:
This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.

Detailed description:

Arms:
arm 1: Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity

Interventions: intervention 1: Zanubrutinib
Intervention descriptions: intervention 1: Oral administration using 80 mg capsules

Protocol document:
Prot_000.pdf: 
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Page 210


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Page 211


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Page 297

SAP_001.pdf: 
BeiGene (Beijing) Co., Ltd
BGB-3111-210
(Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 1 of 38
CONFIDENTIAL
STATISTICAL ANALYSIS PLAN
Study Protocol 
Number:
BGB-3111-210
Study Protocol 
Title:
A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton’s Tyrosine 
Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects with Relapsed/
Refractory Waldenström’s Macroglobulinemia (WM)
Date:
15-May-2019
Version:
2.0
Page 40
1&7


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 2 of 38
CONFIDENTIAL
SIGNATURE PAGE
Author:
BeiGene (Beijing) Co., Ltd.
Approval
BeiGene USA, Inc.
BeiGene USA, Inc.
Page 41


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 3 of 38
CONFIDENTIAL
TABLE OF CONTENTS
1 
INTRODUCTION
7 
2 
STUDY OVERVIEW
7 
3 
STUDY OBJECTIVES
9 
3.1 
Primary Objectives
9 
3.2 
Secondary Objectives
9 
3.3 
Exploratory Objectives
10 
4 
STUDY ENDPOINTS
10 
4.1 
Primary Endpoint
11 
4.2 
Secondary Endpoints
11 
4.3 
Exploratory Endpoints
12 
5 
SAMPLE SIZE CONSIDERATIONS
13 
6 
STATISTICAL METHODS
13 
6.1 
Analysis Sets
13 
6.2 
Data Analysis General Considerations
14 
6.2.1 
Definitions and Computations
14 
6.2.2 
Conventions
14 
6.2.3 
Handling of Missing Data
15 
6.2.4 
Adjustment for Covariates
15 
6.2.5 
Multiplicity Adjustment
15 
6.2.6 
Data Integrity
15 
6.3 
Patient Characteristics
16 
6.3.1 
Patient Disposition
16 
6.3.2 
Protocol Deviations
16 
6.3.3 
Demographic and Other Baseline Characteristics
16 
6.3.4 
Disease History and Characteristics
16 
6.3.5 
Prior Anti-Cancer Therapies
17 
6.3.6 
Prior and Concomitant Medications
17 
6.3.7 
Medical History
17 
6.4 
Efficacy Analysis
17 
6.4.1 
Primary Efficacy Endpoint
17 
6.4.2 
Secondary Efficacy Endpoints
18 
6.4.2.1 
Response rate
18 
6.4.2.2 
Progression Free Survival (PFS)
18 
6.4.2.3 
Duration of response
19 
6.4.2.4 
Time to response
20 
6.4.2.5 
Resolution of treatment precipitating symptoms
20 
6.4.2.6 
Anti-lymphoma effect
21 
6.4.3 
Exploratory Efficacy Endpoints
22 
6.4.3.1 
Overall Survival
22 
6.4.3.2 
VGPR or CR rate
22 
6.4.3.3 
Changes of lymph node size from baseline
22 
Page 42


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 4 of 38
CONFIDENTIAL
6.4.3.4 
Change of spleen size from baseline
22 
6.4.3.5 
Change of IgM level from baseline
22 
6.4.3.6 
Change of hemoglobin from Baseline
22 
6.4.3.7 
Other exploratory endpoints
23 
6.4.4 
Sensitivity Analyses
23 
6.4.5 
Subgroup Analyses
23 
6.4.6 
Biomarker/Pharmacodynamic Endpoints
23 
6.5 
Safety Analyses
24 
6.5.1 
Extent of Exposure
24 
6.5.2 
Adverse Events
25 
6.5.3 
Laboratory Values
27 
6.5.4 
Vital Signs
28 
6.5.5 
Electrocardiograms (ECG)
28 
6.5.6 
ECOG
28 
6.6 
Other Analyses
28 
7 
INTERIM ANALYSIS
29 
8 
CHANGES IN THE PLANNED ANALYSIS
29 
9 
REFERENCES
30 
10 
APPENDIX
31 
Page 43


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 5 of 38
CONFIDENTIAL
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS
Abbreviation
Term
AEs
adverse events
AESI
AE of special interest
ALT
alanine aminotransferase
ALP
alkaline phosphatase
aPTT
Activated Partial Thromboplastin Time
AST
aspartate aminotransferase
ATC
Anatomic Therapeutic Chemical
BID
twice a day
BOR
best overall response
BTK
Bruton’s tyrosine kinase
CI
confidence interval
CR
complete response
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
DOMR
duration of major response
DOR
duration of response
DOV
date of visit
EAIR
exposure-adjusted incidence rate
ECG
electrocardiogram
ECOG
Eastern Cooperative Oncology Group
eCRF
electronic case report form
EOT
end of treatment
FDA
Food and Drug Administration
HBcAb
hepatitis B core antibody
HBsAb
hepatitis B surface antibody
HCV
hepatitis C virus
INR
international normalized ratio
IPSS
International Prognostic Scoring System
IRC
independent review committee
IWWM
International Workshop for Waldenström's Macroglobulinemia
MedDRA
Medical Dictionary for Regulatory Activities
Page 44


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 6 of 38
CONFIDENTIAL
MRR
major response rate
NDA
new drug application
ORR
overall response rate
OS
overall survival
PD
progressive disease
PFS
progression-free survival
PP
per-protocol
PR
partial response
PT
preferred term 
R/R
relapsed or refractory
SAEs
serious adverse events
SAP
statistical analysis plan
SMC
safety monitoring committee
SOC
system organ class
SPD
sum of products of diameters
TBL
total bilirubin
TEAEs
treatment emergent adverse events
TTR
time to response
ULN
upper limit of normal
VGPR
very good partial response
WHO DD
World Health Organization Drug Dictionary
WM
Waldenström’s macroglobulinemia
Page 45


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 7 of 38
CONFIDENTIAL
1
INTRODUCTION
This statistical analysis plan (SAP) describes the detailed plan for data analysis in evaluation of 
safety and efficacy of zanubrutinib (BGB-3111) for BGB-3111-210. This document is based on 
the protocol version 3.0 dated 30-Mar-2018.
The analysis details for biomarker analyses are not described within this SAP. Any changes made
to the planned analyses that are in the protocol will be identified and documented in Clinical Study 
Report.
The SAP version 2.0 is an amendment to the initial version of the SAP (version1.0 dated Sep-19-
2018).
2
STUDY OVERVIEW
This is a single-arm, open-label, multi-center Phase 2 study in patients with Waldenström’s 
macroglobulinemia (WM) requiring therapy using the consensus panel criteria updated at the 6th 
International Workshop for Waldenström's Macroglobulinemia (IWWM) (Owen et al 2013;
NCCN Guidance Insights, 2012). The study is composed of an initial screening phase (up to 28 
days), a single-arm treatment phase, and a follow-up phase.
Approximately 40 patients will be enrolled. The primary efficacy analysis will be conducted at up
to 12 months after the last patient receives the first dose of study drug. Tumor response will be 
assessed by independent review committee (IRC) according to the response criteria updated at the 
6th IWWM (Owen et al 2013; NCCN Guidance Insights, 2012). IgM level will be measured at 
screening, on Day 1 of every cycle for the first 52 weeks, and every 3 cycles thereafter. Assessment 
by computed tomography (CT) scan will occur every 12 weeks for the first 48 weeks, and then 
every 24 weeks until disease progression. Bone marrow will be assessed by aspirate and biopsy at 
screening, every 24 weeks, at time of suspected complete response (CR) and as clinically indicated.
All patients will be followed for adverse events AEs) for 30 ± 7 additional days after the last 
dose of study drug. All treatment-related AEs and serious adverse events (SAEs) will be 
followed until resolution or stabilization.
Screening phase: Screening evaluations will be performed within 28 days prior to the first dose 
of study drug. Patients will sign the informed consent form prior to any screening evaluations. 
Please refer to Table 3 in the protocol for details on screening procedures. Screening evaluations 
can be repeated within the screening period. 
Treatment phase: Patients will receive the first dose of zanubrutinib at Cycle 1 Day 1. All 
patients will be treated with 160 mg, administered orally, twice a day (BID), about 12± 2 hours
apart, and will continue to be treated until disease progression, unacceptable toxicity, death, 
Page 46


