Conditions: Marginal Zone Lymphoma MZL
Keywords: BGB-3111 Zanubrutinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 68
Healthy volunteers: no

Brief summary:
This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).

Detailed description:

Arms:
arm 1: Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

Interventions: intervention 1: Zanubrutinib
Intervention descriptions: intervention 1: Zanubrutinib at a dose of 160 mg orally twice a day (BID)

Protocol document:
Prot_000.pdf: 
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SAP_001.pdf: 
BeiGene USA, Inc
BGB--214 
  (Statistical Analysis Plan) 
Version Final:  10-Jun-2020 
Page 1 of 27
CONFIDENTIAL
STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-3111-214 
Study Protocol 
Title: 
A Phase 2, Open-Label Study of Zanubrutinib (BGB-3111) in Patients 
with Relapsed or Refractory Marginal Zone Lymphoma 
Date: 
10-June-2020 
Version: 
Final 
1&7


BeiGene USA, Inc
                  BGB--214
              (Statistical Analysis Plan)
Version Final:  10-Jun-2020
Page 2 of 27
CONFIDENTIAL
SIGNATURE PAGE
Author: 
 
  
BeiGene Co., Ltd.
              
Approval
BeiGene Co., Ltd.
BeiGene Co., Ltd.


 
BeiGene USA, Inc
                  BGB--214 
              (Statistical Analysis Plan) 
 
 
 
Version Final:  10-Jun-2020 
Page 3 of 27
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 
9 
4 
STUDY ENDPOINTS 
10 
4.1 
Primary Endpoints 
10 
4.2 
Secondary Endpoints 
10 
4.3 
Exploratory Endpoints 
10 
5 
SAMPLE SIZE CONSIDERATIONS 
10 
6 
STATISTICAL METHODS 
11 
6.1 
Analysis Sets 
11 
6.2 
Data Analysis General Considerations 
11 
6.2.1 
Definitions and Computations 
11 
6.2.2 
Conventions 
11 
6.2.3 
Handling of Missing Data 
12 
6.2.4 
Adjustment for Covariates 
12 
6.2.5 
Multiplicity Adjustment 
12 
6.2.6 
Data Integrity 
12 
6.3 
Patient Characteristics 
12 
6.3.1 
Patient Disposition 
12 
6.3.2 
Protocol Deviations 
13 
6.3.3 
Demographic and Other Baseline Characteristics 
13 
6.3.4 
Disease History and Characteristics 
13 
6.3.5 
Prior Anti-Cancer Drug Therapies 
14 
6.3.6 
Prior and Concomitant Medications 
14 
6.3.7 
Medical History 
15 
6.4 
Efficacy Analysis 
15 
6.4.1 
Primary Efficacy Endpoint 
15 
6.4.2 
Secondary Efficacy Endpoints 
15 
6.4.3 
Subgroup Analyses 
19 
6.4.4 
Exploratory Efficacy Endpoints 
19 
6.5 
Pharmacokinetic Analyses 
19 
6.6 
Safety Analyses 
20 
6.6.1 
Extent of Exposure 
20 
6.6.2 
Adverse Events 
20 
6.6.3 
Laboratory Values 
22 
6.6.4 
Vital Signs 
22 
6.6.5 
Electrocardiogram (ECG) 
23 


 
BeiGene USA, Inc
                  BGB--214 
              (Statistical Analysis Plan) 
 
 
 
Version Final:  10-Jun-2020 
Page 4 of 27
CONFIDENTIAL
 
6.6.6 
Eastern Cooperative Oncology Group Performance Status 
(ECOG) 
23 
6.7 
Other Analyses 
23 
7 
INTERIM ANALYSIS 
23 
8 
CHANGES IN THE PLANNED ANALYSIS 
23 
9 
REFERENCES 
24 
10 
APPENDIX 
25 
Appendix A: 
Missing Data Imputation Rule 
25 
Appendix B: Specification on the Use of Lab Data 
27 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 


 
BeiGene USA, Inc
                  BGB--214 
              (Statistical Analysis Plan) 
 
 
 
Version Final:  10-Jun-2020 
Page 5 of 27
CONFIDENTIAL
 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
AE  
adverse event  
ATC 
Anatomical Therapeutic Chemical 
AUC  
area under the curve  
BTK  
Bruton tyrosine kinase  
CI  
confidence interval  
Cmax  
maximum plasma concentration  
CR  
complete response  
CRu  
complete remission unconfirmed  
CT  
computed tomography  
CRF 
case report form 
CV 
coefficient of variation 
DOR  
duration of response  
ECG  
electrocardiogram  
ECOG  
Eastern Cooperative Oncology Group  
eCRF  
electronic case report form  
EORTC QLC-C30  
European Organisation for Research and Treatment of Cancer Quality 
of Life Questionnaire-C30  
EQ 5D-5L  
5-level EQ-5D version  
FDA  
Food and Drug Administration  
GeoMean 
geometric mean 
GeoCV 
geometric coefficient of variation 
IC50  
50% maximum inhibitory concentration  
IRC 
independent review committee 
MedDRA 
Medical Dictionary for Regulatory Activities  
MZL  
marginal zone lymphoma  
MALT 
mucosa-associated lymphoid tissue 
NCI-CTCAE  
National Cancer Institute Common Terminology Criteria for Adverse 
Events  


 
BeiGene USA, Inc
                  BGB--214 
              (Statistical Analysis Plan) 
 
 
 
