Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study

作者：Junning Cao, Guangliang Chen, Lihua Qiu, Liling Zhang, Ming Jiang, Ying Cheng, Qiaohua Zhang, Lihong Liu, Pu Li, Yue-Rong Shuang, Huaqing Wang, Hong‐Wei Xue, Huijing Wu, Meifang Zheng, Keshu Zhou, Zhiming Li, Hongmei Jing, Wei Yang, Zunmin Zhu, Wenyu Li, Jiaxuan Wangwu, Heyu Huang, Qiantao Jia, Dongmei Chen, Songhua Fan, Meiqi Shi, Weiguo Su · 发表于：EClinicalMedicine · 年份：2025 · DOI：10.1016/j.eclinm.2025.103399 · 被引用次数：5 · 研究领域：Lymphoma Diagnosis and Treatment、Chronic Lymphocytic Leukemia Research、Ovarian cancer diagnosis and treatment

Background Tazemetostat, the first enhancer of zeste homolog 2 (EZH2) inhibitor approved by the U.S. Food and Drug Administration, has shown efficacy in a global population with relapsed or refractory (R/R) follicular lymphoma (FL). This phase 2 study was primarily designed as a registration-intent bridging trial of tazemetostat in Chinese patients with EZH2- mutant ( EZH2 mut ) R/R FL; the study also included evaluation in the EZH2 wild-type ( EZH2 wt ) population. Methods This multicentre, single-arm, phase 2 study was conducted at 19 sites in China. Eligible patients (aged ≥18 years) with histologically confirmed grade 1–3a FL were categorised by EZH2 status: mutant ( EZH2 mut , bridging cohort) and wild-type ( EZH2 wt ), and received oral tazemetostat 800 mg twice daily in continuous 28-day cycles until investigator-assessed disease progression, intolerable toxicity, withdrawal of consent, or other protocol-specified criteria. The EZH2 mut cohort primary endpoint was independent review committee (IRC)-assessed objective response rate (ORR). Efficacy in the EZH2 mut cohort was assessed in patients who received at least one dose of tazemetostat and had centrally confirmed FL. Efficacy in the EZH2 wt cohort and safety in both cohorts were assessed in all patients who received at least one dose of tazemetostat. This study is registered with ClinicalTrials.gov, NCT05467943. Findings Between July 29, 2022, and Aug 31, 2023, 22 patients with EZH2 mut R/R FL were enrolled (three ...