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 8 of 38
CONFIDENTIAL
withdrawal of consent, or the study is terminated by the sponsor for final analysis. A treatment 
cycle is 28 days.  
Follow-up phase: Patients will return 30 ± 7 days after the last dose of study drug for safety 
follow-up visit(s). Assessments to be performed are presented in Table 3 in the protocol.
Efficacy evaluations will continue until documented disease progression. If a patient
discontinues study drug due to reasons other than disease progression, efficacy evaluations will 
continue until patient exhibits first progression, withdrawal of consent, death, lost to follow-up,
or study termination by sponsor, whichever occurs first.
Survival Follow-up phase: After attending the last visit, the patient/guardian will be contacted 
by telephone every 3 months for follow up, and this will continue up until the patient withdraws 
informed consent, lost to follow up, death, or final data cut off.
Page 47


BeiGene (Beijing) Co., Ltd
                       BGB-3111-210
              (Statistical Analysis Plan)
Version 2.0: 15-May-2019
Page 9 of 38
CONFIDENTIAL
Figure 1
Schema for Study BGB-3111-210
3
STUDY OBJECTIVES
3.1
PRIMARY OBJECTIVES  
The primary objective of the study is to determine the efficacy of zanubrutinib in Chinese 
patients with relapsed or refractory (R/R) WM as measured by the major response rate (MRR)
defined as the proportion of patients who achieves complete response (CR) + very good partial 
response (VGPR) + partial response (PR), to be assessed by an IRC according to an adaptation of 
the response criteria updated at the 6th IWWM (Owen et al 2013; NCCN Guidance Insights, 
2012).
3.2
SECONDARY OBJECTIVES  
x
To determine the efficacy of zanubrutinib in patients with R/R WM as measured by 
progression-free survival (PFS)
zanubrutinib
160mg BID
28-day cycles
until progressive disease (PD) or intolerable toxicity
Discontinue
due to PD
•
Safety Follow-up visit (30 ± 7 
days after EOT
•
Survival Follow-up every 3 
months
R/R Waldenström’s Macroglobulinemia (WM) Requiring Therapy
Diagnosis must be confirmed by Central Pathologic Review before 
initiation of therapy
•
Safety Follow-up visit (30 ± 7 
days after EOT
•
Continue efficacy evaluations 
(tumor assessments) until PD
•
Survival Follow-up every 3 
months
Discontinue
due to reason other than PD
End of Treatment (EOT)
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x
To determine the efficacy of zanubrutinibin patients with R/R WM as measured by 
overall response rate (ORR)
x
To determine the efficacy of zanubrutinib in patients with R/R WM as measured by 
duration of major response DOMR
x
To characterize the clinical benefit of zanubrutinib in patients with WM as determined by 
the frequency of resolution of treatment-precipitating symptoms
x
To characterize the magnitude of improvement in bone marrow involvement with 
lymphoplasmacytoid lymphocytes in patients with R/R WM treated with zanubrutinib, as 
measured by the maximum decrease in percentage of lymphoplasmacytoid lymphocytes 
by bone marrow biopsy
x
To determine the safety and tolerability of zanubrutinib in patients with R/R WM as 
determined by the frequency and severity of AEs according to Common Terminology 
Criteria for Adverse Events (CTCAE) v4.03, and the rate of discontinuation of treatment, 
dose reduction and dose interruption of study drug due to AEs.
3.3
EXPLORATORY OBJECTIVES 
x
To evaluate overall survival (OS) in patients with WM 
x
To determine the CR plus VGPR rates in WM patients with different genotype (MYD88
L265P mutation, MYD88 L265P mutation/CXCR4 WHIM, MYD88 L265P 
mutation/CXCR4 wild-type, MYD88 wild-type).
x
To evaluate drug resistance mechanisms through comparison of bone marrow aspiration 
at screening, and on relapse
4
STUDY ENDPOINTS
Response of WM patients will have 2 types of assessment by IRC and 1 type of assessment by 
investigator, respectively:
x
overall combined assessment by IRC
x
overall IgM assessment by IRC
x
overall combined assessment by investigator 
All efficacy endpoints will be analyzed in the revised safety analysis set as defined in Section 
6.1.
The differences between these 2 types of assessment by IRC are summarized in Appendix B.
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4.1
PRIMARY ENDPOINT 
The primary endpoint of the study is the MRR, defined as the proportion of patients who achieve 
CR + VGPR + PR, to be assessed by an IRC according to an adaptation of the response criteria 
updated at the 6th IWWM (Owen et al 2013; NCCN Guidance Insights, 2012) (hereafter referred 
as overall combined assessment by IRC).
For regulatory submission, response assessment  based on IgM alone (i.e. overall IgM 
assessment by IRC) may be used in the primary analysis, depending on the discussion with 
regulatory agency in pre-NDA meeting.
4.2
SECONDARY ENDPOINTS 
Efficacy:
x
PFS: defined as time from first dose of zanubrutinib until first documentation of 
progression or death, whichever comes first.
o
Per overall combined assessment by IRC
o
Per overall IgM assessment by IRC
o
Per overall combined assessment by investigator 
x
ORR: defined as the proportion of patients who achieve minor, partial, very good partial, 
and complete response.
o
Per overall combined assessment by IRC
o
Per overall IgM assessment by IRC
o
Per overall combined assessment by investigator 
x
MRR: defined as the proportion of patients who achieve PR, VGPR, or CR
o
Per overall IgM assessment by IRC
o
Per overall combined assessment by investigator
x
Rate of VGPR or CR: defined as the proportion of patients who achieve VGPR or CR
o
Per overall combined assessment by IRC
o
Per overall IgM assessment by IRC
x
Duration of response (DOR): defined as the time from the date of the earliest qualifying 
response to the date of PD or death (whichever occurs earlier).
-
Duration of overall response 
o
Per overall IgM assessment by IRC
-
Duration of major response 
o
Per overall combined assessment by IRC
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o
Per overall IgM assessment by IRC
o
Per overall combined assessment by investigator
-
Duration of VGPR or CR 
o
Per overall IgM assessment by IRC
x
Time to response (TTR): defined as time from the first dose of the study drug to the date 
of the earliest qualifying response.
-
Time to overall response
o
Per overall IgM assessment by IRC
-
Time to major response 
o
Per overall combined assessment by IRC
o
Per overall IgM assessment by IRC
o
Per overall combined assessment by investigator
-
Time to VGPR or CR
o
Per overall IgM assessment by IRC
x
Resolution of treatment precipitating symptoms, defined as absence of symptoms (see
Table 2)
x
Anti-lymphoma effect is defined as any reduction in bone marrow involvement by 
lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly 
by CT scan by IRC. Lymphadenopathy is defined as any node with longest diameter 
(LDi) > 1.5 cm and splenomegaly is defined as vertical spleen length > 13 cm.
Safety:
To evaluate the safety and tolerability of zanubrutinib as defined by:
x
The incidence and severity of treatment emergent adverse events (TEAEs), SAEs and 
treatment-related AEs according to CTCAE v4.03
x
The incidence, severity, and causation of AEs leading to study drug discontinuation, dose 
reduction and dose interruption
4.3
EXPLORATORY ENDPOINTS 
x
OS defined as the time from the date of the first dose of zanubrutinib until date of death 
from any cause
x
CR plus VGPR rates in 4 subgroups: patients with MYD88 L265P mutation, MYD88
L265P mutation/CXCR4 WHIM, MYD88 L265P mutation/CXCR4 wild-type, MYD88
wild-type.
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x
Identification of potential drug resistance biomarkers and mechanisms: paired bone 
marrow aspiration (at screening and at relapse) will be used to identify potential 
biomarkers and mechanisms.
x
Rate of VGPR or CR
o
overall combined assessment by investigator
x
Duration of overall response and time to overall response
o
overall combined assessment by IRC
o
overall combined assessment by investigator 
x
Duration of VGPR or CR and time to VGPR or CR
o
per overall combined assessment by IRC
o
per overall combined assessment by investigator  
x
Change of IgM level from baseline
x
