Clinical trial NCT03493451
Conditions: Peripheral T Cell Lymphoma PTCL Extranodal NK/T-cell Lymphoma Extranodal NK/T-cell Lymphoma, Nasal Type Extranodal NK T Cell Lymphoma Extranodal NK T Cell Lymphoma, Nasal Adult Nasal Type Extranodal NK/T-cell Lymphoma Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic T-Cell Lymphoma Recurrent Angioimmunoblastic T-Cell Lymphoma Refractory Peripheral T-cell Lymphoma NOS Peripheral T-Cell Lymphoma, Not Otherwise Specified Peripheral T-Cell Lymphoma Refractory Anaplastic Large Cell Lymphoma Anaplastic Large Cell Lymphoma, ALK-Positive Anaplastic Large Cell Lymphoma, ALK-negative ALK-negative Anaplastic Large Cell Lymphoma ALK-Positive Anaplastic Large Cell Lymphoma Cutaneous T-cell Lymphoma
Keywords: T/NK-cell NK/T-cell extranodal nasal NK-cell ENKTL peripheral T-cell anaplastic large cell ALCL angioimmunoblastic PTCL-NOS Relapsed Refractory
Sponsor: BeiGene
Start date: 2018-04-13; Completion date: 2021-04-21
Enrollment: 77 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a multi-center, prospective, non-randomized, open-label, Phase 2 clinical study to evaluate the safety and efficacy of BGB-A317 in participants with relapsed or refractory mature T- and natural killer (NK)-cell neoplasms. There were three cohorts:

* Cohort 1: Relapsed or refractory (R/R) extranodal NK/T cell lymphoma (ENKTL; nasal or non-nasal type)
* Cohort 2: Other R/R mature T-cell neoplasms, limited to the following histologies: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or anaplastic large-cell lymphoma (ALCL)
* Cohort 3: R/R cutaneous T-cell lymphoma, limited to mycosis fungoides (MF) or Sèzary syndrome (SS)

Study procedures included a Screening phase (up to 35 days); Treatment phase (until disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs first); Safety Follow-up phase (up to 90 days following last study treatment for all adverse events (AEs) and serious adverse events (SAEs)); and Survival follow-up phase (duration varying by participant).

Detailed description:

Arms: arm 1: Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) arm 2: Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) arm 3: Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle)
Interventions: intervention 1: Tislelizumab
Intervention descriptions: intervention 1: Administered intravenously

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 
BeiGene USA, Inc
BGB-$317-207 
  (Statistical Analysis Plan) 
Version 1.0:  07-Jan-2020 
Page 1 of 27
CONFIDENTIAL
STATISTICAL ANALYSIS PLAN 
Study Protocol 
Number: 
BGB-A317-207 
Study Protocol 
Title: 
A Phase 2, Open-Label Study of tislelizumab in Patients with Relapsed 
or Refractory Mature T- and NK-cell Neoplasms 
Date: 
07-Jan-2020 
Version: 
1.0 
1&7


BeiGene USA, Inc
                  BGB-$317-207
              (Statistical Analysis Plan)
Version 1.0:  07-Jan-2020
Page 2 of 27
CONFIDENTIAL
SIGNATURE PAGE
Authors: 
 
  
BeiGene Co., Ltd.
Approval
BeiGene Co., Ltd.
BeiGene Co., Ltd.


 
BeiGene USA, Inc
                  BGB-$317-207 
              (Statistical Analysis Plan) 
 
 
 
