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登上Cell子刊:正大天晴BET抑制剂临床试验结果发布,安全有效治疗复发或难治性淋巴瘤
生物世界· 2025-10-29 04:21
Core Viewpoint - The article discusses the clinical trial results of TQB3617, a BET inhibitor developed by Zhengda Tianqing, showing acceptable safety and good efficacy in patients with relapsed or refractory lymphoma [2][8]. Summary by Sections Clinical Trial Overview - The phase 1 clinical trial evaluated the safety, pharmacokinetics, and efficacy of TQB3617 in patients with relapsed or refractory lymphoma, with primary endpoints including safety, dose-limiting toxicity (DLT), and recommended phase 2 dose (RP2D) [3]. - A total of 39 patients were enrolled, receiving oral TQB3617 at doses ranging from 0.05 to 0.25 mg daily [3]. Safety and Adverse Events - The most common treatment-related adverse event was thrombocytopenia, occurring in 36% of patients (14 out of 39) [3][5]. - The safety monitoring committee recommended a dose of 0.1 mg daily for phase 2 trials after observing adverse events at higher doses [3]. Efficacy Results - The objective response rate (ORR) was 31% (12 out of 39), with 4 patients achieving complete remission [4][5]. - The ORR for Hodgkin lymphoma patients was 31% (5 out of 16), T-cell lymphoma patients also had an ORR of 31% (5 out of 16), and B-cell lymphoma patients had an ORR of 29% (2 out of 7) [4]. Key Highlights - TQB3617's recommended phase 2 dose was confirmed, demonstrating acceptable safety with thrombocytopenia as the main toxic effect [5]. - The drug exhibited good anti-tumor efficacy with an overall response rate of 31% [5].