Change of lymph node size from baseline
x
Change of spleen size from baseline
x
Change of hemoglobin from baseline
5
SAMPLE SIZE CONSIDERATIONS
The sample size calculation of 40 patients was based on the precision of an MRR estimate and 
the power of the comparison to the historical rate, under assumed MRR of 60% in the study as 
compared to 30% in the historical control (95% CI is 43.3%, 75.1%). Using a binomial exact 
test, the power is >0.969 with 40 patients to demonstrate statistical significance at a 1-sided
alpha of 0.025 under above assumption.
If the observed MRR is 60%, its 95% exact CI from 40 patients will be (43.3%, 75.1%).
6
STATISTICAL METHODS
6.1
ANALYSIS SETS 
The safety analysis set (SA) includes all patients who received at least one dose of zanubrutinib.
It will be the primary analysis set for the safety analyses.
The revised safety analysis set includes patients with pathologically confirmed WM and with 
baseline IgM (or M-protein) ≥5 g/L among those in the safety analysis set. The analysis set is the 
primary efficacy evaluable analysis set.
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The Per-protocol (PP) Analysis Set includes patients in the revised safety set without important 
protocol deviations. Criteria for exclusion from the PP analysis set will be determined and 
documented before the database lock for the primary analysis. This analysis set may be used as a 
sensitivity analysis of the efficacy endpoints as necessary.
A summary of analysis sets will provide the number and percentage of patients in each analysis 
set.
6.2
DATA ANALYSIS GENERAL CONSIDERATIONS 
6.2.1
Definitions and Computations
Study treatment (study drug) for this study is zanubrutinib.
Study day: Study day will be calculated in reference to the date of the first dose of study drug.  
For assessments conducted on or after the date of the first dose of study drug, study day will be
calculated as (assessment date – date of first dose of study drug + 1).  For assessments conducted 
before the date of the first dose of study drug, study day is calculated as (assessment date – date 
of first dose of study drug). There is no study day 0.
In the situation where the event date is partial or missing, the date will appear partial or missing 
in the listings; Study day and any corresponding durations will be presented based on the 
imputations specified in Appendix A.
Treatment duration: The treatment duration will be calculated as (date of the last dose of study 
drug – date of first dose of study drug + 1).
Baseline: Unless otherwise specified, a baseline value is defined as the last non-missing value 
collected before the first dose of study drug.
All calculations and analyses will be conducted using SAS version 9.4 or higher.
6.2.2
Conventions
Unless otherwise specified, the following conventions will be applied to all analyses:
x
P-values will be rounded to 4 decimal places.  P-values that round to 0.0000 will be 
presented as ‘< 0.0001’ and p-values that round to 1.000 will be presented as ‘> 0.9999’.  
x
Missing efficacy or safety data will not be imputed unless otherwise specified.
x
For by-visit observed data analyses, percentages will be calculated based on the number 
of patients with non-missing data as the denominator, unless otherwise specified.
x
For continuous endpoints, summary statistics will include n, mean, standard deviation, 
median, Q1, Q3 and range (minimum and maximum). The minimum and maximum will 
be reported to the same number of decimal places as the raw data recorded in the 
database. The mean, median, Q1 and Q3 will be reported to one more decimal place than 
the raw data recorded in the database. The standard deviation will be reported to two 
more decimal places than the raw data recorded in the database. In general, the maximum 
number of decimal places reported shall be four for any summary statistic.
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x
For discrete endpoints, summary statistics will include frequencies and percentages. 
Percentages will be presented to one decimal place. 
x
Data collected at an unscheduled visit will not be included in by visit analysis. For by 
visit analysis, if multiple assessments happened in the same visit window in table 3 of the 
protocol, the closest assessment to the planned date/time (if collected) will be used in 
analysis. If multiple records have the same distance to the planned date/time, the last non-
missing assessment will be used.
6.2.3
Handling of Missing Data
Missing data will not be imputed unless otherwise specified elsewhere in the SAP. Missing dates 
or 
partially 
missing 
dates 
will 
be 
imputed 
conservatively 
for 
prior/concomitant 
medications/procedures, subsequent anti-cancer therapies, adverse events and deaths as provided 
in Appendix A for analyses that require the date values.
When summarizing categorical variables, patients with missing data are generally included in the 
denominator to calculate percentages unless otherwise specified. When needed, the category of 
“Missing” is created and the number of patients with missing data is presented.
When summarizing continuous variables, patients with missing data are not included in 
calculations unless otherwise specified.
No imputation of AE grades will be performed. TEAEs with missing CTCAE grade will only be 
summarized in the all-grades column.
If the assessment of the relationship of an AE to study treatments is missing, then the AE is 
assumed to be related to the study treatment in the safety analysis summary. No imputation will
be done in the AE listings.
By-visit summary of variables with missing data will use only non-missing data, not imputed one, 
unless otherwise specified. Unscheduled visits will not be included in by-visit summaries.  
6.2.4
Adjustment for Covariates
Not applicable.
6.2.5
Multiplicity Adjustment
Not applicable. 
6.2.6
Data Integrity
Before any pre-specified statistical analysis begins, the integrity of the data should be reviewed 
to assure fit-for-purpose. The data set for analysis should be an accurate and complete 
representation of the patients' relevant outcomes from the clinical database. All essential data 
should be complete and reviewed up to a pre-specified cutoff date. Consistency checks and 
appropriate source data verification should be completed according to the final data extraction 
plan.
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6.3
PATIENT CHARACTERISTICS
6.3.1
Patient Disposition
The following patient disposition information will be summarized for all enrolled patients:
x
Number of patients enrolled (screened and inclusion/exclusion criteria met)
x
Number of patients enrolled but not treated
x
Number of treated patients
x
Number (%) of treated patients who discontinued treatment
x
Reason(s) for treatment discontinuation
x
Number (%) of treated patients who discontinued study
x
Reason(s) for study discontinuation
The number (%) of patients still receiving treatment and still in the study at data cut-off will also 
be summarized.
Study follow-up time will be defined as the time from first dose date to the death date or end of 
study date (whichever occurs earlier) for patients discontinued from study, or the database cutoff 
date for ongoing patients. Study follow-up time will be estimated by median and range.
6.3.2
Protocol Deviations
The CRO (Parexel) will assess potential protocol deviations as potential minor or potential major 
protocol deviations according to the protocol deviation specification in the study and review them 
with the sponsor (BeiGene) medical monitor and statistician to determine the major protocol 
deviations. The final determination of important protocol deviations from major protocol 
deviations will be made by BeiGene team. Important protocol deviations will be summarized by 
deviation category for the safety analysis set. Both major protocol deviations and important 
protocol deviation will be listed.
6.3.3
Demographic and Other Baseline Characteristics
Demographic and other baseline characteristics will be summarized in the safety analysis set using 
descriptive statistics. Continuous variables include age, weight, height, body mass index,
categorical variables include gender, race, age group (< 65 years vs. ≥ 65
