Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study.

作者：Weili Zhao, Jun Zhu, Yuqin Song, Pengpeng Xu, Jianzhen Shen, Qingqing Cai, Hui Zhou, Liling Zhang, Ying Xiang, Xiuhua Sun, Wei Yang, Zhihua Yao, Hongmei Jing, Shujuan Wen, Jie Jin, Hong‐Wei Xue, Hong Cen, Kaiyang Ding, Zhengming Jin, Xiaojing Xing · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.17_suppl.lba7003 · 被引用次数：17 · 研究领域：Histone Deacetylase Inhibitors Research、Protein Degradation and Inhibitors、CAR-T cell therapy research

LBA7003 Background: Epigenetic dysregulation is commonly correlated with the pathogenesis and development in diffuse large B-cell lymphoma (DLBCL). Tucidinostat, a subtype-selective histone deacetylase (HDAC) inhibitor, has shown promising efficacy in combination with R-CHOP in DLBCL patients with double expression of MYC and BCL2 (DE) in exploratory studies. Methods: We conducted a randomized, double-blind, placebo-controlled, phase III trial (DEB) to evaluate the efficacy and safety of tucidinostat plus R-CHOP in comparison with R-CHOP in previously untreated DLBCL patients with DE. Patients were randomly assigned in a 1:1 ratio to receive six cycles of either tucidinostat plus R-CHOP (tucidinostat group) or placebo plus R-CHOP (placebo group). Patients who achieved complete response (CR) after combination therapy received either tucidinostat or placebo as maintenance treatment with a maximum duration of 24 weeks. The primary endpoint was investigator-assessed event-free survival (EFS), and the key secondary endpoint was the complete response rate (CRR) evaluated at the end of combination treatment. An interim analysis was pre-defined to be conducted when CRR was obtained and the number of EFS events reached at least 60% of the total events required for entire study. Results: Between May 21, 2020, and July 25, 2022, 423 patients were enrolled and randomly assigned, 211 to the tucidinostat group and 212 to the placebo group. At data cutoff of this interim analysis (January 1...