Sonrotoclax

BeOne Medicines said its candidate for a rare but aggressive form of B cell lymphoma has passed an early-stage test. Its BCL2 inhibitor, known as sonrotoclax, met the primary endpoint of overall response rate in a single-arm Phase 1/2 study of 125 patients with relapsed or refractory mantle cell lymphoma (MCL). The participants received sonrotoclax following treatment with anti-CD20 therapy and a BTK inhibitor, according to a Friday release . Sonrotoclax also demonstrated “promising results” in secondary endpoints, including complete response rate, duration of response, and progression-free survival, but BeOne did not provide data. It plans to present more results at a future medical meeting and share them with agencies, including the FDA. BeOne is planning to file the drug for accelerated approval. Sonrotoclax is already being evaluated in a confirmatory Phase 3 trial called CELESTIAL-RR MCL, which enrolled its first patient earlier this year. The placebo-controlled study is testing the drug in combination with BeOne’s BTK inhibitor Brukinsa in patients who have previously received anti-CD20 treatment or chemoimmunotherapy, according to the clinical trials register. BeOne, formerly BeiGene, successfully carved a market niche in the B cell non-Hodgkin lymphoma space with Brukinsa. The drug won its first FDA approval in 2019 for MCL, later securing label expansions for certain settings of marginal zone lymphoma, chronic lymphocytic leukemia and follicular lymphoma. While Brukinsa targets the BTK enzyme, which is crucial for the growth of B cells, sonrotoclax targets a protein called B cell lymphoma 2, known to help cancer cells survive. Sonrotoclax works by mimicking natural cell death signals, according to BeOne. The drugmaker estimates that MCL affects around 28,000 people globally. The treatment landscape for relapsed or refractory disease is “fragmented,” and outcomes are “unacceptably poor,” BeOne’s head of R&D Lai Wang said in the release.

BeOne Medicines said it will seek regulatory approvals in the US and elsewhere globally for sonrotoclax (BGB-11417), following the release of positive topline data from a Phase I/II trial in relapsed or refractory mantle cell lymphoma (MCL). The 125-patient study met its primary endpoint of overall response rate, positioning the next-generation BCL2 inhibitor for potential approval in the rare and aggressive form of blood cancer.The trial enrolled adult patients whose disease had progressed following treatment with anti-CD20 therapy and a BTK inhibitor. Results showed "clinically meaningful responses in this heavily pretreated population" and "promising results" across secondary endpoints including complete response rate, duration of response and progression-free survival, according to the company. Additionally, the safety profile was generally well-tolerated and "toxicities were manageable." Full data will be shared at an upcoming medical meeting."For people with relapsed or refractory mantle cell lymphoma, the disease is aggressive, the treatment landscape fragmented, and the outcomes unacceptably poor," remarked Lai Wang, BeOne's global head of R&D. Wang said the topline results "underscore [sonrotoclax's] potential to deliver meaningful and durable responses" for patients with relapsed/refractory MCL, which affects an estimated 28,000 people globally and has a five-year survival rate of approximately 50%.BeOne is already familiar with the MCL space through Brukinsa (zanubrutinib), its BTK inhibitor approved by the FDA for multiple B-cell malignancies, including second-line MCL in 2019. The drug, which generated sales of roughly $2.4 billion across the US and Europe in 2024, is also cleared for Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) and follicular lymphoma.BeOne said new drug applications for sonrotoclax are already under review in China for both relapsed/refractory MCL and CLL/SLL. The company also launched earlier this year the Phase III confirmatory CELESTIAL-RR MCL study, which will evaluate sonrotoclax in combination with Brukinsa versus Brukinsa alone in an estimated 300 patients with relapsed/refractory mantle cell lymphoma.