Ge Long Hui·2025-08-29 11:25Core Insights - BeiGene announced positive results from the Phase 1/2 clinical trial of its next-generation 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] Company Developments - The clinical study (BGB-11417-201) enrolled 125 adult patients with MCL, assessing safety, tolerability, and efficacy of Sotorasib at doses of 160 mg and 320 mg [1] - The study achieved the primary endpoint of overall response rate (ORR) and showed positive results in secondary endpoints, including complete response rate (CRR), duration of response (DOR), and progression-free survival (PFS) [2] - BeiGene is submitting data to the FDA and other global regulatory agencies for potential approval of Sotorasib in MCL, with the drug already accepted for priority review by China's NMPA [2] Industry Context - The study's results mark a significant milestone in BeiGene's product portfolio for hematologic malignancies, which currently includes three major products aimed at addressing the evolving clinical needs of B-cell malignancy patients [2] - The ongoing Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302) has already enrolled its first patient earlier this year, further supporting the development of Sotorasib [2]