years), 
ECOG-performance status, viral serology (including HBcAb, HBsAb and HCV antibody). A
listing of demographic and other baseline characteristics will be provided.
6.3.4
Disease History and Characteristics
Disease history and baseline disease characteristic, as recorded on the eCRF, will be summarized
by descriptive statistics for the safety analysis set. Disease characteristics include time since initial
diagnosis of WM to first dose, prognostic group at initial diagnosis and study entry, WM 
International Prognostic Scoring System (IPSS) score at study entry (low, intermediate, high),
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Genotype status for MYD88 (L265P mutation, wild type), CXCR4 (WHIM mutation, wild-type),
extramedullary disease (yes vs no), time from last disease progression to first dose, indications for 
treatment (see Table 2), cytopenia, baseline bone marrow lymphoplasmacytic cell involvement 
(lower limit ≥50% vs. higher limit < 50%), serum β2 microglobulin (≤ 3 mg/L vs. > 3 mg/L),
hemoglobin, absolute neutrophil count, serum immunoglobulin (IgM, IgA and IgG), SPEP, serum 
immunofixation. A listing of disease history will be provided.
6.3.5
Prior Anti-Cancer Therapies 
The number of prior systemic regimens, prior systemic therapies, best response to last systemic
regimen, duration of last regimen (i.e. most recent therapy), time (months) from the end of last
systemic regimen to first dose of study drug, number (%) of patients with prior radiotherapy will 
be summarized and listed for the safety analysis set.
The therapies and surgeries with the same sequence/regimen number are counted as one prior 
therapy/surgery.    
6.3.6
Prior and Concomitant Medications
Prior and concomitant medications will be coded using the World Health Organization Drug 
Dictionary (WHO DD) drug codes version March 2017 or later and will be further classified to the
appropriate Anatomical Therapeutic Chemical (ATC) code. 
Prior medications are defined as medications that started before the first dose date. Concomitant 
medications are defined as medications that (1) started before the first dose of study drug and were 
continuing at the time of the first dose of study drug, or (2) started on or after the date of the first
dose of study drug up to 30 days after the patient’s last dose or initiation of a new anti-cancer 
therapy. For the purpose of determining if a medication should be noted as a concomitant 
medication, the imputation rules stated in the Appendix A will be used.  
The number (%) of patients reporting prior and concomitant medications will be summarized by 
ATC medication class Level 2 and WHO DD preferred term (PT) in the safety analysis set. A
listing of prior and concomitant medications will be provided.
6.3.7
Medical History
Medical History will be coded using Medical Dictionary for Regulatory Activities (MedDRA)
(version 20.0 or higher). The number (%) of patients reporting a history of any medical condition, 
as recorded on the eCRF, will be summarized by MedDRA system organ class (SOC) and preferred 
term (PT) based on the safety analysis set. A listing of medical history will be provided.
6.4
EFFICACY ANALYSIS
All efficacy analyses will be based on the revised safety analysis set.
6.4.1
Primary Efficacy Endpoint
Major response rate per overall combined assessment by IRC
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The primary endpoint of the study is MRR, defined as the proportion of patients who achieved
Best Overall Response (BOR) of CR or VGPR or PR assessed by an IRC according to an 
adaptation of the response criteria updated at the 6th IWWM (Owen et al 2013; NCCN Guidance 
Insights 2012).
A point estimate and a 2-sided Clopper-Pearson 95% confident interval (CI) of MRR will be 
provided. A binomial exact test will be performed to test against the null hypothesis H0: MRR=0.30
using the significant level of 0.025 (1-sided). 
A patient’s best overall response (BOR) is the best response recorded throughout the study (prior 
to data cutoff). Responses recorded after initiation of new anti-cancer treatment will not be 
considered for best overall response. Response rate is a crude proportion of patients with best 
overall responses in corresponding response categories. Patients without postbaseline disease 
assessment (due to any reason) will be considered as non-responders. The number and proportion
of patients who achieved each BOR category will be calculated.
The primary efficacy analysis will be conducted at up to 12 months after the last patient receives 
the first dose of study drug. Subsequent analyses will be performed when mature secondary 
efficacy endpoints are available.
For regulatory submission, response assessment based on IgM alone (i.e. overall IgM assessment 
by IRC) may be used as the primary analysis, depending on the discussion with regulatory agency 
in the pre-NDA meeting.
6.4.2
Secondary Efficacy Endpoints
6.4.2.1
Response rate
The ORR is defined as the proportion of patients whose BOR meet the overall response.
The VGPR or CR rate is defined as the proportion of patients whose BOR meet the VGPR or CR.
A point estimate and a 2-sided Clopper-Pearson 95% CI will be provided for ORR and VGPR or 
CR, respectively.
6.4.2.2
Progression Free Survival (PFS)
PFS is defined as the time (in months) from the first dose date of study drug to the date of first 
documentation of disease progression or death of any cause, whichever occurs first:
PFS = (The earlier of disease progression or death date – the date of first study dose +1)/ 30.4375
PFS will be right-censored for patients who met one of the following conditions: 1) no baseline 
disease assessments; 2) starting a new anti-cancer therapy before PD or death; 3) death or PD 
immediately after more than 6 months since last disease assessment (or 12 months if a patient is 
on the response assessment schedule of every 24 weeks); and 4) alive without documentation of 
disease progression. For such patients, the primary analysis of PFS will be right-censored 
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according to the convention described in Table 1 which is based on the May 2007 FDA Guidance 
for Industry: “Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”
(www.fda.gov/cder/guidance/7478fnl.htm) (FDA 2007).
Only those procedures with valid assessment results will be used in determination of PFS.
Table 1
Date of Progression or Censoring for Progression Free Survival
Situation
Date of Progression Event
Outcome
1. Death or PD between planned 
disease assessments
Date of death or first disease assessment 
showing PD, whichever occurs first
Event
2. Death before first PD assessment 
or between adequate assessment 
visits
Date of death
Event
3. No baseline disease assessments
Date of first dose
Censored
4. New anti-cancer treatment started 
before PD or death
Date of last disease assessment without 
PD prior to start of a new anti-cancer 
treatment
Censored
5. Death or PD more than 6 months
>@
after last disease assessment 
Date of last disease assessment that is 
before death or PD 
Censored
6. Alive and without PD 
Date of last disease assessment visit 
Censored
[1] Or 12 months if a patient is on the assessment schedule of every 24 weeks.
The distribution of PFS, including median and PFS rate at selected timepoints such as 6, 9, and 12 
months, will be estimated using the Kaplan-Meier method. The 95% confidence interval for 
median and other quartiles of PFS will be generated by using Brookmeyer method (Brookmeyer 
and Crowley 1982; Klein and Moeschberger 1997), whereas the 95% confidence interval for PFS 
rate at landmark times will be generated by using Greenwood formula (Greenwood 1926;
Kalbfleisch and Prentice1980). Duration of follow-up for PFS will be estimated by reverse Kaplan-
Meier method (Schemper and Smith 1996). Kaplan-Meier curves for PFS will be also generated.
A listing will be provided for the information of patient PFS, date of progression or censor, and 
reason.
6.4.2.3
Duration of response
Duration of response (DOR) for responders (those who satisfy the criteria for overall response,
major response, VGPR or CR, respectively) is defined as time (in months) from the date of the 
