Clinical trial NCT04762160
Conditions: Follicular Lymphoma
Keywords: follicular lymphoma relapse follicular lymphoma refractory follicular lymphoma rituximab tazemetostat
Sponsor: Epizyme, Inc.
Start date: 2020-12-15; Completion date: 2022-03-22
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the safety and efficacy of combining the EZH2 inhibitor tazemetostat with rituximab in R/R FL subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used.

Detailed description:
This is a phase 2, multicenter, open-label study of oral tazemetostat in combination with rituximab in subjects with relapsed or refractory (R/R) follicular lymphoma (FL). This study is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab in subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used, and used and features early futility stopping to maintain subject safety.

Arms: arm 1: Tazemetostat 800 mg BID is administered daily starting on Cycle 1 Day 1 (C1D1). Tazemetostat will be administered from C1D1 to the end of Cycle 24, for 24 months of therapy or until disease progression, unacceptable toxicity, or withdrawal of consent. Rituximab will be administered by either subcutaneous injection or IV infusion according to the regional product prescribing information, labeling and institutional guidelines. Rituximab will be administered at a dose of 375 mg/m2 on Day 1, 8, 15, and 22 of Cycle 1, and then on Day 1 of Cycles 3 through 6, accounting for an additional 4 doses, i.e., a total of 8 doses of rituximab in 6 cycles.
Interventions: intervention 1: Tazemetostat intervention 2: Rituximab
Intervention descriptions: intervention 1: Study Drug intervention 2: Partner Drug

Protocol documents:
Prot_000.pdf: 
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22-Oct-2021 | 11:01 EDT
24-Oct-2021 | 10:22 EDT
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SAP_001.pdf: 
Statistical Analysis Plan 
(SL]\PH
3URWRFRO(=+ 
v1.0, 30JAN2023 
1 
STATISTICAL ANALYSIS PLAN 
Protocol EZH-1401 
SYMPHONY II: A PHASE II OPEN-LABEL, 
MULTICENTER TRIAL OF ORAL TAZEMETOSTAT IN 
COMBINATION WITH RITUXIMAB IN SUBJECTS 
WITH RELAPSED/REFRACTORY FOLLICULAR 
LYMPHOMA 
Prepared By: Ipsen, INC. 
400 Technology Square, 4th Floor 
Cambridge, Massachusetts 02139 USA 
Version 1.0 
30 January 2023 
This study is being conducted in compliance with good clinical practice, 
including the archiving of essential documents. 


Statistical Analysis Plan
(SL]\PH
3URWRFRO(=+
v1.0, 30JAN2023
2
SIGNATURE PAGE
This document has been prepared by:
Ipsen Inc.
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Statistical Analysis Plan 
v1.0, 30JAN2023 
3 
(SL]\PH
3URWRFRO(=+ 
Version History 
SAP Version 
Date 
Summary of Major Changes 
1.0 
30JAN2023 Original version 


Statistical Analysis Plan 
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v1.0, 30JAN2023 
4 
TABLE OF CONTENTS 
1.
LIST OF ABBREVIATIONS ................................................................................... 6 
2.
INTRODUCTION .................................................................................................... 7 
3.
OVERALL STUDY DESIGN .................................................................................. 8 
3.1. 
Treatment of Study Drugs ......................................................................................... 8 
3.2. 
Sample Size Considerations ...................................................................................... 8 
3.2.1. 
Sample Size Justifications ......................................................................................... 8 
3.2.2. 
Sample Size Re-estimation ....................................................................................... 9 
3.3. 
Randomization.......................................................................................................... 9 
3.4. 
Clinical Assessments ................................................................................................ 9 
4.
STUDY OBJECTIVE(S) AND ENDPOINT(S) ...................................................... 10 
4.1. 
Study Objective(s) .................................................................................................. 10 
4.2. 
Study Endpoint(s) ................................................................................................... 10 
4.3. 
Statistical Hypotheses ............................................................................................. 11 
4.4. 
Pharmacokinetic (PK) and PK/Pharmacodynamic (PD) Hypotheses ....................... 11 
5.
PLANNED ANALYSES ........................................................................................ 12 
5.1. 
Interim Analyses ..................................................................................................... 12 
5.2. 
Final Analysis ......................................................................................................... 12 
6.
ANALYSES POPULATION .................................................................................. 13 
6.1. 
Enrolled Population ................................................................................................ 13 
6.2. 
Safety Population.................................................................................................... 13 
7.
GENERAL CONSIDERATIONS FOR DATA ANALYSES AND
HANDLING ........................................................................................................... 14 
7.1. 
Baseline Definition ................................................................................................. 14 
7.2. 
Derived and Transformed Data ............................................................................... 14 
7.2.1. 
Baseline Age .......................................................................................................... 14 
7.2.2. 
Study Day ............................................................................................................... 14 
7.2.3. 
Change from Baseline ............................................................................................. 14 
7.2.4. 
Completers ............................................................................................................. 14 
8.
STATISTICAL ANALYSIS ................................................................................... 15 
8.1. 
Disposition of Subjects ........................................................................................... 15 
8.2. 
Protocol Deviations ................................................................................................ 15 
8.3. 
Demographic and Baseline Characteristics.............................................................. 15 