Version Final:  10-Jun-2020 
Page 6 of 27
CONFIDENTIAL
 
NHL  
non-Hodgkin lymphoma  
ORR  
overall response rate  
OS  
overall survival  
PD  
progressive disease  
PET  
positron emission tomography  
PFS  
progression-free survival  
PK  
pharmacokinetic  
PP 
per-protocol 
PR  
partial response  
PRO  
patient-reported outcome  
PT  
preferred term  
Q1 
quartile 1 
Q3 
quartile 3 
R/R MZL  
relapsed or refractory marginal zone lymphoma  
SAP 
statistical analysis plan 
SD  
stable disease  
SOC  
system organ class  
TEAE  
treatment-emergent adverse event  
TTF 
time to failure 
TTR  
time to response  
WHO-DD 
World Health Organization Drug Dictionary 
 


 
BeiGene USA, Inc
                  BGB--214 
              (Statistical Analysis Plan) 
 
 
 
Version Final:  10-Jun-2020 
Page 7 of 27
CONFIDENTIAL
 
1 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to describe the procedures and statistical 
methods that will be used to analyze and report results for the protocol BGB-3111-214 
amendment 3.0 dated 03-Jun-2020 titled: A Phase 2, Open-label Study of Zanubrutinib (BGB-
3111) in Patients with Relapsed or Refractory Marginal Zone Lymphoma. The focus of this SAP 
is for the planned primary and final analyses specified in the study protocol.  
2 
STUDY OVERVIEW 
This is a multi-center, single-arm, open-label, phase 2 clinical study to evaluate the safety and 
efficacy of zanubrutinib in patients with relapsed or refractory marginal zone lymphoma (R/R 
MZL).  The study is composed of an initial screening phase (up to 35 days), a single-arm 
treatment phase, and a follow-up phase with a safety follow-up and a long-term follow-up. 
Approximately 65 patients will be enrolled. The primary efficacy analysis will be conducted 
when mature response rate data have been observed, estimated as no later than 6 months after the 
last patient receives the first dose of study drug; and the final analysis will be conducted when 
mature data of secondary endpoints are available. For the primary efficacy analysis, response 
will be evaluated by an Independent Review Committee (IRC) using the 2014 Lugano 
Classification for Non-Hodgki
s Lymphoma (NHL) criteria (Cheson et al 2014).  
Computed tomography (CT) with contrast will be performed at screening, at 12, 24, 36, and 48 
weeks, followed by every 24 weeks thereafter (72 weeks, 96 weeks, etc.) until disease 
progression, withdrawal of consent, death, lost to follow-up, or end of study, whichever occurs 
first. Magnetic resonance imaging (MRI) may be used in patients who have severe allergy to CT 
contrast, but if used, should be used consistently throughout the study. Positron emission 
tomography (PET) scan will be performed at screening, and repeated for those with PET-avid 
disease at 12, 24, 36, 48, and 72 weeks. For patients with PET-avid disease, an assessment of 
complete response (CR) or progressive disease (PD) must be confirmed by PET scan. Patients 
should remain on study treatment until disease progression is confirmed by investigator 
assessment using available radiographic and clinical findings based on the Lugano criteria 
(Cheson et al 2014). Bone marrow biopsy and aspirate will be repeated at time of suspected CR 
for those patients who had bone marrow involvement by MZL at screening. For patients with 
gastrointestinal involvement who had an endoscopy performed during the screening period, a 
follow up endoscopy is required to confirm CR. 
After informed consent has been signed but prior to the administration of the study drug, only 
serious adverse events (AEs) should be reported. Thereafter, all AEs and serious AEs, regardless 
of relationship to study drug, will be reported until 30 days after the last dose of study drug. 
After this period, the investigator should report any serious AEs that are believed to be related to 
prior study drug treatment.  
 
Screening Phase: All screening procedures must be performed within 35 days prior to the first 
dose of zanubrutinib, unless noted otherwise; assessments not completed within this interval 
must be repeated. Patients will sign the informed consent form prior to any screening 
evaluations.  
Treatment Phase: Patients will receive the first dose of zanubrutinib at Cycle 1 Day 1. All 


 
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patients will be treated with zanubrutinib at 160 mg orally twice daily (two 80-mg capsules 
orally twice daily) to be continued until disease progression, unacceptable toxicity, treatment 
consent withdrawal, or study termination. Each cycle consists of 28 days.  
Safety Follow-up: All patients who permanently discontinue study drug will have a Safety 
Follow-up visit approximately 30 days after the last dose of study drug to collect AEs, including 
AEs that may have occurred or been ongoing after the patient discontinued study treatment. The 
investigator or his/her designee will also continue to collect information on new anti-cancer 
therapy given after the last dose of study drug. A laboratory assessment is only required if the 
patient had an ongoing laboratory abnormality at the previous visit that the investigator 
considered to be related to study drug.  
Long-term Follow-up: Long-term Follow-up visits will be conducted every 24 weeks after the 
last dose of study drug until withdrawal of consent, lost to follow-up, death, or study termination. 
It includes monitoring survival status and subsequent therapies for MZL and may also include 
imaging and tumor response assessments for patients who have not yet had confirmed 
radiographic progression. For patients who permanently discontinue study drug treatment before 
radiographic progression is documented, tumor assessments (including radiographic imaging) 
will continue until radiographic progression is identified and confirmed by the investigator. 
Imaging assessments should occur every 12 weeks until what would have been Week 48 and 
then approximately every 24 weeks thereafter.  
 
