BeiGene Announces Positive Phase 3 MANGROVE Trial Results for Zanubrutinib in First-Line Mantle Cell Lymphoma

On June 30, BeOne announced itsCornerstone ProductBTK InhibitorsZanubrutinibPhase III Clinical TrialStudy MANGROVE(BGB-3111-306, Registration Number: NCT04002297)Achieve Positive Results。

Source: Corporate Announcement

MANGROVE is aA Global, Randomized, Open-Label Phase III Clinical Trial Designed to Evaluate Zanubrutinib in Combination with RituximabControl: Bendamustine Combined with Rituximab, for sleeveCellular Lymphoma（MCL）Adult Patients with Initial TreatmentEfficacy and Safety of Treatment. The study enrolled 510 patients across 176 research centers worldwide. The primary endpoint of the study wasIRC-assessed PFS.

The study results showed that zanubrutinib in combination with rituximab, compared to bendamustine in combination with rituximab,Reduces the risk of disease progression or death by 43%（HR=0.57；p<0.0001）, achieving the primary endpoint of PFS.Its safety profile was consistent with the known safety profiles of the two drugs, and no new safety signals were identified. Data for the key secondary endpoint of overall survival (OS) were not yet mature at the time of this analysis; however, it has been observed thatA Clear Trend Favoring Zanubrutinib in Combination with RituximabOS will be assessed in the final analysis.

It is worth mentioning that MANGROVE isFirstEvaluation of BTK Inhibitor-BasedNon-chemotherapy RegimenA global, randomized Phase III clinical study comparing with standard immunochemotherapy regimens. The positive results from this pivotal Phase III clinical study are expected to strengthen the clinical evidence base for zanubrutinib in the field of mantle cell lymphoma (MCL).

BeOne will present the full results of the MANGROVE study, including efficacy and safety data, at upcoming medical conferences, and plans toSecond Half of 2026Conduct global regulatory registration filings.

According to BeOne’s 2025 annual financial report, its full-year product revenue reached RMB 37.77 billion, representing a year-on-year increase of 39.9%, primarily driven by sales growth of zanubrutinib, Amgen-licensed products, and tislelizumab. Among these,Zanubrutinib Revenue Hits New Record High,Global sales reached RMB 28.067 billion, a year-on-year increase of 48.8%.

Edit：ccai

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