earliest qualifying response to the date of PD or death for any cause (whichever occurs earlier).
The analysis methods, including censoring rules, will be the same as those for PFS. Only 
responders are included in the analysis.
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6.4.2.4
Time to response
TTR for responders (those who satisfy the criteria for overall response, major response, VGPR or 
CR, respectively) is defined as time (in months) from the first dose of the study drug to the date of 
the earliest qualifying response. TTR will be summarized by sample statistics such as mean, 
median and range for responders only.
6.4.2.5
Resolution of treatment precipitating symptoms 
The number (%) of patients who achieve resolution of baseline signs or symptoms that 
precipitated the need for treatment (see Table 2) will be summarized.
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Table 2
Indications for initiation of therapy in patients with WMa
Clinical indications for initiation of therapy 
Recurrent fever, night sweats, weight loss 
Fatigue
Hyperviscosity
Lymphadenopathy which is either symptomatic or bulky (≥5 cm in maximum diameter) 
Symptomatic hepatomegaly and/or splenomegaly
Symptomatic organomegaly and/or organ or tissue infiltration 
Peripheral neuropathy due to WM
Laboratory indications for initiation of therapy 
Symptomatic cryoglobulinemia 
Cold agglutinin anemia 
Immunehemolytic anemia and/or thrombocytopenia 
Nephropathy related to WM
Amyloidosis related to WM 
Hemoglobin İ10 g/dL 
Platelet count ≤100 × 109/L 
a Seventh IWWM (Dimopoulos et al, 2014)
6.4.2.6
Anti-lymphoma effect
Any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or any 
reduction in size of lymphadenopathy and/or any reduction in size of splenomegaly by CT scan 
will be summarized descriptively with incidence and percentage. Lymphadenopathy is defined as 
any node with longest diameter (LDi) > 1.5 cm and splenomegaly is defined as vertical spleen 
length > 13 cm.
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6.4.3
Exploratory Efficacy Endpoints
6.4.3.1
Overall Survival
Overall survival (OS) is defined as the time (in months) from the date of first dose to death due 
to any cause. Patients who remained alive before data cutoff or discontinuation of the study
(discontinued study due to reasons other than “Death”) will be censored at the last date the 
patient was known to be alive on or prior to data cutoff. The analysis methods for OS will be
same as those for PFS.
6.4.3.2
VGPR or CR rate
VGPR or CR rate will be determined in patients with MYD88 L265P mutation, MYD88 L265P 
mutation/CXCR4 WHIM, MYD88 L265P mutation/CXCR4 wild-type, MYD88 wild-type as the
proportion of patients who achieve CR or VGPR. The analysis methods for VGPR or CR rate
will be same as those for the rate in Section 6.4.2.1.
6.4.3.3
Changes of lymph node size from baseline
Change of lymph node size from baseline will be summarized for patients with baseline 
lymphadenopathy by maximum reduction in sum of products of diameters (SPD). Summary of 
maximum reduction per patient will be provided using descriptive statistics and using a waterfall 
plot. Lesions with diameter too small to measure or not reported or less than 0.5 cm will be 
imputed as 0.5 cm in the SPD calculation. Only nodal target lesions will be included in the SPD 
calculation for this endpoint. The measurements by IRC’s radiology assessment will be used in 
the calculation.
6.4.3.4
Change of spleen size from baseline
Change of spleen size from baseline will be summarized for patients with baseline splenomegaly 
by maximum reduction in cranial to caudal length of spleen.  Summary of maximum reduction 
per patient will be provided using descriptive statistics and using a waterfall plot. The 
measurements by IRC’s radiology assessment will be used in the calculation. 
6.4.3.5
Change of IgM level from baseline
Change of IgM level from baseline will be summarized using descriptive statistics such as mean, 
median and range by visit and using a box-whisker plot. The summary of maximum reduction 
per patient will also be provided using descriptive statistics and using a waterfall plot. If the
baseline IgM is not applicable, the available M-Protein will be used throughout the study and 
summarized together with IgM values for this endpoint.
6.4.3.6
Change of hemoglobin from Baseline
Change of hemoglobin from baseline will be summarized by visit using descriptive statistics and 
using a box-whisker plot. The analysis will be repeated for the overall revised safety analysis set 
and for the patients in the set with the baseline hemoglobin level ≤110 g/L. Summary of 
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maximum increase per patient will be also provided using descriptive statistics and using a 
waterfall plot.  
6.4.3.7
Other exploratory endpoints
Rate of VGPR or CR per overall combined assessment by investigator as mentioned in Section 4.3
will be analyzed using same method in Section 6.4.2.1.
Duration of overall response and duration of VGPR or CR as mentioned in Section 4.3 will be 
analyzed using same method in Section 6.4.2.3.
Time to overall response and time to VGPR or CR as mentioned in Section 4.3 will be analyzed 
using same method in Section 6.4.2.4.
6.4.4
Sensitivity Analyses
Sensitivity analyses may be performed by repeating analysis of selected efficacy endpoints in the 
PP analysis set as necessary.
6.4.5
Subgroup Analyses
Primary and selected secondary efficacy endpoints will be summarized in the subgroups, including 
below, as appropriate (ie. when there is sufficient number of patients in the subgroup, otherwise 
relevant subgroups may be combined): gender, age group (< 65 years vs. ≥ 65 years), ECOG-
performance status (0 vs. ≥ 1), MYD88/CXCR4 mutation status (MYD88 L265P mutation,
MYD88 L265P mutation/CXCR4 WHIM, MYD88 L265P mutation/CXCR4 wild-type, MYD88
wild-type/CXCR4 wild-type, MYD88 wild-type), baseline bone marrow involvement (lower limit
≥50% vs. higher limit < 50% vs. other), WM IPSS score (low, intermediate, high), baseline serum 
β2 microglobulin level (≤3 mg/L vs. > 3 mg/L), number of prior systemic regimens (1-2 vs >=2),
baseline IgM level (<40 g/L vs >=40 g/L), baseline platelet count (≤ 100 x 109/L vs > 100 x 109/L), 
baseline hemoglobin ( ≤ 110 g/L vs >110 g/L), and baseline extramedullary disease (yes vs no)
identified by either CT scan or physical exam per investigator. Subgroup results will be presented 
in forest plots also. The subgroup variables and their respective categories are subject to change if 
warranted to better represent the data.  
6.4.6
Biomarker/Pharmacodynamic Endpoints
Numbers (%) of patients with MYD88 and/or CXCR4 mutation will be presented.
Correlation analysis between the mutation status and response status might be performed. An
independent biomarker SAP will be generated to describe the detailed analyses for these 
endpoints. 
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6.5
SAFETY ANALYSES
All safety analyses will be based on the safety analysis set. The study will set up a Safety 
Monitoring Committee (SMC). The SMC will monitor safety data according to the SMC charter 
(Appendix C) throughout the study.
6.5.1
Extent of Exposure
Extent of exposure to the study drug will be summarized descriptively with respect to the 
following:
x
Number of treatment cycles received: defined as duration of exposure (days)/28.
x
Duration of exposure (days): defined as the duration (in days) from the date of the first 
dose to the last dose of the study drug for patients who discontinued treatment, or the 
database cutoff date for ongoing patients.
Categorical distribution of duration of exposure will also be provided.
x
Total dose received (g): defined as the cumulative dose of the study drug during the 
treatment period of the study.
Note: If the actual dose received during a period is unknown (e.g. diary not returned, and 
no other information can be used), it will be considered as the study drug was administrated 
as prescribed conservatively.
x
Actual dose intensity (mg/day): defined as the total dose (in mg) received by a patient
divided by the duration of treatment (in day).
Note: For patients who are ongoing at the data cutoff, the actual dose intensity is calculated 