Statistical Analysis Plan 
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5 
8.4. 
Prior Cancer Therapy .............................................................................................. 15 
8.5. 
Prior and Concomitant Medications ........................................................................ 16 
8.6. 
Exposure and Treatment Compliance ...................................................................... 16 
9.
EFFICACY ANALYSES ....................................................................................... 17 
10.
SAFETY ANALYSES ........................................................................................... 18 
10.1. 
Adverse Events ....................................................................................................... 18 
10.2. 
Clinical Laboratory Evaluations .............................................................................. 18 
10.3. 
Other Safety Measures ............................................................................................ 18 
11.
REFERENCES ....................................................................................................... 19 
12.
APPENDIX ............................................................................................................ 20 
.............. 20 
LIST OF TABLES 
Table 1: 
List of Abbreviations ................................................................................................ 6 
CCI


Statistical Analysis Plan 
v1.0, 30JAN2023 
6 
(SL]\PH
3URWRFRO(=+ 
1.
LIST OF ABBREVIATIONS
Table 1: 
List of Abbreviations 
Abbreviation 
Term 
AE 
Adverse Event 
BMI 
Body mass index 
CRF 
Case Report Form 
CSR 
Clinical Study Report 
ECG 
Electrocardiogram 
IP 
Investigational Product 
MedDRA 
Medical Dictionary for Regulatory Activities Terminology 
SAE 
Serious Adverse Event 
TEAE 
Treatment Emergent Adverse Event 


Statistical Analysis Plan 
v1.0, 30JAN2023 
7 
(SL]\PH
3URWRFRO(=+ 
2.
INTRODUCTION
This statistical analysis plan (SAP) describes the data presentation to be used for analyzing and 
reporting efficacy and safety data for study EZH-1401. This document has been prepared based 
on EZH-1401 study protocol amendment #2 (dated 12OCT2021). This SAP is to be interpreted 
in conjunction with the protocol, and supersedes the statistical considerations described in the 
protocol.  
The study was terminated early and a synoptic clinical study report (CSR) will be prepared based 
on the final analysis after data base lock. If there were any deviations to the planned statistical 
analyses from this SAP, the justification for any such differences will be fully documented in the 
synoptic CSR.  