Version 1.0:  07-Jan-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 
12 
6 
STATISTICAL METHODS 
13 
6.1 
Data Analysis General Considerations 
13 
6.1.1 
Definitions and Computations 
13 
6.1.2 
Conventions 
13 
6.1.3 
Handling of Missing Data 
14 
6.1.4 
Adjustment for Covariates 
14 
6.1.5 
Multiplicity Adjustment 
14 
6.1.6 
Data Integrity 
14 
6.2 
Analysis sets 
14 
6.3 
Patient Characteristics 
14 
6.3.1 
Patient Disposition 
14 
6.3.2 
Protocol Deviations 
15 
6.3.3 
Demographic and Other Baseline Characteristics 
15 
6.3.4 
Disease History and Characteristics 
15 
6.3.5 
Prior Anti-Cancer Therapies 
15 
6.3.6 
Prior and Concomitant Medications 
15 
6.3.7 
Medical History 
16 
6.4 
Efficacy Analysis 
16 
6.4.1 
Primary Efficacy Endpoint 
16 
6.4.2 
Secondary Efficacy Endpoints 
16 
6.4.3 
Subgroup Analyses 
18 
6.4.4 
Exploratory Efficacy Endpoints 
19 
6.5 
Pharmacokinetic Analyses 
19 
6.6 
Safety Analyses 
19 
6.6.1 
Extent of Exposure 
19 
6.6.2 
Adverse Events 
20 
6.6.3 
Laboratory Values 
22 
6.6.4 
Vital Signs 
23 
6.6.5 
Electrocardiogram (ECG) 
23 


 
BeiGene USA, Inc
                  BGB-$317-207 
              (Statistical Analysis Plan) 
 
 
 
Version 1.0:  07-Jan-2020 
Page 4 of 27
CONFIDENTIAL
 
6.6.6 
ECOG 
23 
6.7 
Other Analyses 
23 
6.7.1 
Immunogenicity Analyses 
23 
7 
INTERIM ANALYSIS 
23 
8 
CHANGES IN THE PLANNED ANALYSIS 
24 
9 
REFERENCES 
25 
10 
APPENDIX 
26 
Appendix A: 
Missing Data Imputation Rule 
26 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
BeiGene USA, Inc
                  BGB-$317-207 
              (Statistical Analysis Plan) 
 
 
 
Version 1.0:  07-Jan-2020 
Page 5 of 27
CONFIDENTIAL
 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Term 
ADI 
Actual dose intensity 
AE 
Adverse event 
AITCL 
Angioimmunoblastic T-cell lymphoma 
ATC 
Anatomical Therapeutic Chemical 
ALCL 
Anaplastic large cell lymphoma 
CI 
Confidence interval 
CR 
Complete response 
CTCAE 
Common Terminology Criteria for Adverse Events 
Ctrough 
Lowest concentration reached before the next dose administered 
DOR 
Duration of response 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
EBV 
Epstein Barr Virus 
EBER 
Epstein Barr virus-encoded small RNA 
EORTC QLQ-C30 
European Organization for Research and Treatment of Cancer 
Quality of Life Questionnaire C30 
EQ-5D-5L 
5-level EQ-5D version 
eCRF 
Electronic case report form 
irAE 
Immune-related adverse event 
ISH 
In situ hybridization 
ISCL/EORTC 
International Society for Cutaneous Lymphomas/European 
Organization of Research and Treatment of Cancer  
LYRIC 
Lymphoma response to immunomodulatory therapy criteria 
MedDRA 
Medical Dictionary for Regulatory Activities 
MF 
Mycosis Fungoides 
NCI 
National Cancer Institute 
ORR 
Overall response rate 
OS 
Overall survival 
PD 
Progressive disease 
PD-L1 
Programmed cell death protein ligand-1 
PK 
Pharmacokinetic  
PFS 
Progression-free survival 
PR 
Partial response 


 
BeiGene USA, Inc
                  BGB-$317-207 
              (Statistical Analysis Plan) 
 
 
 
Version 1.0:  07-Jan-2020 
Page 6 of 27
CONFIDENTIAL
 
PT 
Preferred term 
PTCL-NOS 
Peripheral T-cell lymphoma - not otherwise specified 
RDI 
Relative dose intensity 
Serious TEAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SOC 
System Organ Class 
SS 
Sèzary Syndrome 
TEAE 
Treatment-emergent adverse event 
TTR 
Time to response 
WHO DD 
World Health Organization Drug Dictionary 
 


