BeOne Medicines reports positive phase 3 data for Brukinsa plus rituximab in MCL
- BeOne Medicines (NASDAQ:ONC) announced positive topline results from the Phase 3 MANGROVE study of BRUKINSA plus rituximab versus bendamustine plus rituximab in previously untreated mantle cell lymphoma.
- The chemotherapy-free regimen demonstrated a 43% reduction in the risk of progression or death, meeting the primary endpoint.
- BeOne Medicines plans regulatory submissions in the second half of 2026 based on the MANGROVE data.
BeOne Medicines (NASDAQ:ONC) announced positive topline results from the Phase 3 MANGROVE study evaluating BRUKINSA plus rituximab versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma.
MANGROVE is the first Phase 3 global randomized trial to evaluate a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in this setting.
The study met its primary endpoint of progression-free survival, demonstrating a highly statistically significant and clinically meaningful improvement for BRUKINSA plus rituximab versus BR, as assessed by an independent review committee.
BRUKINSA plus rituximab led to a 43% reduction in the risk of progression or death (HR=0.57; p<0.0001).
The safety profile was consistent with the known profiles of both medicines, with no new safety signals identified.
Overall survival, a key secondary endpoint, showed a strong trend in favor of the BRUKINSA combination, though it remains immature.
BeOne Medicines is in discussions with global regulatory authorities with planned submissions in the second half of 2026.
The company believes the results have practice-changing potential for patients with mantle cell lymphoma, offering a chemotherapy-free option that could reduce treatment burden while improving outcomes.