Statistical Analysis Plan 
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3URWRFRO(=+ 
v1.0, 30JAN2023 
8 
3.
OVERALL STUDY DESIGN
3.1. 
Treatment of Study Drugs
Tazemetostat 800 mg twice daily (BID) will be administered starting on Cycle 1 Day 1 (C1D1, 
28 days per cycle). Tazemetostat is supplied by Epizyme in pre-counted, appropriately labeled 
bottles. Tazemetostat will be administered from C1D1 to the end of Cycle 24, for a total of 
24 months of therapy. 
Rituximab will be administered by either subcutaneous injection or IV infusion according to the 
regional product prescribing information and labeling. Rituximab will be administered at a dose 
of 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1, and then on Day 1 of Cycles 3 through 6, 
accounting for an additional 4 doses, ie, a total of 8 doses of rituximab in 6 cycles. Rituximab 
will be procured by the clinical sites from commercial sources. 
3.2. 
Sample Size Considerations 
3.2.1. 
Sample Size Justifications 
The primary objective of this study is to evaluate the overall response rate obtained in subjects 
with R/R FL and wild-type (WT) EZH2 status, treated with the combination of rituximab and 
tazemetostat. Given the historical data with single agent rituximab (McLaughlin, 1998 Leonard, 
2019) we would consider the combined regimen to be of no further interest if the ORR were 50% 
or less, but of considerable interest if the ORR were at least 70%. 
Simon's two-stage design (Simon, 1989) will be used. The null hypothesis that the true response 
rate is 50% will be tested against the one-sided alternative. In the first stage, 15 subjects will be 
accrued. If there are 8 or fewer responses in these 15 subjects, the regimen will be considered as 
futile. 
Subject enrollment will continue during futility analysis. If 9 responses or greater (CR + PR) are 
seen in the initial 15 subjects, additional subjects will be accrued for a total of 54 evaluable 
subjects. The Sponsor expects 80% of enrolled subjects to have WT EZH2 status. Consequently, 
the study will enroll approximately 43 WT subjects as well as approximately 11 MT subjects. 
With an estimated early dropout rate of 10%, this study estimates a total accrual of 59 subjects. 
For the primary analysis, the null hypothesis will be rejected if 27 or more responses (CR + PR) 
are observed in the first 43 evaluable subjects regardless of mutation status. This design yields a 
one-sided type I error rate of 0.05 and power of 0.801 when the true response rate is 70%. If the 
primary analysis is successful, full analysis will be conducted once 54 evaluable subjects are 
available regardless of mutation status. Subjects in the FAS will be stratified to 2 subgroups 
depending on their EZH2 mutation status (WT vs MT). The sample size calculation is showing 
in Appendix 1. 
Assuming accrual takes place over 24 months, with at least an additional 12 months of follow-up 
for progression, there would be approximately 65% power to rule out a benchmark median PFS 
of 12 months against the alternative of a true PFS of 18 months (one-sided, 0.05 level test) in the 
primary analysis subset of 43 subjects with at least 26 PFS events. If PFS is similar in both 
subsets regardless of EZH2 status, then there would be 80% power for the same analysis in the 
combined FAS of 54 subjects with at least 33 PFS events. 


Statistical Analysis Plan 
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9 
The reporting of response rate in the MT EZH2 subset (anticipated to be 11 subjects) will have 
very little precision and is exploratory only. Note, the subjects with MT EZH2 status will be 
included in all primary safety analyses. 
3.2.2. 
Sample Size Re-estimation 
Not applicable. 
3.3. 
Randomization 
This is an open-label, one-arm study. There is no randomization in this study. 
3.4. 
Clinical Assessments 
Tumor assessments 
Tumor assessments will be performed based upon Lugano 2014 criteria at each assessment time 
point. Investigator determined response results at each assessment time point will be entered into 
the appropriate CRF. 
Biomarker Assessments 
ECOG Performance Status 
An ECOG performance status should be done at each visit as designated in the Schedule of 
Visits and Procedures (Table 2). 
Survival Follow-up Assessments 
All subjects who complete the planned 24-month tazemetostat treatment portion of the study will 
be followed for survival follow-up. Survival follow-up will be done every 6 months for 2 years, 
or until the patient has disease progression or death, whichever comes first. Survival follow up 
will be done via chart review of routine clinic appointments, patient phone calls to assess 
alive/deceased status and disease progression status. 
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4.
STUDY OBJECTIVE(S) AND ENDPOINT(S)
4.1. 
Study Objective(s)
Primary Objectives: 
x
To assess the objective response rate (ORR; complete response + partial response
[CR + PR]) of tazemetostat in combination with rituximab in subjects with
relapsed/refractory (R/R) FL and without EZH2 mutation status
Secondary Objectives: 
x
To evaluate safety of the combination of tazemetostat and rituximab by assessing
incidence of AEs, change of vital signs, lab results, and physical exam findings from
baseline
x
To estimate the median progression-free survival (PFS) of tazemetostat in
combination with rituximab at 2 years in R/R follicular lymphoma with wild type
mutation status, and in the pooled group regardless of mutation status
x
To explore response to treatment in the subset of subjects with EZH2 mutant status
x
Evaluation of efficacy outcomes in rituximab refractory subjects
4.2. 
Study Endpoint(s)
Primary Endpoint: 
x
ORR, defined as the proportion of subjects achieving PR or CR according to the 2014
Lugano Classification as assessed by Investigator and independent review committee
(IRC) at the following timepoints: Cycle 3, Cycle 6, Cycle 12, Cycle 18, and Cycle
24
Secondary Endpoints: 
x
Type, frequency, severity, timing of onset, duration, and relationship to study drug of
any treatment-emergent AEs or abnormalities of laboratory tests; serious adverse
events (SAEs); dose-limiting toxicities (DLTs), or AEs leading to discontinuation of
study treatment or death
x
PFS, assessed by a blinded IRC
x
Duration of response (DOR), defined as the time from the earliest date of CR or PR
per the 2014
x
Lugano Classification  to documented progression or death, whichever comes first, as
assessed by IRC.
x
ORR in the pooled group regardless of mutation status and in a subset of subjects
with MT EZH2 at the following time points: Cycle 3, Cycle 6, Cycle 12, Cycle 18,
and Cycle 24 for tazemetostat in combination with rituximab using 2014 Lugano
Classification.