Figure 1 
Schema for Study BGB-3111-214 
 
 
 


 
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3 
STUDY OBJECTIVES 
3.1 
PRIMARY OBJECTIVES 
To evaluate the efficacy of zanubrutinib in R/R MZL as measured by overall response rate (ORR) 
in accordance with the Lugano Classification (Cheson et al 2014) determined by IRC 
3.2 
SECONDARY OBJECTIVES  
 To evaluate the efficacy of zanubrutinib in R/R MZL in accordance with the Lugano 
Classification (Cheson et al 2014) as measured by the following: 
o ORR determined by investigator  
o Progression-free survival (PFS) determined by IRC and by investigator 
o Overall survival (OS) 
o Duration of response (DOR) determined by IRC and by investigator 
o Time to response (TTR) determined by IRC and by investigator 
o Time to treatment failure (TTF) 
o Time to next line of therapy for MZL 
 To evaluate patient-reported outcomes (PROs) 
 To determine the safety of zanubrutinib 
 To determine pharmacokinetics (PK) parameters of zanubrutinib 
3.3 
EXPLORATORY OBJECTIVES 
 To evaluate ORR in accordance with Cheson 1999 as determined by IRC 
 
 
 
 


 
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4 
STUDY ENDPOINTS 
4.1 
PRIMARY ENDPOINTS 
The primary endpoint of the study is ORR, defined as the proportion of patients achieving a best 
overall response of either partial response (PR) or complete response (CR) as determined by IRC 
according to the 2014 Lugano Classification for Non-
 criteria 
(Cheson et al 2014) at any time on study drug. 
4.2 
SECONDARY ENDPOINTS 
The secondary endpoints are: 
 ORR (CR + PR) in accordance with the Lugano Classification (Cheson et al 2014) 
determined by investigator assessment 
 ORR (CR + PR) in accordance with the Lugano Classification (Cheson et al 2014) using PET 
assessment data for patients with FDG avid disease determined by IRC 
 PFS in accordance with the Lugano Classification (Cheson et al 2014) determined by IRC 
and by investigator assessment 
 OS 
 DOR in accordance with the Lugano Classification (Cheson et al 2014) determined by IRC 
and by investigator assessment 
 TTR in accordance with the Lugano Classification (Cheson et al 2014) determined by IRC 
and by investigator assessment 
 TTF 
 Time to next line of therapy for MZL 
 PROs measured by the EQ-5D-5L and EORTC QLQ-C30 questionnaire 
 Safety parameters including AEs, Serious AEs, laboratory tests, physical exams, and vital 
signs 
 PK parameters such as apparent clearance of the drug from plasma (CL/F) and AUC0-12 
4.3 
EXPLORATORY ENDPOINTS 
 ORR (CR + unconfirmed CR [CRu] +PR) in accordance with Cheson 1999 as determined by 
IRC 
5 
SAMPLE SIZE CONSIDERATIONS 
Assuming a null hypothesized ORR of 30%, a sample size of 65 patients will provide 82% 
power for the alternative hypothesized ORR of 48%, at a 1-sided alpha level of 0.025 and using 
the exact binomial test. The alternative ORR is based on the observed IRC-assessed ORR for the 
ibrutinib study in R/R MZL (Noy et al 2017).  For an observed ORR of 48% (31/65), the 95% 
exact binomial confidence interval is (35%, 60%). 


 
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6 
STATISTICAL METHODS 
6.1 
ANALYSIS SETS 
The Safety Analysis set includes all patients who are enrolled and receive any dose of 
zanubrutinib. This will be the population of primary interest for safety analyses.  
The Efficacy Analysis set consists of all patients in the Safety Analysis set with confirmed 
diagnosis of MZL. This set will be the primary analysis set for efficacy analyses.  
The PK Analysis set includes all patients who have at least one PK sample collected (have at 
least one post-dose PK concentration) according to the protocol and laboratory manual. 
6.2 
DATA ANALYSIS GENERAL CONSIDERATIONS 
6.2.1 
Definitions and Computations 
Study drug: the study drug in 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.  
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 on/before the first dose date of study drug. 
Retests and Unscheduled Visits: Unscheduled measurements will not be included in by-visit 
table summaries and graphs, but will contribute to best/worst case value where required (e.g. 
shift table). Listings will include scheduled, unscheduled and retest data. 
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: 
 1 year = 365.25 days. Number of years is calculated as (days/365.25) rounded up to 1 
significant digit. 
 1 month = 30.4375 days. Number of months is calculated as (days/30.4375) rounded up to 1 
significant digit. 
 P-values will be rounded to 4 decimal places.  P-values that round to 0.0000 will be 
< 0.
-values that round to 1.000 wi
 
 
 Missing efficacy or safety data will not be imputed unless otherwise specified. 
 Time-to-event or duration of event endpoints will be based on the actual date the radiograph 
was obtained rather than the associated visit date. 