 
BeiGene USA, Inc
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1 
INTRODUCTION 
The purpose of this statistical analysis plan (SAP) is to describe the procedures and the statistical 
methods that will be used to analyze and report results for the protocol BGB-A317-207 
amendment 3.0 dated 1-Mar-2019 titled: A Phase 2, Open-Label Study of tislelizumabin Patients 
with Relapsed or Refractory Mature T- and NK-cell Neoplasms. 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, prospective, non-randomized, open-label, phase 2 clinical study to 
evaluate the safety and efficacy of tislelizumab in patients with relapsed or refractory mature T-
cell and NK-cell neoplasms.  There will be three cohorts of patients: Cohort 1: patients with 
relapsed or refractory extranodal NK/T cell lymphoma; Cohort 2: patients with other mature T-
cell neoplasms, limited to the following histologies; peripheral T-cell lymphoma - not otherwise 
specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITCL), and anaplastic large 
cell lymphoma (ALCL); and Cohort 3: patients with cutaneous T cell lymphomas, limited to 
Mycosis Fungoides (MF) or Sèzary Syndrome (SS), stage IB or higher.  Approximately 70 
patients will be enrolled into Cohort 1, 50 patients into Cohort 2, and 10 patients into Cohort 3 
for a total sample size of up to 130 patients.  Cohort 2 will include up to 20 patients with PTCL-
NOS, up to 10 with AITCL, and up to 20 with ALCL.  Cohort 3 will be available for accrual 
only in North America (U.S. and Canada) and in the EU (Italy, France, and Germany).  EBV 
status in Cohorts 1 and 2 will be determined by EBV-encoded RNAs (EBER) in situ 
hybridization (ISH) from local pathology report or, if not previously performed, testing from 
archival or fresh tumor tissue.  For C
will be recorded if their local pathology report includes available EBV testing. Enrollment will 
be held for the following: 
 Cohort 1: patients with relapsed or refractory extranodal NK/T cell lymphoma (nasal or 
non-nasal type) 
 Cohort 2: patients with other mature T-cell neoplasms, limited to the following 
histologies: PTCL-NOS, AITCL, ALCL 
 Cohort 3: patients with cutaneous T cell lymphomas, limited to MF or SS, stage IB or 
higher 
Tislelizumab will be administered intravenously as a 200-mg infusion every three weeks. The 
primary efficacy endpoint is overall response rate (ORR) determined by investigator. Disease 
response for the primary endpoint for Cohorts 1 and 2 will be assessed per the Lugano criteria 
(Cheson et al 2014) with the Lymphoma Response to Immunomodulatory Therapy Criteria 
(LYRIC) modification for immunomodulatory therapy (Cheson et al 2016). Disease response for 
Cohort 3 for the primary endpoint will be assessed per International Society for Cutaneous 
Lymphomas/European Organization of Research and Treatment of Cancer (ISCL/EORTC) 
guidelines (Olsen et al 2011).  
The study procedures will occur over a screening phase (up to 35 days); treatment phase (until 
disease progression, intolerable toxicity, or withdrawal of informed consent, whichever occurs 
first); safety follow-up phase (up to 90 days following last study treatment for all AEs and 


 
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Serious TEAEs; and a survival follow-up phase (duration varying by patient). 
Study treatment must commence within 5 days after screening assessments have been completed 
and study eligibility has been determined.  
Each cycle consists of 21 days. 
 
Figure 1 
Schema for Study BGB-A317-207 
 
 
 
 
 