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x
ORR in rituximab refractory subjects at the following time points: Cycle 3, Cycle 6,
Cycle 12, Cycle 18, and Cycle 24 for tazemetostat in combination with rituximab
using 2014 Lugano Classification
Exploratory Endpoints: 
x
OS, defined as the interval of time between the date of the first dose of study drug and
the date of death due to any cause.
4.3. 
Statistical Hypotheses
A one-sample Chi-square test with a 0.025 1-sided significance level to test the null hypothesis 
that overall response rate (ORR) will be YHUVXVWKHDOWHUQDWLYHK\SRWKHVLVWKDW255ZLOOEH
>70%.
4.4. 
Pharmacokinetic (PK) and PK/Pharmacodynamic (PD) Hypotheses 
Not applicable. 


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5.
PLANNED ANALYSES
5.1. 
Interim Analyses
NA 
5.2. 
Final Analysis 
The study is terminated early with 5 treated patients and the planned analyses specified in the 
protocol will not be performed. Only selected analyses will be provided to support synoptic CSR. 


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6.
ANALYSES POPULATION
6.1. 
Enrolled Population
Enrolled population will include all subjects who enrolled in the study. 
6.2. 
Safety Population 
Safety population will include all subjects who received at least 1 dose of study drug and have at 
least 1 post-baseline safety evaluation, regardless of mutation status. This will the analysis set for 
all evaluation in the final analysis. 


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7.
GENERAL CONSIDERATIONS FOR DATA ANALYSES AND
HANDLING
7.1. 
Baseline Definition
Baseline is defined as the last non-missing (including unscheduled) assessment value prior to the 
initial administration of the study drug. If an assessment is performed on the same day as the first 
dose of study drug, and time is not collected, the assessment will be considered baseline. If there 
is more than one value on or prior to the initial administration of the study drug, the value closest 
to and prior to the receipt of the first dose, whether scheduled or unscheduled, will be used as the 
baseline value.   
AEs and medications reported with a start date on the date of first dose will be considered to 
have occurred after the start of treatment. For vital signs (excluding weight and height) and ECG 
measures, baseline results will be identified for the set. Baseline will be determined separately 
for each laboratory analyte. 
7.2. 
Derived and Transformed Data 
7.2.1. 
Baseline Age 
Subject’s age in years will be calculated based on date of informed consent date using the 
following formula: 
Age (year) = FLOOR ((date of informed consent – date of birth)/365.25*12) 
where FLOOR( ) function returns the integer part of the result. 
7.2.2. 
Study Day 
If the date of interest occurs on or after the first dose then study day will be calculated as (date of 
interest – date of first dose) + 1. If the date of interest occurs prior to the first dose date then 
study day will be calculated as (date of interest – date of first dose). There is no study day 0. 
7.2.3. 
Change from Baseline 
NA 
7.2.4. 
Completers 
All subjects discontinued the study. 


