BeOne Medicines highlights positive Phase 3 findings for BRUKINSA in frontline mantle cell lymphoma

BeOne Medicines has announced positive topline findings from the Phase 3 MANGROVE study, which evaluated BRUKINSA, a foundational BTK inhibitor, combined with rituximab against bendamustine plus rituximab in adults with previously untreated mantle cell lymphoma. MANGROVE marks the first Phase 3 global randomised trial to pit a BTK inhibitor-based, chemotherapy-free regimen against standard chemoimmunotherapy in this treatment setting, building on an already well-established body of clinical evidence for BRUKINSA in mantle cell lymphoma.

“For patients with newly diagnosed MCL, chemotherapy is currently the default. MANGROVE demonstrates for the first time that BRUKINSA plus rituximab, a chemotherapy-free regimen, can deliver unprecedented improvements in progression-free survival, potentially redefining the treatment paradigm globally. We believe it would be very meaningful for patients to be free from the burden of frequent infusions. This is what it means to state that BRUKINSA is foundational: another study where it anchors frontline therapy and extends its leadership across B-cell malignancies,” said Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines.

At a prespecified interim analysis, MANGROVE cleared its primary endpoint of progression-free survival, with BRUKINSA plus rituximab demonstrating a highly statistically significant and clinically meaningful advantage over bendamustine plus rituximab as assessed by an independent review committee. The trial is the first of its kind in first-line mantle cell lymphoma to adopt a chemotherapy-free approach without rituximab maintenance, sparing patients roughly two years of infusion visits. The BRUKINSA-based combination reduced the likelihood of progression or death by 43%. Safety findings for the combination were in keeping with the established profiles of both medicines, and no new safety signals emerged. Overall survival, tracked as a key secondary endpoint, had not yet matured at the point of this analysis, though early trends favoured the BRUKINSA combination, with a formal overall survival assessment planned as part of the final analysis.

Full data from MANGROVE will be presented at a future medical meeting, and the company is actively engaging with regulatory authorities globally in preparation for submissions in the second half of 2026.

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Related Topics and Keywords

beone, beone medicines, brukinsa, mantle cell lymphoma, Phase 3 trial