based on study drug administration data prior to data cutoff as the total dose (in mg) 
received by a patient prior to the cutoff divided by the duration from first dose date to the 
end date of the last study drug administration record.
x
Relative dose intensity: defined as the ratio of the actual dose intensity (mg/day) and the
planned dose intensity in percentage. Planned dose intensity is 320 mg/day.
The number (%) of patients requiring dose reductions, dose interruption, dose missed, and drug 
discontinuation due to AEs will be summarized. The cycle in which the first dose 
reduction/interruption occurred will be summarized using descriptive statistics. Frequency of dose 
reductions and interruptions as well as reason for dose reductions and interruptions will be 
summarized descriptively.
The cycles used in the dose exposure analysis will be derived from the date of visit (DOV) if the 
cycle information is not available. The start date of each cycle will be set as the DOV for that 
cycle, and the end date will be one day before the DOV for next cycle. When DOV for certain 
cycle is not available (patient missed certain cycle visit), cycle duration before and after the 
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missing visit will be assigned evenly. For example, if for one patient, cycle 2 visit is missing, and 
the duration between cycle 1 and cycle 3 (C3D1-C1D1+1) is 58 days, the duration for cycle 1 and 
cycle 2 will be assigned both as 29 days, with imputed cycle 2 DOV as C1D1+29-1.
Dose reduction is defined as any planned dose reduced from the original planned dose (160mg 
BID), regardless of reasons. Dose interruption is defined as any dose temporary discontinuation 
due to AE or held for procedure. Dose missing is defined as any dose temporary discontinuation 
due to reasons other than AE or held for procedure. Since dose interruption also need to be 
analyzed by cycle, for patients with dose interruption but with missing start/stop date, the end date 
will be imputed with the corresponding AE stop date, the dose interruption start date will be back 
calculated based on the dosage missing reported. If the dosage is also missing, the start and stop 
date of the dose interruption will be imputed with the AE start/stop date.
6.5.2
Adverse Events
AEs will be graded by the investigators using CTCAE v4.03. The AE verbatim descriptions 
(investigator terms from the CRF) will be classified into standardized medical terminology using 
the Medical Dictionary for Regulatory Activities (MedDRA). Adverse events will be coded to the 
MedDRA (Version 20.0 or higher) lower level term closest to the verbatim term. The linked 
MedDRA preferred term (PT) and primary system organ class (SOC) are also captured in the 
database.
A treatment-emergent adverse event (TEAE) is an AE with an onset time or increase in severity 
level on or after the first dose of study drug and within 30 days after the last dose of study drug 
or prior to the initiation of new anti-cancer therapy, whichever is sooner. Only those AEs that 
were treatment emergent will be included in summary tables.  All AEs, treatment emergent or 
otherwise, will be presented in patient data listings.
Treatment-related AEs include those events assessed by the investigator to be related, possibly
related, probably related to study drug, unlikely related or with missing assessment of the causal 
relationship. 
The incidence of TEAEs will be summarized based the number (%) of patients with TEAEs by 
SOC, PT and grade.  A patient will be counted only once by the highest severity grade according 
to CTCAE v.4.03 and strongest causal relationship to zanubrutinib 1) within a given SOC and 2)
within a given SOC and PT, even if the patient experienced more than one TEAE within a specific 
SOC and PT. 
An overall summary of TEAEs will include the number (%) of patients:
x
With at least one TEAE
x
With at least one treatment-related TEAE
x
With at least one grade 3 or higher TEAE
x
With at least one treatment-related grade 3 or higher TEAE
x
With at least one TEAEs that led to death
x
With at least one treatment-related TEAE that led to death
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x
With at least one serious TEAE
x
With at least one treatment-related serious TEAE
x
With at least one TEAE that led to treatment discontinuation
x
With at least one treatment-related TEAE that led to treatment discontinuation
x
With at least one TEAE that led to dose modification
x
With at least one treatment-related TEAE that led to dose modification
x
With at least one TEAE that led to dose reduction
x
With at least one treatment-related TEAE that led to dose reduction
x
With at least one TEAE that led to treatment interruption
x
With at least one treatment-related TEAE that led to treatment interruption
x
With at least one TEAE of special interest
x
With at least one treatment-related TEAE of special interest
The number (%) of patients with TEAE, serious TEAE, TEAEs with grade 3 or above, TEAEs 
that led to death, and TEAEs that led to treatment discontinuation, dose modification (reduction or 
interruption), treatment-related TEAEs, treatment-related TEAE with grade 3 or above and
treatment-related serious TEAE, treatment-related TEAEs that led to treatment discontinuation,
dose modification (reduction or interruption) and death will be summarized by SOC, PT and grade.
Summaries of all TEAEs, SAE, grade 3 or higher TEAEs will also be summarized by PT in 
descending order. 
AE of special interest (AESI) will be defined and summarized by AESI category name and PT for 
all AESI, treatment related AESI, AESI of grade 3 or higher, serious AESI, AESI leading to 
treatment discontinuation, dose reduction/treatment interruption, and death. Besides, AESI will 
be summarized by category name, PT and grade. The AESI categories and detailed search criteria 
will be provided separately.
Same summaries will be provided for other adverse events by organ system or syndrome if 
necessary.
Exposure-Adjusted Incidence Rates (EAIR)
Exposure-adjusted incidence rate (EAIR) by category will also be calculated for AESIs. In 
calculating EAIR, the analysis restricts on the occurrence of the first event per patient and ignores 
the existence of later (multiple) events as these cannot be assumed to occur independent of 
previous events. The incidence rate for a patient is derived from the duration of treatment exposure 
of that patient. A patient’s duration of exposure is given either 1) by the time when the first event 
has occurred, or the treatment has ended, whichever is earlier (non-censored data), or 2) by the 
total duration of exposure from first dose date to last dose date or the data cutoff date (whichever 
is earlier) in case the patient does not experience the event (censored data). Depending on whether 
a patient has an event or not, the duration of exposure enters the denominator in its non-censored 
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or censored form, respectively. The EAIR per event considers the first event per patient only, and 
the corresponding exposure time in the denominator:
ܧܣܫܴ௘௩௘௡௧= ∑
ܣܧܵܫ௘௩௘௡௧,௜
௡
௜ୀଵ
∑
ݐ௘௩௘௡௧,௜
௡
௜ୀଵ
Whereby AESIevent,i represents if patient i experienced the event (1) or not (0), and tevent,i as time 
when the first AESI occurs or the treatment ends, whichever is earlier (non-censored data) or total 
duration of treatment if no event occurs (censored data).
An exploratory analysis of the correlation between the incidence of an AE of hemorrhage and the 
prior use of anti-platelet and anti-coagulant medications will be performed. Other exploratory 
analysis will be performed if needed.
A summary of the number of deaths and the cause of death, classified by deaths within 30 days of 
last dose of study drug and deaths more than 30 days after the last dose, will be provided.
Patient data listings of deaths, all AEs, SAEs, treatment-related AEs, grade 3 or above AEs, AEs 
that led to death, AEs that led to dose modification (reduction/interruption) and AEs that led to 
treatment discontinuation will be provided.
6.5.3
Laboratory Values
Descriptive summary statistics (eg, n, mean, standard deviation, median, minimum, maximum 
for continuous variables; n [%] for categorical variables) for selected laboratory parameters and 
