BeOne Medicines Announces Positive Sonrotoclax Results for R/R Mantle Cell Lymphoma

BeOne Medicines has announced positive topline results for its investigational BCL2 inhibitor, sonrotoclax, in a Phase 1/2 study for relapsed or refractory mantle cell lymphoma. The study met its primary endpoint of overall response rate, demonstrating clinically meaningful responses in a heavily pretreated population. The safety profile was generally well-tolerated, and the toxicities were manageable. BeOne plans to present the full data at an upcoming medical meeting and submit the results to the FDA and other global regulatory bodies for potential approval.

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235) has 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). The study met its primary endpoint of overall response rate (ORR), demonstrating clinically meaningful responses in a heavily pretreated population. The safety profile was generally well-tolerated, and the toxicities were manageable. BeOne plans to present the full data at an upcoming medical meeting and submit the results to the FDA and other global regulatory bodies for potential approval.

The BGB-11417-201 study enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a Bruton’s tyrosine kinase inhibitor (BTKi). 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 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.

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.

Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL) that affects an estimated 28,000 people globally. The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.

Sonrotoclax is a next-generation and potential best-in-class investigational inhibitor of B-cell lymphoma 2 (BCL2), which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a highly potent and specific inhibitor of BCL2 with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and nearly 2,000 patients have been enrolled to date across the broad global development program. The U.S. Food and Drug Administration (FDA) granted sonrotoclax Fast Track Designation for the treatment of adult patients with mantle cell lymphoma (MCL) and Waldenström macroglobulinemia (WM).

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

References:
[1] https://www.marketscreener.com/news/beone-medicines-announces-positive-topline-results-for-sonrotoclax-in-relapsed-or-refractory-mantle-ce7c50dcd081f225
[2] https://www.stocktitan.net/news/ONC/be-one-medicines-announces-positive-topline-results-for-sonrotoclax-o8pjsg53ttty.html