 
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3 
STUDY OBJECTIVES 
3.1 
PRIMARY OBJECTIVES  
 To evaluate efficacy, as measured by ORR and determined by investigator  
3.2 
SECONDARY OBJECTIVES  
 To evaluate efficacy, as measured by the following and determined by investigator: 
o Duration of response (DOR) for all cohorts  
o Progression-free survival (PFS) for all cohorts  
o Overall survival (OS) for Cohorts 1 and 2 
o Rate of complete response (CR) or complete metabolic response for all cohorts 
o Time to response (TTR) for all cohorts  
o Patient-reported outcomes (EQ-5D-5L and EORTC QLQ-C30) for all cohorts 
 To evaluate the safety and tolerability of tislelizumab for all cohorts 
3.3 
EXPLORATORY OBJECTIVES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
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4 
STUDY ENDPOINTS 
4.1 
PRIMARY ENDPOINTS 
The primary endpoint is ORR. ORR is defined as the proportion of patients achieving a best 
overall response of either complete response (CR) or partial response (PR).  Best overall 
response is defined as the best response recorded from the start of tislelizumab to the end of the 
best response determination period.  Patients with no post-baseline response assessment will be 
considered non-responders.  Efficacy will be assessed every 12 weeks for 96 weeks, then every 
24 weeks for an additional 96 weeks, and then yearly until disease progression. 
 For Cohorts 1 and 2, ORR will be measured using the Lugano criteria (Cheson et al 
2014) with LYRIC modification for immunomodulatory drugs (Cheson et al 2016) and 
determined by investigator 
 For Cohort 3, ORR will be measured using the ISCL/EORTC guidelines (Olsen et al 
2011) and determined by investigator 
4.2 
SECONDARY ENDPOINTS 
For Cohorts 1 and 2, efficacy measures will be determined using the Lugano criteria (Cheson et 
al 2014) with LYRIC modification for immunomodulatory drugs (Cheson et al 2016). For 
Cohort 3, efficacy measures will be determined using the ISCL/EORTC guidelines (Olsen et al 
2011). All measures will be assessed by investigator. 
 DOR defined as the time from the first determination of an objective response until 
disease progression or death, whichever occurs first, for all cohorts  
 PFS defined as the time from first study drug administration to the date of disease 
progression or death, whichever occurs first, for all cohorts 
 OS, defined as the time from first study drug administration to the date of death due to 
any reason, for Cohorts 1 and 2 
 Rate of CR or complete metabolic response defined as the proportion of patients who 
achieve CR or complete metabolic response as best overall response, for all cohorts 
 TTR defined as the time from first study drug administration to the time the response 
criteria (CR or PR) are first met, for all cohorts 
 Patient-reported outcomes measured by EORTC QLQ-C30 and EQ-5D-5L questionnaires 
for all cohorts 
 Safety parameters, including AEs, Serious TEAEs, clinical laboratory tests, physical 
exams, electrocardiograms, ophthalmologic examination, and vital signs for all cohorts 
4.3 
EXPLORATORY ENDPOINTS 
 
 
 
 
 


 
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5 
SAMPLE SIZE CONSIDERATIONS 
The sample size is based on the precision of the estimates of the ORR. With 10, 20, 50 and 70 
subjects in one cohort/subtype, if the observed ORR is 30%, the corresponding Clopper-Pearson 
95% CIs are as follows: 10 subjects (6.67%, 65.25%); 20 subjects (11.89%, 54.28%); 50 subjects 
(17.86%, 44.61%); and 70 subjects (19.62%, 42.13%).  
A more detailed list of tables with ORR and corresponding Clopper-Pearson 95% CIs for several 
potential outcomes under assumed cohort/subtype sample sizes are provided below.  
Sample Size
Observed Responses 
ORR 
95% CI 
10 
2 
20% 
2.52% 
55.61% 
10 
3 
30% 
6.67% 
65.25% 
10 
4 
40% 
12.16% 
73.76% 
10 
5 
50% 
18.71% 
81.29% 
10 
6 
60% 
26.24% 
87.84% 
 
Sample Size
Observed Responses 
ORR 
95% CI 
20 
4 
20% 
5.73% 
43.66% 
20 
6 
30% 
11.89% 
54.28% 
20 
8 
40% 
19.12% 
63.95% 
20 
10 
50% 
27.20% 
72.80% 
20 
12 
60% 
36.05% 
80.88% 
 
Sample Size
Observed Responses 
ORR 
95% CI 
50 
10 
20% 
10.03% 
33.72% 
50 
15 
30% 
17.86% 
44.61% 
50 
20 
40% 
26.41% 
54.82% 
50 
25 
50% 
35.53% 
64.47% 
50 
30 
60% 
45.18% 
73.59% 
 