 
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 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. 
 For continuous endpoints, summary statistics will include n, mean, standard deviation, 
median, quartile 1(Q1), quartile 3(Q3), and range (minimum and maximum). 
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.  Specific 
rules for handling of missing or partially missing dates for prior/concomitant 
medications/procedures, subsequent anti-cancer therapies, adverse events, and deaths are 
provided in Appendix A.  
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 eCRF data and all derived 
values should be reviewed to ensure that the data is accurate and complete up to a pre-specified 
cutoff date.  Consistency checks and appropriate source data verification should be completed. 
6.3 
PATIENT CHARACTERISTICS 
6.3.1 
Patient Disposition 
The summary of patient disposition will be based on all patients enrolled.  The following patient 
disposition information will be summarized: 
 Number of enrolled patients  
 Number (%) of treated patients  
 Number (%) of treated patients who remain on treatment 
 Number (%) of treated patients who discontinue from treatment  
 Reasons that patients discontinue from treatment 
 Number (%) of treated patients who remain in study 
 Number (%) of treated patients who discontinue from study 


 
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 Reasons that patients discontinue from study 
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. Treatment follow-up time is defined as the time from the first dose 
date to the end of treatment date for patients discontinued from the treatment, or the database 
cutoff date for ongoing patients. Study and treatment follow-up time will be summarized 
descriptively. 
6.3.2 
Protocol Deviations 
Criteria for important protocol deviations will be established and patients with important 
protocol deviations will be identified and documented before the database lock. Important 
protocol deviations will be summarized for all patients in the Safety Analysis set. They will also 
be listed. 
6.3.3 
Demographic and Other Baseline Characteristics 
Demographic and baseline characteristics will be summarized descriptively for patients in the 
Safety Analysis set as follows: 
 Age (years) and age (years) categorized as <65, 65 and <75, and 75 years 
 Gender 
 Race 
 Ethnicity 
 Country 
 Baseline Eastern Cooperative Oncology Group ECOG) performance status 
 Baseline vital signs (height, weight, temperature, systolic blood pressure, diastolic blood 
pressure, heart rate) 
A listing of demographic will be provided. 
6.3.4 
Disease History and Characteristics 
The number (percentage) of patients reporting a history of disease and characteristic will be 
summarized for the Safety Analysis set. Disease characteristics include: 
 Time since first diagnosis of MZL to study entry (months) 
 Disease subtype (extranodal MZL of mucosa-associated lymphoid tissue (MALT), nodal 
MZL, or splenic MZL) 
 Disease status (relapsed or refractory) 
 Sites of disease (gastric, non-gastric/non-cutaneous, and cutaneous) for MALT subtype 
 Evidence of FDG avid disease by IRC 


 
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 Lymphoma involvement in the bone marrow 
 Number (%) of patients with prior radiotherapy  
 Time from the end of last radiotherapy to study entry (months) 
 Number (%) of patients with prior stem cell transplant  
A listing of disease history will be provided. 
6.3.5 
Prior Anti-Cancer Drug Therapies  
The following information related to prior anti-cancer therapy will be summarized for the Safety 
Analysis set: 
 Number (%) of patients with prior systematic therapy for cancer  
 Number of lines of prior therapies and number of lines of prior therapies categorized as 1, 2, 
3, etc.  
 Number of prior regimens and number of prior regimens categorized as 1, 2, 3, etc. 
 Number of prior regimens with CD20-directed therapy and number of prior regimens with 
CD20-directed therapy categorized as 1, 2, 3, etc. 
 Time from the end of last therapy to study entry (months) 
 Time from end of last disease progression to study entry (months) 
 Reason last therapy ended 
 Duration of last therapy (months) 
 Best overall response to last therapy 
 Prior treatment by regimen 
A listing of prior anti-cancer drug therapies will be provided. 
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 of the version currently in effect at Beigene at the time of 
database lock, and will be further classified to the appropriate Anatomical Therapeutic Chemical 
(ATC) code.   
The number (percentage) of patients reporting prior and concomitant medications will be 
summarized by ATC medication class and WHO DD preferred term for the Safety Analysis set. 
Prior medications will be defined as medications that started before the first dose of study drug. 
Concomitant medications will be 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 
 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 Appendix A will be used.  


 
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6.3.7 
Medical History 
Medical history will be mapped to a preferred term (PT) and a system organ class (SOC) using 
the Medical Dictionary for Regulatory Activities (MedDRA) of the version currently in effect at 
BeiGene at the time of database lock. The number (percentage) of patients reporting a history of 
any medical condition, as recorded on the CRF, will be summarized by SOC and PT for the 
Safety Analysis set.  
6.4 
EFFICACY ANALYSIS 
The set of primary interest for efficacy analyses is the Efficacy Analysis set.  
6.4.1 
Primary Efficacy Endpoint 
ORR by IRC 
The primary efficacy endpoint is ORR according to the Lugano Classification (Cheson et al 2014) 
as assessed by IRC.  ORR is defined as the proportion of patients achieving a best overall 
response of CR or PR. The point estimate and corresponding two-sided Clopper-Pearson 95% CI 
for ORR will be presented.  
The best overall response is defined as the best response recorded from the start of zanubrutinib 
throughout the study.  Patients with no post-baseline response assessment (due to any reason) 
will be considered non-responders for the purposes of this analysis. The proportion for each 
response category (CR, PR, stable disease [SD], and PD) will be presented. The primary efficacy 
analysis will be conducted when mature response rate data have been observed, estimated as no 
later than 12 months after the last patient received the first dose of study drug.   
6.4.2 
Secondary Efficacy Endpoints 
ORR by Investigator  
ORR by investigator is defined as the as the proportion of patients achieving a best overall 
response of CR or PR at any time on study drug assessed by investigator according to the 
Lugano Classification (Cheson et al 2014) and it will be analyzed using the same statistical 
methods as ORR by IRC. 
ORR using PET assessment in FDG-avid patients by IRC 
ORR accordance with the Lugano Classification (Cheson et al 2014) using PET assessment data 
for patients with FDG avid disease determined by IRC will be analyzed the same way as ORR 
by IRC. 
PFS by IRC 
PFS by IRC is defined as the time (months) from study treatment start to PD, as determined by 
IRC according to the Lugano Classification (Cheson et al 2014), or death of any cause, 
whichever occurs first: 
PFS = (the earlier of PD or death date  the date of first study dose +1)/30.4375 