their changes from baseline will be summarized by visit.
Laboratory parameters that are graded in CTCAE (v.4.03) will be summarized by shifts table 
assessing the CTCAE toxicity grades at baseline versus worst toxicity recorded post-baseline.  In 
the summary of laboratory parameters by CTCAE grade, parameters with CTCAE grading in
both high and low directions (eg, calcium, glucose, magnesium, potassium, sodium) will be 
summarized separately.
Patient data listings of following selected (not limited to) laboratory parameters will be provided.
Similar listing with only grade 3 and 4 lab assessments will also be provided.
•
Hematology laboratory assessments: Hemoglobin, Platelets, Leukocytes, Neutrophils, 
Lymphocytes.
•
Coagulation profile: Activated Partial Thromboplastin Time (aPTT), Intl. Normalized Ratio 
(INR).
•
Chemistry laboratory assessments: Alkaline Phosphatase (ALP), Alanine Aminotransferase
(ALT), Aspartate Aminotransferase (AST), Albumin, Total Bilirubin (TBL), Calcium, 
Creatinine, Glucose, Potassium, Sodium, Magnesium, Phosphate, Urate.
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•
Urine laboratory assessments: Urine pH, Urine Glucose, Urine Protein, Urine Ketones, 
Urine Occult Blood, Urine Specific Gravity.
IgA, IgG and their changes from baseline will be summarized by visit.
For hypocalcemia and hypercalcemia, serum calcium will be corrected using the following 
formula:
Corrected calcium = Serum calcium + 0.8 * (4 – serum albumin) where serum calcium is 
recorded in mg/dL and serum albumin is recorded in g/dL.
A summary of the number (%) of patients with grade 3 or higher toxicity will be provided for 
selected laboratory parameter of interest. Box and whiskers plots will be generated for 
parameters of interest.
Hy’s Law criteria is defined with ALT or AST > 3xULN and TBL > 2xULN and ALP < 2xULN; 
TBL and ALP were both within 28 days after ALT or AST elevation. Incidence of patients who 
met one or more of the Hy’s law criteria will be summarized. A listing of patients that met one or 
more of the Hy’s law criteria will be generated.
6.5.4
Vital Signs
Descriptive statistics for vital sign parameters (systolic and diastolic blood pressure, heart rate, 
respiratory rate, temperature, weight) and changes from baseline will be presented at each
scheduled visit. Vital signs will be listed by patients and visits. A shift table assessing the 
toxicity grade at baseline versus worst toxicity recorded post-baseline will also be presented for 
systolic and diastolic blood pressure. Box and whiskers plots will be generated for actual value 
and change from baseline for systolic and diastolic blood pressure.
6.5.5
Electrocardiograms (ECG)
ECG assessments will be performed at Screening and end of treatment (EOT) visit. Patient listing 
for ECG data will be provided.
6.5.6
ECOG
A shift table assessing the Eastern Cooperative Oncology Group (ECOG) performance status at 
baseline versus worst performance status post-baseline will be presented. ECOG performance 
status will be summarized and listed by visit.
6.6
OTHER ANALYSES
Additional exploratory analyses may be conducted as appropriate. Any exploratory analyses that 
are performed will be appropriately titled/labeled as exploratory and will be clearly distinguished 
from planned analyses when results are reported in the Clinical Study Report.
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7
INTERIM ANALYSIS
There will be one interim safety analysis based on an earlier data cutoff at 02-DEC-2018, which 
is about 7 months after last patient first dosed, for the purpose of regulatory filing. The trial will 
be continued regardless of the interim analysis result and therefore no multiplicity adjustment will 
be needed. 
8
CHANGES IN THE PLANNED ANALYSIS
The following changes to the planned analysis were made:
x
The revised safety analysis set (ie, the analysis set used for efficacy) is updated to exclude 
the patients with baseline IgM (or M-protein) <5 g/L.
x
The per-protocol analysis set is updated to include patients in the revised safety analysis 
set without important protocol deviations.
x
For anti-lymphoma effect, “hepato-” is removed from “hepatosplenomegaly” as the 
adaptation of the response criteria per the Sixth IWWM consensus guideline (Owen et al 
2013) does not include evaluation for hepatomegaly. 
x
Some efficacy endpoints which were not defined in the protocol are added to the SAP.
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9
REFERENCES
1. Brookmeyer, R. and Crowley, J. (1982), A confidence interval for the median survival 
time, Biometrics, 38: 29-41.
2. Common Toxicity Criteria Version 4.03. (2010), Cancer Therapy Evaluation Program. 
14 June 2010.
3. Dimopoulos MA, Kastritis E, Owen RG, et al. (2014), Treatment recommendations for 
patients with Waldenstrom macroglobulinemia (WM) and related disorders: IWWM-7
consensus, Blood, 124:1404-11.
4. Food and Drug Administration Center for Drug Evaluation Research CDER and Center 
for Biologics Evaluation and Research (2007), FDA Guidance for Industry Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics.
5. Greenwood, M. (1926) The natural duration of cancer. Public health and medical 
patients, 33: 126.
6. Kalbfleisch, J. D. and Prentice, R. L. (1980), The Statistical Analysis of Failure Time 
Data, New York: John Wiley & Sons. 
7. Klein, J. P. and Moeschberger, M. L. (1997), Survival Analysis: Techniques for Censored 
and Truncated Data, New York: Springer-Verlag.
8. Schemper, M. and Smith T.L., (1996), A note on quantifying follow-up in studies of 
failure time, Controlled Clinical Trials, 17: 343-346.
9. Owen RG, Pratt G, Auer RL, et al. Response assessment in Waldenstrom 
macroglobulinaemia: update from the VIth International Workshop. Br J of Haematol,
2013;160:171-6.
10. NCCN Guidance Insights, JNCCN 2012;10:1211-1218
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10 APPENDIX
Appendix A: Missing Data Imputation Rule 
In general, missing or partial dates will not be imputed at data level. The following rules will apply 
for the specific analysis and summary purposes mentioned below only.  
A.1 Prior/Concomitant Medications/Procedures
When the start date or end date of a medication is partially missing, the date will be imputed to 
determine whether the medication is prior or concomitant. The following rules will be applied to 
impute partial dates for medications:
If start date of a medication is partially missing, impute as follows:
x
If both month and day are missing, then set to January 01
x
If only day is missing, then set to the first of the month
If end date of a medication is partially missing, impute as follows:
x
If both month and day are missing, then set to December 31
x
If only day is missing, then set to last day of the month
If start date or end date of a medication is completely missing, do not impute.
If the imputed end date > death date or end of study date, then set to the death date or end of study 
date, whichever occurs first.
A.2 Adverse Events
The imputation rule for the safety analyses will be used to address the issues with partial dates. 
When the start date or end date of an adverse event is partially missing, the date will be imputed 
to determine whether the adverse event is treatment-emergent. When in doubt, the adverse event 
will be considered treatment emergent by default. The following rules will be applied to impute 
partial dates for adverse events:
If start date of an adverse event is partially missing, impute as follows:
x
If both month and day are missing, then the imputed day and month will be January 01 or 
the first dosing date if they have the same year, whichever is later.
x
If only day is missing, then the imputed day will be the first day of the month or the first 
dosing date if they have the same month and year, whichever is later 
x
If start date is completely missing, the imputed day will be the first dosing date as long as 
AE end date is not before the first dosing date. 
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If end date of an AE is partially missing, impute as follows:
x
If both month and day are missing, then set to December 31
x
If only day is missing, then set to last day of the month
x
