BeOne reports positive sonrotoclax phase 1/2 results for mantle cell lymphoma

BeOne Medicines Ltd. reported positive topline results from its Phase 1/2 study of sonrotoclax, an investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). The global, multicenter, single-arm, open-label study enrolled 125 patients who had previously received anti-CD20 therapy and a Bruton’s tyrosine kinase inhibitor (BTKi). The study met its primary endpoint, demonstrating that sonrotoclax elicited clinically meaningful overall response rates (ORR), as assessed by an independent review committee.

The study also showed promising results across several secondary efficacy endpoints, including complete response (CR) rate, duration of response (DOR), and progression-free survival (PFS). Sonrotoclax’s safety profile was generally well-tolerated with manageable toxicities. BeOne plans to submit these data to the U.S. Food and Drug Administration (FDA) and other global regulatory bodies for potential approval of sonrotoclax in R/R MCL. The U.S. FDA previously granted sonrotoclax Orphan Drug Designation for MCL treatment.

The company will present the full data at an upcoming medical meeting. This milestone reinforces BeOne’s hematology franchise, which now includes three foundational medicines for B-cell malignancies.