 
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PFS will be right-censored based on rules provided in Table 1. The PFS censoring rule will 
follow FDA Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs 
and Biologics (FDA 2018). 
              Table 1. 
Censoring Rules for Analysis of Progression-Free Survival 
No. Situation 
Date of Progression or 
Censoring 
Outcome 
1 
No baseline and/or post-baseline 
disease assessments 
Date of the first dose  
Censored 
2 
Death or PD between planned disease 
assessments 
Date of death or first disease 
assessment showing PD, 
whichever occurs first 
Progressed 
3 
Alive without documented disease 
progression at the time of data cut-off 
or withdrawal from study (including 
lost-to-follow-up without disease 
progression) 
Date of last disease assessment  
Censored 
4 
New anticancer treatment started 
before documented disease 
progression or death 
Date of last disease assessment 
prior to date of new anticancer 
treatment 
Censored 
5 
Death before first disease assessment 
Date of death 
Progressed 
6 
Death or progression after more than 
one missed scheduled disease 
assessment 
Date of last disease assessment 
without documented disease 
progression before missed tumor 
assessments 
Censored 
 
Note that the frequency of disease assessments is about every 12 weeks in the first 48 weeks and 
every 24 weeks thereafter. Therefore, missing more than one disease assessment will be 
interpreted as gaps longer than 24 weeks in the first 96 weeks or gaps longer than 48 weeks 
thereafter for censoring purposes of PFS.     
Kaplan Meier methodology will be used to estimate the median and other quantiles of PFS. 
Kaplan Meier curves will be constructed to provide a visual description of the PFS change with 
time. Two-sided 95% CIs of median and other quartiles, if estimable, will be constructed with a 
generalized Brookmeyer and Crowley method (Brookmeyer 1982; Klein 1997) with log-log 
transformation. PFS rates at selected landmark time points (e.g. 6-month) will be provided with 
corresponding 95% CIs calculated based on the G
Kalbfleisch and Prentice 
1980) with log-log transformation. 
The duration of the follow-up for PFS will be determined by reverse Kaplan-Meier method 
(Schemper 1996).  


 
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PFS by Investigator 
PFS by investigator will be analyzed using the same statistical methods as PFS by IRC. 
OS 
OS is defined as the time (months) from study treatment start to death due to any cause. Patients 
who remain alive before data cutoff or discontinuation of the study (discontinued study due to 
reasons other t
 the time of data cutoff or the last date the patient 
is known to be alive. OS will be analyzed using the similar method as described for PFS. 
DOR by IRC 
DOR by IRC for responders (CR or PR) is defined as the time (months) from the date of the 
earliest qualifying response (PR or better) to the date of PD, as determined by IRC according to 
the Lugano Classification (Cheson et al 2014), or death for any cause, whichever occurs earlier.  
The censoring rules for DOR will follow the PFS censoring rules. Kaplan-Meier methods will be 
used to estimate median and other quartiles and 95% CIs for DOR.  Only responders will be 
included in this analysis. 
DOR by Investigator 
DOR by investigator will be analyzed using the same statistical methods as DOR by IRC. 
TTR by IRC 
TTR for responders (CR or PR) by IRC according to the Lugano Classification (Cheson et al 
2014) is defined as the time (months) from study treatment start to the date of the earliest 
qualifying response (PR or better) as determined by IRC. TTR by IRC will be summarized by 
sample statistics such as mean, median, and standard deviation for responders only.   
TTR by Investigator 
TTR by investigator will be analyzed using the same statistical methods as TTR by IRC. 
TTF 
TTF is defined as the time (months) from study treatment start to the date of discontinuation of 
study drug due to any reason. TTF will be censored at the data cutoff for the patients who don  
discontinue study treatment. The distribution of TTF will be summarized by the Kaplan-Meier 
method similarly as described for the PFS analysis.   
Time to Next Line of Therapy for MZL 
Time to next line of therapy is defined as the time (months) from study treatment start to the start 
of the first subsequent therapy for MZL. Time to next line of therapy for MZL will be censored 
as of date of study discontinuation or most recent contact date for patients who receive no 
subsequent therapy for MZL. Time to next line of therapy for MZL will be summarized by the 
Kaplan-Meier method similarly as described for the PFS analysis. 
       Table 2. Censoring Rules for Analysis of Time to Next Line of Therapy for MZL 