Sample Size
Observed Responses 
ORR 
95% CI 
70 
14 
20% 
11.39% 
31.27% 
70 
21 
30% 
19.62% 
42.13% 
70 
28 
40% 
28.47% 
52.41% 
70 
35 
50% 
37.80% 
62.20% 
70 
42 
60% 
47.59% 
71.53% 
 


 
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6 
STATISTICAL METHODS 
6.1 
DATA ANALYSIS GENERAL CONSIDERATIONS 
All analyses except for efficacy analyses will be performed by cohort and combined. 
Efficacy analyses will be performed by cohort and further by subtype in Cohorts 2 and 3 if data 
permit. 
6.1.1 
Definitions and Computations 
Study drug: the study drug in this study is tislelizumab. 
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. 
6.1.2 
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 
decimal place. 
 1 month = 30.4375 days. Number of months is calculated as (days/30.4375) rounded up 
to 1 decimal place. 
 Age will be calculated as the integer part of (date of informed consent  date of birth + 
1)/365.25 
 P-values will be rounded to 4 decimal places.  P-values that round to 0.0000 will be 
 
-values that round to 1.000 will be presente
 0.9999    
 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. 
 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. 


 
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 For continuous endpoints, summary statistics will include n, mean, standard deviation, 
median, Q1, Q3, and range (minimum and maximum). 
6.1.3 
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 detailed 
in Appendix A. 
By-visit summary of variables with missing data will use only non-missing data, not imputed 
one, unless otherwise specified.  
6.1.4 
Adjustment for Covariates 
Not applicable. 
6.1.5 
Multiplicity Adjustment 
Not applicable.  
6.1.6 
Data Integrity 
Before any pre-specified statistical analysis begins, the integrity of the data 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 complete. 
6.2 
ANALYSIS SETS 
The Safety analysis set includes all patients who received at least one dose of tislelizumab. It will 
be the primary analysis set for both efficacy and safety analyses. 
The PK analysis set includes all treated patients for whom at least one PK sample is collected 
according to the protocol and laboratory manual. 
6.3 
PATIENT CHARACTERISTICS  
6.3.1 
Patient Disposition 
The number (percentage) of patients enrolled, treated, discontinued from study drug and those 
with important protocol deviations will be counted. The primary reason for study drug 
discontinued will be summarized according to the categories in the eCRF.  
The end of study status (alive, deceased, withdrew consent or lost to follow-up) at the data cutoff 
date will be summarized using the data from the eCRF. 
Survival status (alive, deceased or lost to follow-up) at the data cutoff date will be summarized 
using the data from the survival follow-ups. 
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 summarized descriptively. 


 
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6.3.2 
Protocol Deviations 
Important protocol deviation criteria 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 
by category. 
6.3.3 
Demographic and Other Baseline Characteristics 
Demographic and other baseline characteristics will be summarized in Safety analysis set using 
descriptive statistics. Continuous variables include age, weight, height, and BMI; Categorical 
variables include sex, 
), race, country, and ECOG performance status. 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, as recorded 
on the CRF, will be summarized in Safety analysis set. Disease characteristics include time from 
first diagnosis of underlying disease to study entry (in months), disease subtype, disease status 
(relapse, refractory), disease stage at study entry, mSWAT score for cohort 3 at study entry, EBV 
by EBER-ISH status, bone marrow involvement at study entry, B-symptom at study entry, LDH 
at study entry, and lymphocytes count at study entry. The number (percentage) of patients with 
prior radiotherapy, the time from end of last therapy to study entry (in months) and the number 
(percentage) of patients with prior autologous stem cell transplant will be summarized. A listing 
of disease history will be provided.  
6.3.5 
Prior Anti-Cancer Therapies  
The number (percentage) of patients with prior systemic therapy, the number of prior regimen, 
the reason why the last regimen ended, time from the end of last regimen to study entry (in 
months), duration of last regimen (in months), best overall response to last regimen, time from 
end of last progressive disease to study entry (in months), and prior L-asparagine usage will be 
summarized. The therapies with the same regimen are counted as one prior therapy. Summary of 
prior non-systemic therapy for cohort 3 may be conducted. A listing of prior anti-cancer 
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 name in the Safety analysis set. 
Prior medications are defined as medications that started before the first dose date. 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 patient  last dose.  


