BeOne Medicines has reported positive topline Phase 3 results showing that BRUKINSA (zanubrutinib) plus rituximab reduced the risk of disease progression or death in previously untreated mantle cell lymphoma (MCL) compared with bendamustine plus rituximab. In the global, randomized MANGROVE study, the BTK inhibitor–based regimen cut the risk of progression or death by 43% versus the chemoimmunotherapy standard (hazard ratio 0.57; 95% confidence interval 0.43–0.76; p<0.0001), meeting the primary endpoint of progression-free survival.
The trial is described as the first Phase 3 study to test a chemotherapy‑free regimen against standard chemoimmunotherapy in frontline MCL, and also the first to use a chemotherapy‑free, rituximab maintenance‑free approach in this setting. According to BeOne Medicines, the BRUKINSA plus rituximab regimen could spare patients roughly two years of infusion‑based treatment. The safety profile of the combination was consistent with that of each medicine individually, and no new safety signals were observed. Overall survival, a key secondary endpoint, was immature at the time of the interim analysis, but the company reported a strong trend favoring the BRUKINSA regimen, with formal testing planned at final analysis.
Mantle cell lymphoma is a rare, typically aggressive B‑cell non‑Hodgkin lymphoma that mainly affects older adults, whose comorbidities can complicate treatment tolerability. Frontline care has traditionally relied on chemoimmunotherapy such as bendamustine plus rituximab, which carries risks including myelosuppression, prolonged immune suppression, infection risk and cumulative toxicity. BeOne Medicines said MANGROVE differs from previous efforts that added BTK inhibitors to chemotherapy, by instead evaluating a chemotherapy‑free BRUKINSA plus rituximab approach aimed at durable disease control without upfront chemotherapy. Full efficacy and safety results will be presented at an upcoming medical meeting, and global regulatory submissions are planned for the second half of 2026.
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