Core Insights - BeOne Medicines Ltd. announced new data on sonrotoclax, a next-generation BCL2 inhibitor, showing significant clinical benefits as both a monotherapy and in combination therapies for B-cell malignancies, particularly at the 67th American Society of Hematology Annual Meeting [1][2] Summary by Category Clinical Data - Sonrotoclax demonstrated an overall response rate (ORR) of 52.4% in patients with relapsed/refractory mantle cell lymphoma (MCL), with a complete response (CR) rate of 15.5% in a Phase 1/2 study [3] - The median duration of response (DOR) was 15.8 months, with a median time to response (TTR) of 1.9 months and a median progression-free survival (PFS) of 6.5 months [4] - In combination therapies, sonrotoclax plus zanubrutinib achieved a 100% ORR in 135 efficacy-evaluable patients, with a CR/CRi rate of 55% [7] Safety and Tolerability - Treatment with sonrotoclax monotherapy was generally well tolerated, with manageable adverse events; the most common grade 3 treatment-emergent adverse events included neutropenia (19.1%), infections (16.5%), and pneumonia (10.4%) [5] - The combination therapies also showed good tolerability, with no treatment-emergent adverse events leading to death or significant complications [13][14] Regulatory Status - Sonrotoclax is under Priority Review by the U.S. Food and Drug Administration (FDA) for potential accelerated approval, having received Breakthrough Therapy Designation and Fast Track Designation for MCL and other conditions [5][17] Market Potential - Sonrotoclax could become the first BCL2 inhibitor approved for relapsed/refractory MCL in the U.S., with the potential to transform treatment outcomes for patients with limited options [3][6]