 
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Situation 
Date of Next Line of Therapy for MZL or 
Censoring 
Outcome 
Study discontinuation without any 
next line of therapy for MZL 
Date of study discontinuation 
Censored 
Administration of any next line of 
therapy for MZL (including 
radiotherapy)  
Date of first administration of next line of 
therapy for MZL  
Event 
No new administration of any next 
line of therapy for MZL  
Last day known alive 
Censored 
Patient-Reported Outcomes (PROs) 
The PROs questionnaires will be summarized on Cycle 1 Day 1, the end of Cycle 3, then every 
12 weeks for 12 months, followed by every 6 months thereafter, and will continue to be assessed 
until disease progression, death, or withdrawal of consent, regardless of study treatment 
discontinuation. The scoring of European Organization for Research and Treatment of Cancer 
Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and 5-level EQ-5D version (EQ-5D-5L) 
will follow their corresponding manuals (Fayers et al. 2001; EuroQol Group 1990; EuroQol 
Group 2015; Herdman et al 2011). 
 EORTC QLQ-C30 (version 3.0) 
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer 
patients which includes 30 separate questions (items) resulting in 1 Global Health Status/QoL 
scale, 5 functional scales (Physical Functioning, Role Functioning, Emotional Functioning, 
Cognitive Functioning, and Social Functioning), 3 symptom scales (Fatigue, Nausea and 
Vomiting, and Pain), and 6 single items (Dyspnea, Insomnia, Appetite Loss, Constipation, 
Diarrhea, and Financial Difficulties).   
The scores at each assessment timepoint and changes from baseline in Global Health Status/QoL 
scale, 5 functional scales, and 9 symptom scales/items will be summarized descriptively (e.g., 
mean, standard deviation, median, Q1, Q3, minimum, maximum).  
 EQ-5D-5L 
The EQ-5D-5L comprises a descriptive system for use as a measure of health outcome with 
following five dimensions: mobility, self-care, usual activities, pain/discomfort, and 
anxiety/depression, and an EQ Visual Analogue scale (EQ VAS). Each dimension has five 
levels: no problems, slight problems, moderate problems, severe problems, and extreme 
problems. The EQ VAS records the responden
-rated health on a 0 to 100 scale, with 100 
labe
alth you can im
 
worst health you can imagine .   
The number (%) of each level of all five dimensions at each assessment timepoint will be 
summarized. The VAS score at each assessment timepoint and changes from baseline will be 
summarized descriptively (e.g., mean, standard deviation, median, Q1, Q3, minimum, 
maximum). 


 
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6.4.3 
Subgroup Analyses 
Primary and selected secondary endpoints will be summarized descriptively in the specified 
subgroups, as appropriate (i.e., when there is sufficient number of patients in the subgroup, 
otherwise relevant subgroups may be combined): sex, age group (<65 vs. 65), ECOG 
performance status (0 
MZL 
, and MZL subtypes. 
Within-group summary statistics (e.g., ORR and medians for PFS, DOR with their 95% CIs) will 
be presented in forest plots. The subgroup variables and the cutoff values are subject to change if 
warranted to better represent the data.   
6.4.4 
Exploratory Efficacy Endpoints 
ORR (CR + CRu + PR) in accordance with Cheson 1999 as determined by IRC will be analyzed 
using the same methods as described for ORR by IRC. 
6.5 
PHARMACOKINETIC ANALYSES 
The analysis set for patients with PK samples will contain all patients who had at least one PK 
sample collected according to the protocol and laboratory manual.  
Actual collection times will be used for the calculation of PK parameters in the final analysis and 
reporting. For intensive PK profile, PK parameters such as Cmax, AUC0- , AUC0-t and half-life 
and other appropriate PK parameters after single and multiple doses will be derived using the 
standard non-compartmental method and will be computed in WinNonlin® Enterprise v.5.2 or 
higher.  Estimates for these parameters will be summarized (e.g., n, mean, standard deviation, 
coefficient of variation [CV%], median, min, max, geometric mean [GeoMean], and geometric 
coefficient of variation [GeoCV%]).   
For intensive PK data, individual and mean plasma zanubrutinib concentration-time data will be 
summarized and displayed in both tabular and graphical form. 
The following table lists PK parameters planned to be estimated.  Additional PK parameters may 
be calculated if deemed appropriate. 
AUC0-  
Area under the plasma concentration-time curve from zero to infinity 
AUC0-t 
Area under the plasma concentration-time curve from zero to t 
AUClast 
Area under the plasma concentration-time curve from zero to the last 
measurable concentration 
Cmax 
Maximum plasma concentration  
tmax  
Time to maximum plasma concentration  
t1/2 
Half life 
CL/F 
Apparent plasma clearance 
Vd/F 
Apparent volume of distribution 
 


 
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6.6 
SAFETY ANALYSES 
All safety analyses will be performed based on the Safety Analysis set.  
The incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs will be 
summarized. Laboratory test results, vital signs, and their changes from baseline will be 
summarized using descriptive statistics (e.g., n, mean, standard deviation, median, Q1, Q3, 
minimum, maximum for continuous variables; n [%] for categorical variables).  Abnormal values 
will be flagged.  
6.6.1 Extent of Exposure 
Extent of exposure to the study drug will be summarized descriptively with respect to the 
following:  
 Number of treatment cycles received: defined as the total number and percentage of 
treatment cycles in which at least one dose of the study drug is administered  
 Duration of exposure (months): defined as the duration (months) from the date of the first 
dose to the last dose of the study drug  
 Cumulative dose received per patient (g): defined as the cumulative dose (g) of the study 
drug during the treatment period of the study  
 Actual dose intensity (mg/day): defined as the total dose of the study drug (mg) received by a 
patient divided by the duration of exposure (days)  
 Relative dose intensity (%): defined as the ratio of the actual dose intensity (mg/day) and the 
planned dose intensity (mg/day), where the planned dose is (160*2) mg/day 
The number (percentage) of patients with dose modification (including reduction and 
interruption) will be summarized with the respective reasons. The cycles in which the first dose 
reduction/interruption occurs will be summarized. Frequency of dose reduction/interruption will 
be summarized descriptively. Duration of dose interruption (days) will be summarized 
descriptively. Patient data listings will be provided for all dosing records, and for the above 
calculated summary statistics. 
6.6.2 Adverse Events  
AEs will be graded by the investigators using NCI CTCAE v4.03 (NCI 2010). Verbatim 
description of AEs (as recorded by the investigator on the eCRF) will be classified into 
standardized PT and SOC using MedDRA. 
TEAE is defined as an AE that has an onset date or a worsening in severity from baseline (pre-
treatment) on or after the first dose of study drug and up to 30 days following study drug 
discontinuation, or the start of new anticancer therapy, whichever comes first. Only those AEs 
that are 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 considered by the investigator to be related to study 
drug or with missing assessment of the causal relationship. 


