ONC News & Events

BeOne Medicines announced positive topline results from the Phase 3 MANGROVE study evaluating foundational BTK inhibitor Brukinsa - zanubrutinib - plus rituximab versus bendamustine plus rituximab, or BR, in adult patients with previously untreated mantle cell lymphoma, or MCL. MANGROVE is the first Phase 3, global, randomized trial to evaluate a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in this setting. This pivotal Phase 3 trial builds on the established clinical evidence for Brukinsa in MCL. MANGROVE met its primary endpoint of progression-free survival, demonstrating a highly statistically significant and clinically meaningful improvement for Brukinsa plus rituximab versus BR. This Brukinsa -based, chemotherapy-free regimen led to a 43% reduction in the risk of progression or death. The safety profile of Brukinsa plus rituximab was consistent with the known safety profile of both medicines, with no new safety signals identified. Overall survival, a key secondary endpoint, was immature at the time of this analysis; however, a strong trend in favor of Brukinsa plus rituximab was observed. OS will be tested as part of the final analysis. The company is in discussions with global regulatory authorities with planned submissions in 2H26.

BeOne Medicines announced the presentation of a large Phase 3 dataset in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, CLL/SLL, aged 80 and older, showing sustained benefit with Brukinsa after nearly 6.5 years of follow-up, reinforcing its role as the foundational BTK inhibitor. Brukinsa is the only BTK inhibitor to demonstrate superior efficacy vs. ibrutinib in a Phase 3 trial. These data, one of the largest datasets of older patients with treatment-naive CLL, will be presented at the 2026 European Hematology Association, EHA, Congress in Stockholm, Sweden. Key highlights: Sequoia subgroup analysis showed that age did not limit benefit in patients with CLL treated with Brukinsa; 78-month Sequoia data reinforce Brukinsa as the "foundational BTK inhibitor" in CLL; Real-world efficacy and safety data consistently underscore "foundational Brukinsa as the best-in-class BTKi" for TN CLL