BeOne Medicines said its investigational BCL-2 inhibitor sonrotoclax achieved the main goal in a global Phase 1/2 study of 125 adults with relapsed or refractory mantle cell lymphoma who had previously received a Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy. The single-arm trial met its primary endpoint, delivering a clinically meaningful overall response rate as judged by an independent review committee. The company reported encouraging results across secondary measures, including complete response rate, duration of response and progression-free survival, while noting that the oral treatment was generally well tolerated with manageable toxicities. Sonrotoclax already holds U.S. orphan-drug and Fast Track designations for mantle cell lymphoma. BeOne plans to file the data with the Food and Drug Administration and other regulators to seek approval of what could become the first BCL-2 inhibitor for this hard-to-treat blood cancer. A Phase 3 confirmatory study, CELESTIAL-RR MCL, has begun enrolling patients.