 
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An overview of patients with at least one TEAE will be presented with the incidence of: 
 Patients with at least 1 TEAE 
 Patients with at least 1 TEAE with grade 3 or higher  
 Patients with at least 1 Serious TEAE 
 Patients with at least 1 TEAE leading to death  
 Patients with at least 1 TEAE leading to treatment discontinuation 
 Patients with at least 1 TEAE leading to dose modification, including dose interruption 
and dose reduction 
 Patients with at least 1 treatment-related TEAE 
 Patients with at least 1 treatment-related TEAE with grade 3 or higher  
 Patients with at least 1 treatment-related Serious TEAE 
 Patients with at least 1 treatment-related TEAE leading to death  
 Patients with at least 1 treatment-related TEAE leading to treatment discontinuation 
 Patients with at least 1 treatment-related TEAE leading to dose modification, including 
dose interruption and dose reduction 
 Patients with TEAE of special interest 
The incidence of following TEAEs and Serious TEAEs will be reported by SOC and PT (and by 
worst grade if specified), sorted by decreasing frequency of SOC and PT (a patient with multiple 
occurrences of the same event within a SOC and PT will be counted only once by the worst 
grade according to CTCAE v4.03):   
 TEAE (any grade) by SOC/PT and by SOC/PT/worst grade 
 TEAE with grade 3 or higher by SOT/PT and by SOC/PT/worst grade 
 Serious TEAE by SOC/PT and by SOC/PT/worst grade  
 TEAE leading to death by SOC/PT 
 TEAE leading to treatment discontinuation by SOC/PT/worst grade 
 TEAE leading to treatment modification by SOC/PT/worst grade 
 Treatment-related TEAE by SOC/PT/worst grade  
 Treatment-related TEAE with grade 3 or higher by SOC/PT/worst grade 
 Treatment-related Serious TEAE by SOC/PT/worst grade  
 Treatment-related TEAE leading to death by SOC/PT 
 Treatment-related TEAE leading to treatment discontinuation by SOC/PT/worst grade 
 Treatment-related TEAE leading to treatment modification by SOC/PT/worst grade 


 
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The incidence of following TEAEs will be reported by PT: 
 TEAE (any grade) 
 TEAE with grade 3 or higher 
 Serious TEAE 
 TEAE leading to treatment discontinuation 
 TEAE leading to dose modification 
 TEAE leading to death 
 Treatment-related TEAE 
Incidence of and time to TEAEs of special interest such as 
grade 3 
bleed of any site or central nervous system bleed of any grade), and atrial fibrillation (both new 
onset and exacerbation of existing atrial fibrillation) will be summarized. Exposure adjusted 
incidence rate of TEAEs of special interest will be summarized as well. Incidence of TEAE 
related to liver, arrhythmia and diarrhea will be summarized.  
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.   
Listings of all AEs, treatment-related AE, grade 3 or above AEs, Serious AEs, AEs leading to 
treatment discontinuation, AEs leading to treatment modification, and AEs leading to death will 
be provided.  
6.6.3 Laboratory Values 
CBC and serum chemistry values will be evaluated for each laboratory parameter.  Abnormal 
laboratory values will be flagged and identified as those outside (above or below) the normal 
range. Descriptive summary statistics (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 provided by visit. 
Laboratory parameters that are graded in NCI-CTCAE (v.4.03) will be summarized by CTCAE 
grade. Shift tables will be used to assess the change of each laboratory parameter from its 
toxicity grade at baseline to the worst post-baseline toxicity grade including the unscheduled 
results. Parameters with CTCAE grading in both high and low directions (e.g., calcium, glucose, 
magnesium, phosphorus, potassium, sodium) will be summarized separately.  
A summary of patients with a change of 2 or more toxicity grade compared to baseline and 
patients with postbaseline toxicity grade of 3 or more will be provided for laboratory parameters 
of interest. Listings of selected laboratory parameters will be provided. 
6.6.4 Vital Signs 
Descriptive statistics for the actual values of vital signs parameters, including resting diastolic 
and systolic BP, heart rate, temperature, and weight, and changes from baseline will be presented  
by visit. Baseline vital signs will be listed by patient. 


 
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6.6.5 Electrocardiogram (ECG) 
A 12-lead electrocardiogram (ECG) will be performed locally in triplicate at screening for all 
patients and as clinically indicated at other timepoints. Number (percentage) of patients with 
postbaseline ECG parameters and change from baseline (if post-baseline ECG parameters are 
measured) categorized will be presented.  
6.6.6 Eastern Cooperative Oncology Group Performance Status (ECOG) 
ECOG performance status will be summarized as the number (percentage) of patients with each 
ECOG grade at the screening visit, each visit during study treatment, and at the Safety follow-up 
visit. Shift tables assessing the ECOG performance status at baseline versus worst performance 
status on study will be presented.  
6.7 
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. 
 
7 
INTERIM ANALYSIS 
No formal interim analyses are planned for this study.  Data from the study will be reviewed by 
the study monitoring committee on a periodic basis.  Summaries and analyses of subsets of the 
study data may be performed on a periodic basis for submission to professional meetings and for 
internal decision-making.  
 