 
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6.3.7 
Medical History 
Medical History will be coded using MedDRA codes 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 system organ class (SOC) 
and preferred term (PT) in the Safety analysis set. 
6.4 
EFFICACY ANALYSIS 
All efficacy analyses will be based on the Safety analysis set.  
6.4.1 
Primary Efficacy Endpoint 
ORR by Investigator (All cohorts) 
The primary efficacy endpoint is ORR determined by investigator using the Lugano criteria 
(Cheson et al 2014) with LYRIC modification for immunomodulatory drugs (Cheson et al 2016) 
for Cohorts 1 and 2 and using the ISCL/EORTC guidelines (Olsen et al 2011) for Cohort 3. 
The point estimates of ORR and corresponding Clopper-Pearson 95% CIs will be presented. 
The proportion for each response category (CR, PR, SD, and progressive disease (PD)) of the 
best overall response will be presented. 
The primary efficacy analysis for each cohort will be conducted when mature response rate data 
have been observed, estimated as no later than 12 months after the last patient in each cohort 
received the first dose of study drug.  
6.4.2 
Secondary Efficacy Endpoints 
PFS by Investigator (All cohorts) 
PFS is defined as the time (in weeks) from the date of first study dose to 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)/7. 
PFS will be right-censored based on rules provided in Table 1 below.  These conventions are 
modified based on the 2018 FDA Guidan
inical Trial Endpoints for the 
FDA Guidance for Industry 2018). 
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 quantiles, 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% confidence intervals calculated based on the G
ormula 
(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). 
Note that the frequency of disease assessments is every 12 weeks in the first 96 weeks and every 
24 weeks for additional 96 weeks, and then yearly until disease progression. Therefore, missing 


 
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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.     
              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 
 
DOR by Investigator (All cohorts) 
DOR for responders (CR or PR) is defined as the time (in weeks) from the date when the 
response criteria were first met (PR or better) to the date that disease progression is objectively 
documented or death, whichever occurs first. Censoring rule for DOR will follow PFS censoring 
rule. DOR will be analyzed using the same method as described for PFS if data allows. Only 
responders will be included in this analysis.  
OS (Cohorts 1 and 2) 
OS is defined as the time (in weeks) from the date of first study dose to death due to any cause. 
Patients who remained alive before data cutoff or discontinuation of the study (discontinued 
study due to reasons oth
a
censored at the time of data cutoff or the last 
date the patient was known to be alive. OS will be analyzed using the same method as described 
for PFS, except the censoring criteria. 
CR/Complete Metabolic Response by Investigator (All cohorts) 


 
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CR rate and complete metabolic response rate will be calculated as the proportion of patients 
whose best overall response is CR or complete metabolic response, respectively.  CR/complete 
metabolic response rate will be analyzed using same method applied on ORR.  
TTR by Investigator (All cohorts) 
TTR for responders (CR or PR) is defined as the time from the first dose to the date of the 
earliest qualifying response (PR or better). TTR will be summarized by sample statistics such as 
mean, median and standard deviation for responders only.   
Patient-Reported Outcomes 
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 
-rated health on a 0 to 100 scale, with 100 
 
The number (percentage) 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). 
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), race, 


 
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country/region (APAC vs. non-APAC), and ECOG-performance status (0 vs. 
1). Within group 
values (ORR, medians for PFS 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 
 
    
 
   
 
6.5 
PHARMACOKINETIC ANALYSES 
All PK analyses will be performed based on the PK analysis set. Tislelizumab post-dose and 
trough serum concentration data (Ctrough) will be tabulated and summarized by visit/cycle at 
which these concentrations are collected.  Descriptive statistics will include n, mean, coefficient 
of variation, standard deviation, median, min, max, geometric mean, and geometric coefficient of 
variation.  
Additional PK analyses, including population PK analyses and exposure-response (efficacy, 
safety endpoints) analyses may be conducted as appropriate and the results of such analysis may 
be reported separately from the Clinical Study Report.   
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 treatment-emergent 
adverse events (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 
The tislelizumab dose information of each patient will be described as follows:  
 Number of treatment cycles received  
 Duration of exposure (in weeks) is defined as:  


