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 enrolled 510 patients across 176 sites worldwide
- ▪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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