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8.
STATISTICAL ANALYSIS
This study was early terminated. Given there were only 5 subjects enrolled, only selected safety 
analyses will be done based on safety population. No futility analysis or efficacy analysis will be 
performed. 
All summary tables will have column ‘Total’ only. 
8.1. 
Disposition of Subjects 
The number of subjects enrolled will be summarized based on the following categories: 
x
Enrolled population
x
Safety population
x
Study drug ongoing/completed/discontinued (including reason)
x
Study ongoing/completed/discontinued (including reason)
A subject listing of disposition information will also be presented for the safety population. 
8.2. 
Protocol Deviations 
No protocol deviation information collected at the time of study termination. 
8.3. 
Demographic and Baseline Characteristics 
The following variables will be summarized to describe the demographics and other baseline 
disease characteristics at enrollment: 
x
Age summarized as a continuous variable in years relative to the date informed
consent is signed.  Age will also be summarized categorically based on the following
age groups:>=65 years and     < 65 years
x
Sex (male, female)
x
race (American Indian or Alaska Native, Asian, Black of African American, Native
Hawaiian or Other Pacific Islander, White, Other/Unknown)
x
ethnicity (Hispanic or Latino, not Hispanic or Latino, Not Reported)
x
Tumor type (Follicular Lymphoma, Other) and Grade
x
Number of prior lines of anticancer therapy as a continuous variable and also
summarized categorically based on the categories: <=2, 3, 4, >=5
x
Best response to prior anticancer therapy (Complete response, Partial response,
Progressive disease, Not evaluable, Unknown)
8.4. 
Prior Cancer Therapy
Prior Cancer therapy will be summarized for the following variables: 
x
Number of prior lines of anticancer therapy will be summarized as a continuous
variable and also categorically based on the categories: <=2, 3, 4, >=5


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x
Best response to prior anticancer therapy (Complete response, Partial response,
Progressive disease, Not evaluable, Unknown)
A by-subject listing will be also provided. 
8.5. 
Prior and Concomitant Medications 
A by-subject listing will be provided for prior and concomitant medications 
8.6. 
Exposure and Treatment Compliance 
The following variables will be summarized for exposure and treatment compliance of 
Tazemetostat and Rituximab: 
x
Duration of tazemetostat/rituximab summarized as continuous variable and as
categorical variables
x
Number of cycles initiated for tazemetostat/rituximab
x
Total amount of tazemetostat/rituximab taken (mg)
x
Average dose intensity of tazemetostat/rituximab (mg BID/day)
x
Percentage of tazemetostat/rituximab taken
x
Category of percentage of drug taken


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EFFICACY ANALYSES
No efficacy analysis will be performed. 


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SAFETY ANALYSES
All the safety measurements will be listed in the listings for safety population. 
10.1. 
Adverse Events 
The following AE listings will be provided: 
x
All adverse events
x
All serious adverse events (SAEs)
x
Treatment emergent adverse events (TEAEs)
x
Treatment emergent SAEs
x
TEAEs leading to discontinuation of study drug
10.2. 
Clinical Laboratory Evaluations 
The following listings will be provided for clinical laboratory evaluations: 
x
Laboratory Data – Hematology
x
Laboratory Data – Blood chemistry and coagulation
x
Laboratory Data – Urinalysis
x
Grades 3 and 4 Laboratory Data - Hematology
x
Grades 3 and 4 Laboratory Data - Blood Chemistry and Coagulation
x
Laboratory Results < 0.25 x LLN or > 2.5 x ULN – Hematology
x
Laboratory Results < 0.25 x LLN or > 2.5 x ULN - Blood Chemistry and Coagulation
10.3. 
Other Safety Measures 
The following listings will be provided for ECG and Vital sign: 
x
12-lead Electrocardiogram
x
Vital Signs


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11.
REFERENCES
McLaughlin P, Grillo-Lopez AJ, Link BK, et al. Rituximab chimeric anti-CD20 monoclonal 
antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose 
treatment program. J Clin Oncol. 1998;16(8):2825-2833. 


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APPENDIX
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