8 
CHANGES IN THE PLANNED ANALYSIS 
Not applicable. 
 
 
 
 
 
 
 


 
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9 
REFERENCES 
1. Brookmeyer, B et al. (1982), A confidence interval for the median survival time, Biometrics 
38(1), p29-41.  
2. Cheson BD, Horning SJ, Coiffier B, et al. Report of an International Workshop to 
Standardize Response Criteria for Non-Hodgkin's Lymphomas. J Clin Oncol 1999; 17(4): 
1244. 
3. Cheson B, Fisher R, Barrington S, et al.  Recommendations for Initial Evaluation, Staging, 
and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano 
Classification. J Clin Oncol. 2014;32(27):3059-67. 
4. Cheson BD, Ansell S, Schwartz L, et al. Refinement of the Lugano Classification lymphoma 
response criteria in the era of immunomodulatory therapy. Blood. 2016;128(21):2489-2496. 
5. Common Toxicity Criteria Version 4.03. (2010) Cancer Therapy Evaluation Program. 
14 June 2010. 
6. EuroQol Group. EuroQol
a new facility for the measurement of health-related quality of 
life.  Health Policy. 1990;16(3):199-208. 
7. EuroQol Group. EQ-5D-5L User Guide: basic information on how to use the EQ-5D-5L 
instrument. 2015. https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-
5L_UserGuide_2015.pdf.  
8. Fayers P., Aaronson, NK, Bjordal K., Groenvold M., et al. 2001. EORTC QLQ-C30 Scoring 
Manual (3rd edition). (3rd ed.) Brussels: European Organization for Research and Treatment 
of Cancer. 
9. Food and Drug Administration Center for Drug Evaluation Research CDER and Center for 
Biologics Evaluation and Research (2018). FDA Guidance for Industry Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics.  
10. Herdman M, Gudex C, Lloyd A, et al.  Development and preliminary testing of the new five-
level version of EQ-5D (EQ-5D-5L). Quality of Life Research. 2011;20(10):1727-36.  
11. Kalbfleisch, J. D. and Prentice, R. L. (1980), The Statistical Analysis of Failure Time Data, 
New York: John Wiley & Sons.  
12. Klein, J. P. and Moeschberger, M. L. (1997), Survival Analysis: Techniques for Censored 
and Truncated Data, New York: Springer-Verlag. 
13. Noy A, de Vos S, Thieblemont C, et al. Targeting Bruton tyrosine kinase with ibrutinib in 
relapsed/refractory marginal zone lymphoma. Blood 2017;129(16):2224-32. 
14. Schemper M., and Smith T.L., (1996), A note on quantifying follow-up in studies of failure 
time, Controlled Clinical Trials, 17: 343-346. 
 


 
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10 
APPENDIX 
Appendix A: Missing Data Imputation Rule 
In general, missing or partial dates will not be imputed as data level. The following rules will 
apply for the specific analysis and summary purposes mentioned below only.   
A.1 Prior/Concomitant Medications/Therapies/Procedures 
When the start date or end date of a medication/therapy/procedure is partially missing, the date 
will be imputed to determine whether the medication/therapy/procedure is prior or concomitant. 
The following rules will be applied to impute partial dates for medications/therapies/procedures: 
If start date of a medication/therapy/procedure is partially missing, impute as follows: 
 If both month and day are missing, then set to January 01 
 If only day is missing, then set to the first of the month 
If end date of a medication/therapy/procedure is partially missing, impute as follows: 
 If both month and day are missing, then set to December 31 
 If only day is missing, then set to last day of the month 
If start date or end date of a medication/therapy/procedure is completely missing, do not impute. 
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: 
 If both month and day are missing and year = year of treatment start date, then set to 
treatment start date 
 If both month and day are missing and y
year of treatment start date, then set to 
January 01 
 If day is missing and month and year = month and year of treatment start date, then set to 
treatment start date 
 If day is missing a
t date, then set to 
first day of the month 
 If start date is completely missing, set to treatment start date as long as adverse event end 


 
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date is not before treatment start date 
If end date of an AE is partially missing, impute as follows: 
 If both month and day are missing, then set to December 31 
 If only day is missing, then set to last day of the month 
 If end date is completely missing, do not impute. 
If the imputed AE end date > last known alive date or end of study date, then set to the last 
known alive date or end of study date, whichever occurs first. 
 
A.3 Deaths 
In case only the day of a death date is missing, the death will be assumed to be on the 1st date of 
the month if the last date of patient known to be alive is earlier that the 1st date of the month, 
otherwise the death date will be assumed to be on 1 day after the last date of patient known to be 
alive. 
A.4 Subsequent Anti-cancer Therapies 
If the start date of a subsequent anti-cancer therapy is missing, the start date will be assumed to 
be on the 1st date of the month. 


 
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Appendix B: Specification on the Use of Lab Data  
For determination of baseline value and for the summary of lab parameter at each scheduled visit 
and the change from baseline, following rule will be applied: 
if a patient has either non-missing local or central lab parameter value only, that value will be 
treated as baseline value; if a patient has both non-missing local and central lab parameter 
values, the central lab parameter value will be used over the local one. 
For the shift table of the summary of the worst post-baseline grade from baseline, it will be based 
on all data (both local and central) at all post-baseline visits (including unscheduled visits). 
If the lab parameter has a missing unit at a visit, it will be not used in the related summary 
analysis.