Regulatory2026-06-30

BRUKINSA (zanubrutinib) plus rituximab - (MANGROVE)

BeOne Medicines Ltd.ONC
Indication
Previously untreated mantle cell lymphoma (MCL)
Stage
phase3
Event
Submission
Details

June 30, 2026: BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235) announced positive topline results from the Phase 3 MANGROVE trial (BGB-3111-306; NCT04002297) in previously untreated mantle cell lymphoma (MCL), comparing BRUKINSA (zanubrutinib) plus rituximab vs bendamustine plus rituximab (BR). In a prespecified interim analysis, the study met its primary endpoint of progression-free survival (PFS) by independent review committee, with BRUKINSA+rituximab reducing the risk of progression or death by 43% vs BR (HR 0.57; 95% CI 0.43–0.76; p<0.0001). Safety was consistent with known profiles and no new safety signals were reported. Overall survival was immature, though a trend favoring BRUKINSA+rituximab was observed; OS will be formally tested at the final analysis. The company said full efficacy and safety results will be presented at an upcoming medical meeting and that global regulatory submissions are planned for 2H 2026.