If end date is completely missing, do not impute.
If the imputed AE end date > death date or end of study date, then set to the death date or end of 
study date, whichever occurs first.
A.3 Deaths
In case complete death dates are not recorded, impute as follows:
x
If both month and day are missing, then the imputed month and day will be 01Jan or the 
last date of patient known to be alive + 1, whichever is later.
x
If only day is missing, the death will be assumed to be on the first day of the month or the 
last date of patient known to be alive +1, whichever is later. 
A.4 Subsequent Anti-cancer Therapies
If the start date of a subsequent anti-cancer therapy is incomplete or missing, impute as follows:
x
If both month and day are missing, then the imputed month and day will be 01Jan or the 
last day of the month for the last adequate disease assessment if they have the same year.
x
If only day is missing, then the imputed day will be the first day of the month.
A.5 Diagnosis
If a diagnosis date is partially missing, impute as follows:
x
If both month and day are missing, then set to January 01
x
If only day is missing, then set to the first of the month
If a diagnosis date is completely missing, do not impute.
A.6 Prior Therapy/Response to Prior Therapy
If a prior therapy or response to prior therapy date is partially missing, impute as follows:
x
If only day is missing, then set to the 15th of the month
No imputation will be performed for all other types of missing dates.
A.7 Bone Marrow Involvement
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Bone marrow will be assessed by biopsy at screening, every 24 weeks, at time of CR and clinical 
indicated. Values for neoplastic B-lymphocytes and plasma cells from biopsy will be added to 
determine the baseline bone marrow involvement for subgroup analysis. Given that the test values
in the original reports are shown in various formats, following rules will be applied to better 
capture the magnitude of the bone marrow involvement at baseline. If any of the values are not 
captured in following cases, appropriate rules will be applied and stated in the study report. 
1) If the value is shown as one single numeric value, i.e. X, assign lower limit and upper limit of
bone marrow involvement for the patient both as X.
2) If the value is shown as a range, i.e. X-Y, assign lower limit as X and upper limit as Y for the 
patient.
3) If the value is shown with an upper limit only, i.e. <X or <=X, assign lower limit as 0 and 
upper limit as X for the patient.
4) If the value is shown as “easy to see”, assign lower limit as 0 and upper limit as 20 for the 
patient.
5) If the value is shown with “ND”, assign both lower limit and upper limit as 0 for the patient.
Total bone marrow involvement will be obtained by adding the lower and upper limit values of
neoplastic B-lymphocytes and plasma cells together, respectively. For each patient, if lower limit
of the combined value is ≥50%, then he/she will be categorized to the subgroup of baseline bone 
marrow involvement lower limit ≥50%; If upper limit of the combined value is < 50%, then 
he/she will be categorized to the subgroup of baseline bone marrow involvement higher limit <
50%. 
To determine the anti-lymphoma effect, it’s required to check if there is any reduction in bone 
marrow involvement at any post-baseline visits onwards. If the post-baseline bone marrow 
involvement and baseline bone marrow involvement are both reported as a range (eg. baseline 
reported with lower limit a and upper limit b, postbaseline reported with a lower limit c and upper 
limit d), the following rules will be used to determine if there is reduction:
x
If a<b<c<d, then no reduction
x
If a<c<b<d, then no reduction
x
If a<c<d<b, indeterminate
x
If c<a<b<d. indeterminate
x
If c<a<d<b, slight reduction
x
If c<d<a<b, then reduction
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A.8 WM International Prognostic Scoring System (IPSS)
Score:
x
Age > 65 year
x
Hemoglobin ≤ 11.5 g/dL 
x
Platelet count ≤ 100 x 109/L 
x
β2-microglobulin > 3 mg/L 
x
Monoclonal IgM concentration > 7.0 g/dL
IPSS:
x
Low: 0 or 1 (except age) score 
x
Intermediate: age or 2 scores 
x
High: ≥ 3 scores
Source: International prognostic scoring system for Waldenstrom macroglobulinemia, Blood. 
2009;113:4163-4170
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Appendix B: Response Assessment
B1. WM Response Assessment Methods
Owens (IWWM 6th) Criteria
Overall Combined Assessment
Overall IgM Assessment
Monoclonal IgM by 
immunofixation
X
X
IgM level (Include M-protein)*
X
X
Bone marrow
X
Extramodular disease per CT or PE
X
New Signs and symptoms of active 
disease, clinical features of PD
X
Drug holds
X
X
* Patients may undergo plasmapheresis, when clinically indicated, during the first two cycles of study 
treatment. A pre-plasmapheresis serum total IgM and M-protein must be obtained during the screening 
period, and will serve as the baseline value for response assessment throughout the study. Response 
determination will commence 4 weeks following the last plasmapheresis procedure and will be based upon 
the baseline pre-plasmapheresis serum total IgM or M-protein value (according to the guidelines above). 
Patients requiring plasmapheresis after cycle 2 will be adjudged to have progressive disease.
B2. Categorical Response Definitions (modified Owen 2013)
Response category
Definition
Complete response (CR)
Absence of serum monoclonal IgM protein by immunofixation
Normal serum IgM level
Complete resolution of extramedullary disease, 
ie, lymphadenopathy and splenomegaly if present at baselines
No histological evidence of bone marrow involvement
Very good partial response (VGPR)
Monoclonal IgM protein is detectable
≥ 90% reduction in serum IgM level from baseline a
Improvement in extramedullary disease, 
ie, lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Partial response (PR)
Monoclonal IgM protein is detectable
≥ 50% but < 90% reduction in serum IgM level from baseline a
Improvement in extramedullary disease, 
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ie, lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Minor response (MR)
Monoclonal IgM protein is detectable
≥ 25% but< 50% reduction in serum IgM level from baseline a
No new signs or symptoms of active disease
Stable disease (SD)
Not meeting criteria for CR, VGPR, PR, MR, or progressive disease
Progressive disease (PD)
At least one of the following: 
• Confirmed ≥ 25% increase in serum IgM and total increase of ≥ 
500 mg/dL from nadir (on treatment) a,b
• New lymph nodes >1.5 cm, or ≥ 50% increase from nadir in SPD of 
>1 node, or ≥ 50% increase in longest diameter of a previously 
identified node >1 cm in short axis 
• New splenomegaly or ≥50% increase from nadir in enlargement 
• New extranodal disease
• New or recurrent involvement in bone marrow
• New symptomatic disease
a Sequential changes (separated by at least 4 weeks) in IgM levels should be determined by the IgM value from the 
quantitative serum immunoglobulin assay, unless for assay limitations this is not possible, in which case the M 
protein level by densitometry (SPEP) will be used
b Isolated increase in serum IgM levels during periods of study drug withholding will not be considered as 
progressive disease unless confirmed by a repeat serum IgM level at least 10 weeks after restarting study drug 
administration and accompanied by a total increase of at least 500mg/Dl from lowest nadir. Please see guidelines for 
specific clinical or laboratory circumstances below.
c For response assessments that occur during cycles where a CT scan is not required then results from prior scans 
(up to 12 weeks during the first 48 weeks and up to 24 weeks thereafter) can be carried forward in those patients
with extramedullary disease at baseline.
Refer to the IRC charter (appendix E) for detailed instructions.
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Appendix C: Safety Monitoring Committee Charter
The safety monitoring committee charter is provided in a separate document.
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Appendix E: Independent Review Charter
The independent review charter is provided in a separate document.
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