BeOne Medicines reports ‘positive’ results from Phase 1/2 study of sonrotoclax

BeOne Medicines (ONC) announced positive topline results from a Phase 1/2 study of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory mantle cell lymphoma, following treatment with a Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy. BeOne plans to present the full data at an upcoming medical meeting. The study met its primary endpoint of overall response rate as assessed by an independent review committee, demonstrating that treatment with sonrotoclax elicited clinically meaningful responses in this heavily pretreated population. The study also showed promising results across several secondary efficacy endpoints, including complete response rate, duration of response and progression-free survival. The safety profile was generally well-tolerated, and the toxicities were manageable. These findings represent another important milestone in BeOne’s hematology franchise, which now includes three foundational medicines designed to address the ongoing and evolving needs of patients across B-cell malignancies. BeOne plans to submit these data to the U.S. FDA and other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL.