Zhi Tong Cai Jing·2025-08-29 11:17Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its investigational BCL2 inhibitor, Sotorasib, for treating adult patients with mantle cell lymphoma (MCL) who have previously received BTK inhibitors and anti-CD20 therapies [1][2] - The trial demonstrated significant and durable responses, indicating the potential of Sotorasib to provide the first BCL2 inhibitor treatment option for MCL patients if approved [1][2] Group 1: Clinical Trial Details - The BGB-11417-201 study is a global, multicenter, single-arm, open-label Phase 1/2 trial that enrolled 125 adult MCL patients previously treated with BTK inhibitors and anti-CD20 therapies [1] - In the first part of the study, 22 patients received daily doses of either 160 mg or 320 mg of Sotorasib to assess safety and tolerability, leading to the determination of the recommended dose for the second part [1] - The second part involved 103 patients receiving the recommended daily dose of 320 mg to evaluate the efficacy and safety of Sotorasib [1] Group 2: Efficacy and Safety Results - The study achieved the primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), indicating clinically meaningful responses in the patient population [2] - Secondary efficacy endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS), also showed positive results [2] - The safety profile of Sotorasib was generally well-tolerated, with manageable toxicity, marking an important milestone in BeiGene's product portfolio for hematologic malignancies [2] Group 3: Regulatory and Market Implications - BeiGene is submitting data to the FDA and global regulatory agencies to seek potential approval for Sotorasib in the MCL indication [2] - The new drug application for Sotorasib for treating MCL and CLL/SLL patients has been accepted by the National Medical Products Administration (NMPA) in China and is under priority review [2] - A confirmatory Phase 3 study, CELESTIAL-RRMCL (BGB-11417-302), is ongoing, with the first patient enrolled earlier this year [2]