BeOne Medicines announces positive topline results from its Phase 3 MANGROVE trial, demonstrating that a chemotherapy-free regimen of BRUKINSA plus rituximab reduces the risk of disease progression or death by 43% compared to standard chemoimmunotherapy in patients with previously untreated mantle cell lymphoma. The trial of 510 patients met its primary endpoint of progression-free survival, offering a potential new standard of care. BeOne plans global regulatory submissions in the second half of 2026.
MANGROVE Phase 3 trial results
▪The safety profile of BRUKINSA plus rituximab in the Phase 3 MANGROVE trial was consistent with the known safety profiles of both medicines, with no new safety signals identified.
▪The Phase 3 MANGROVE clinical trial met its primary endpoint of progression-free survival, evaluating BRUKINSA plus rituximab against bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma.
Chemotherapy-free MCL treatment paradigm
▪The Phase 3 MANGROVE trial is the first global, randomized trial to evaluate a Bruton tyrosine kinase inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in previously untreated mantle cell lymphoma.
▪The chemotherapy-free regimen of BRUKINSA plus rituximab evaluated in the MANGROVE trial utilizes a rituximab maintenance-free approach, sparing patients approximately two years of infusions.
BRUKINSA plus rituximab efficacy
▪In the Phase 3 MANGROVE trial, BRUKINSA plus rituximab reduced the risk of disease progression or death by 43% compared to bendamustine plus rituximab.
▪The Phase 3 MANGROVE trial showed a strong trend in overall survival in favor of BRUKINSA plus rituximab, though overall survival data was immature at the time of the interim analysis.
Mantle cell lymphoma treatment burden
▪Mantle cell lymphoma is a rare, aggressive type of B-cell non-Hodgkin lymphoma that predominantly affects older adults who often have comorbidities.
▪Standard frontline chemoimmunotherapy for mantle cell lymphoma carries clinical burdens including myelosuppression, prolonged immune suppression, heightened infection risk, and cumulative toxicity.
BRUKINSA global regulatory submissions
▪BeOne Medicines plans to submit global regulatory filings for BRUKINSA plus rituximab in frontline mantle cell lymphoma in the second half of 2026.
▪BeOne Medicines plans to present the full efficacy and safety results from the Phase 3 MANGROVE trial at an upcoming medical meeting.
BTK inhibitor approval status
▪BRUKINSA is approved in more than 80 markets globally and has been used to treat over 290,000 patients worldwide.
▪The global clinical development program for BRUKINSA spans more than 8,000 patients across over 45 trials in more than 30 countries and regions.
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