[Translation] A Phase IB/III, double-blind, randomized, active-controlled, 3-stage, biomarker-adaptive study evaluating TAZEMETOSTAT or placebo in combination with lenalidomide + rituximab in subjects with relapsed/refractory follicular lymphoma
主要目的:分别在具有EZH2 WT和EZH2 MT的R/R FL患者中评价和比较研究者评估的tazemetostat+R2与安慰剂+R2的无进展生存期(PFS)。 次要目的:分别在具有EZH2 WT和EZH2 MT的R/R FL患者人群,以及所有R/R FL患者(不考虑突变状态)中评价和比较完全缓解率(CRR)、客观缓解率(ORR)、总生存期(OS)、缓解持续时间(DOR)、完全缓解持续时间(DOCR)、疾病控制率(DCR)、安全性和耐受性;在R/R FL人群(不考虑突变状态)中评价和比较由研究者评估的PFS,分别在具有EZH2 WT和EZH2 MT的R/R FL患者人群,以及所有R/R FL患者(不考虑突变状态)中评价和比较由盲态独立审查委员会(IRC)评估的PFS;分别在具有EZH2 WT和EZH2 MT的R/R FL患者人群以及所有R/R FL患者中(不考虑突变状态)评估群体PK参数(包括tazemetostat与R2联合用药时的暴露量-效应关系)和通过EQ-5D-5L工具和FACT-Lym测量的健康相关生活质量(QoL)。
[Translation] Primary objective: To evaluate and compare investigator-assessed progression-free survival (PFS) of tazemetostat+R2 versus placebo+R2 in R/R FL patients with EZH2 WT and EZH2 MT, respectively. Secondary objectives: To evaluate and compare complete response rate (CRR), objective response rate (ORR), overall survival (OS), duration of response (DOR), duration of complete response (DOCR), disease control rate (DCR), safety, and tolerability in the R/R FL patient population with EZH2 WT and EZH2 MT, and in all R/R FL patients (regardless of mutation status); to evaluate and compare PFS assessed by investigator in the R/R FL population (regardless of mutation status), and PFS assessed by blinded independent review committee (IRC) in the R/R FL patient population with EZH2 WT and EZH2 MT, and in all R/R FL patients (regardless of mutation status); to evaluate and compare PFS assessed by investigator in the R/R FL patient population with EZH2 WT and EZH2 MT, and in all R/R Population PK parameters, including the exposure-response relationship of tazemetostat when co-administered with R2, and health-related quality of life (QoL) measured by the EQ-5D-5L tool and FACT-Lym were assessed in FL patients regardless of mutation status.