BeOne Medicines announces positive topline results for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy.

BeOne Medicines announced positive topline results from a Phase 1/2 study (BGB-11417-201) of sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, in adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. 

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy and safety of sonrotoclax.

The study met its primary endpoint of overall response rate (ORR) as assessed by an independent review committee (IRC), 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 (CR) rate, duration of response (DOR) and progression-free survival (PFS). 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. Food and Drug Administration (FDA) and other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL.

New drug applications for sonrotoclax for the treatment of R/R MCL and R/R CLL/SLL have also been accepted and are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval. The Phase 3 confirmatory CELESTIAL-RR MCL study (BGB-11417-302; NCT06742996) is underway, with the first patient enrolled earlier this year. The U.S. FDA previously granted sonrotoclax Orphan Drug Designation for the treatment of patients with MCL.