 
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      (date of last dose of tislelizumab + 21 days  date of first dose of tislelizumab)/7 
 Cumulative dose (in g): the sum of all actual doses of tislelizumab, given from first to last 
administration  
 Actual dose intensity (ADI) (in mg/week) is defined as:  
      Cumulative dose (in mg) / Duration of exposure (in weeks) 
 Relative dose intensity (RDI) (%) is defined as:  
      
(mg/week)
Intensity 
 
Dose
 
Planned
 
(mg/week)
 
ADI
100
 
      where Planned dose intensity equals to (200/3) mg/week. 
All above extent to exposure variables will be summarized descriptively. 
The following analyses will be performed to describe tislelizumab dose modifications: 
 The number (percentage) of patients with dose interruption/dose delay and the primary 
reason (e.g., due to AEs) will be summarized 
 Frequency of dose interruptions/dose delay per patient will be summarized descriptively 
 The cycle in which the first dose interruption/dose delay occurred will be summarized  
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 Common Terminology Criteria for Adverse Events 
(CTCAE) v4.03. The AE verbatim descriptions (investigator terms from the CRF) will be 
classified into standardized PT and SOC using the Medical Dictionary for Regulatory Activities 
(MedDRA).   
TEAE is defined as an AE that had an onset date or a worsening in severity from baseline (pre-
treatment) on or after the first dose of study drug up to 30 days following study drug 
discontinuation or initiation of a new anticancer therapy. TEAEs also include all irAEs and drug-
related serious AEs recorded up to 90 days after the last dose of study drug, regardless of 
whether or not the patient starts a new anticancer therapy. 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 considered by the investigato
la
 or with 
missing assessment of the causal relationship.  
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  


 
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 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 delay 
 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 delay  
 Patients with at least 1 irTEAE   
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 SOC/PT/worst grade 
 TEAE leading to treatment discontinuation by SOC/PT/worst grade 
 TEAE leading to treatment modification (interruption or delay) by SOC/PT/worst grade 
 TEAE leading to death by SOC/PT 
 Serious TEAE by SOC/PT and by SOC/PT/worst grade  
 Treatment-related TEAE by SOC/ PT/worst grade 
 Treatment-related Serious TEAE by SOC/PT/worst grade 
 Treatment-related grade 3 or higher by SOC/PT/worst grade 
 Treatment-related TEAE leading to treatment discontinuation by SOC/PT/worst grade 
 Treatment-related TEAE leading to treatment modification (interruption or delay) by 
SOC/PT/worst grade 
 Treatment-related TEAE leading to death by SOC/PT 
The incidence of following TEAEs will be reported by PT, in descending order: 
 TEAE (any grade) 


 
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 Serious TEAE 
 TEAE leading to treatment discontinuation 
 TEAE leading to dose modification 
 TEAE leading to death 
 irTEAE 
Other specific summary of AE will be conducted:  
 irTEAE by PT and time interval. 
 irTEAE by category/PT 
 Grade 3 or higher irTEAE by category/PT 
 irTEAE leading to discontinuation by category/PT 
 irTEAE leading to dose modification by category/PT 
 irTEAE leading to death by category/PT 
 irTEAE leading to steroid treatment by category/PT 
 irTEAE leading to hormone replacement treatment by category/PT 
 Infusion related reaction by SOC/PT/worst grade 
All deaths and deaths within/beyond 90 days of last dose date and the causes of death will be 
summarized, including those occurred during the study treatment period and those reported 
during the survival follow-up period after treatment discontinuation. 
Listings of all AEs, treatment-related AE, grade 3 or above AEs, Serious AEs, AEs leading to 
treatment discontinuation, AE leading to dose modification, AEs leading to death, and irTEAE 
will be provided. 
6.6.3 Laboratory Values 
CBC and serum chemistry values will be evaluated for each laboratory parameter by cohort and 
combined.  Abnormal laboratory values will be flagged and identified as those outside (above or 
below) the normal range.  Reference (normal) ranges for laboratory parameters will be included 
in the Clinical Study Report.   
Descriptive summary statistics (n, mean, standard deviation, median, Q1, Q3, minimum, 
maximum for continuous variables; n [%] for categorical variables) for selected laboratory 
parameters by visit/cycle and changes from baseline will be provided. 
Laboratory parameters that are graded in National Cancer Institute (NCI) CTCAE (v.4.03) will 
be summarized by CTCAE grade. Shifts tables will be used to assess the change of each 
laboratory parameter from baseline toxicity grade to the worst post-baseline toxicity grade. In the 
summary of laboratory parameters by CTCAE grade, parameters with CTCAE grading in both 
high and low directions will be summarized separately.  


 
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A summary of patients with an increase 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 with grade 3 or higher will be provided. 
6.6.4 Vital Signs 
Descriptive statistics for vital sign parameters (e.g., systolic and diastolic BP, heart rate, 
temperature) and changes from baseline will be presented by visit.  Vital signs will be listed by 
patient and visit. 
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. Descriptive statistics for ECG parameters 
by visit and change from baseline (if post-baseline ECG parameters are measured) will be 
presented.  
6.6.6 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 post-baseline 
performance status on study will be presented.   
6.7 
OTHER ANALYSES 
6.7.1 
Immunogenicity Analyses  
Samples to assess anti-tislelizumab antibodies will be collected. 
The immunogenicity results may be summarized using descriptive statistics by the number and 
percentage of patients who develop detectable ADA.  The incidence of positive ADA and 
neutralizing ADA may be reported for evaluable patients.  The effect of immunogenicity on PK, 
efficacy, and safety may be evaluated if data allow.  
 
7 
INTERIM ANALYSIS 
No formal interim analysis is planned. Enrollment will be held if no confirmed tumor responses 
are seen in the first 10 evaluable patients for Cohort 1 and in the first 10 evaluable patients for 
Cohort 2 subtypes of PTCL-NOS and ALCL, respectively, until the study Steering Committee 
can meet with the sponsor to discuss the risk/benefit ratio and make a joint decision to determine 
whether enrollment will be permanently discontinued in Cohort 1 or subtype(s), based on the 
overall available data. If there is only one single confirmed tumor response among the first 10 
evaluable patients for Cohort 1 or Cohort 2 subtypes of PTCL-NOS and ALCL, respectively, the 
Study Steering Committee and sponsor may also meet to discuss the risk/benefit ratio and 
determine whether it is appropriate to resume enrollment. If more than one confirmed tumor 
response is seen in the first 10 patients enrolled in Cohort 1 or subtype(s), then enrollment of 
patients may resume. 


 
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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 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. 
3. 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. 
4. Common Toxicity Criteria Version 4.03. (2010) Cancer Therapy Evaluation Program. 
14 June 2010. 
5. EuroQol Group. EuroQol
a new facility for the measurement of health-related quality 
of life.  Health Policy. 1990;16(3):199-208. 
6. 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.  
7. 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. 
8. 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.  
9. 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.  
10. Kalbfleisch, J. D. and Prentice, R. L. (1980), The Statistical Analysis of Failure Time 
Data, New York: John Wiley & Sons.  
11. Klein, J. P. and Moeschberger, M. L. (1997), Survival Analysis: Techniques for Censored 
and Truncated Data, New York: Springer-Verlag. 
12. 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 
 For prior anticancer therapy, the imputed end date should be the first dose date  14 at the 
latest after imputation. 
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 as long as adverse event end date is not before treatment start date 
 If both month and day are missing an
e, 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 as long as adverse event end date is not before treatment start date 
 If day is mis


 
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first day of the month 
 If start date is completely missing, set to treatment start date as long as adverse event end 
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 subject 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 subject 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.