BeOne Medicines Ltd. (06160) announced positive results from the Phase 3 clinical trial of BaoYueZe frontline treatment kit for lymphoma.

BeOne Medicines Ltd. announced that the MANGROVE Phase 3 clinical trial (BGB-3111-306; NCT04002297) has achieved positive results. The study aimed to evaluate the company's independently developed cornerstone product BTK inhibitor zanubrutinib (Brukinsa) in combination with rituximab, compared to bendamustine in combination with rituximab (BR), for the first-line treatment of adult patients with mantle cell lymphoma (MCL). MANGROVE is the first global, randomized Phase 3 clinical trial to evaluate a chemotherapy-free regimen based on BTK inhibitors compared to standard immunochemotherapy in this treatment setting. The positive results of this crucial Phase 3 clinical trial are expected to strengthen the clinical evidence base for zanubrutinib in the field of MCL. Chief Medical Officer in Hematology, Medical and Human Genetics/Cancer Dr. Amit Agarwal of BeOne Medicines Ltd. stated: "For newly diagnosed MCL patients, chemotherapy is the current standard treatment choice. The MANGROVE study has shown for the first time that the chemotherapy-free regimen of zanubrutinib in combination with rituximab can bring significant improvement in progression-free survival (PFS) and has the potential to reshape the treatment landscape globally. We believe that reducing the burden of frequent infusions due to chemotherapy is important for patients. This study further validates the potential of zanubrutinib as a cornerstone BTK inhibitor in this disease area: not only providing important evidence for its expansion to first-line treatment for MCL, but also continuing to strengthen its leading role in the treatment of B-cell malignancies." In the prespecified interim analysis, the MANGROVE study met the primary endpoint of PFS. As assessed by an independent review committee (IRC), zanubrutinib in combination with rituximab showed a significantly improved PFS compared to the BR regimen, with both high statistical significance and clinical relevance. This is the first Phase 3 study exploring a chemotherapy-free and rituximab-free maintenance treatment regimen in first-line MCL therapy, which is expected to help patients reduce the burden of infusions by about two years. Data showed that the chemotherapy-free regimen based on zanubrutinib reduced the risk of disease progression or death by 43% (HR=0.57; [95% CI, 0.43, 0.76]; p<0.0001). Its safety profile was consistent with the known safety profile of both drugs, with no new safety signals identified. The key secondary endpoint of overall survival (OS) was not mature at the time of this analysis, but a favorable trend towards zanubrutinib in combination with rituximab was observed. OS will be evaluated in the final analysis. BeOne Medicines Ltd. plans to announce the full results of the MANGROVE study at an upcoming medical conference, and is in communication with global regulatory agencies regarding the related registration submission plan, with plans to submit in the second half of 2026.