BEIGENE announced positive results from the MANGROVE Phase 3 clinical trial (BGB-3111-306;NCT04002297).
The study evaluated its foundational, self-developed BTK inhibitor, BRUKINSA® (zanubrutinib), combined with rituximab, compared to bendamustine combined with rituximab (BR), for the first-line treatment of adult patients with previously untreated mantle cell lymphoma (MCL).
MANGROVE is the first global, randomized Phase 3 study in this treatment setting to evaluate a chemotherapy-free regimen based on a BTK inhibitor against a standard immunochemotherapy regimen.
The positive results from this pivotal Phase 3 trial are expected to strengthen the clinical evidence base for zanubrutinib in the MCL disease area.
BEIGENE's Chief Medical Officer, Hematology, Dr. Amit Agarwal, stated: "For newly diagnosed MCL patients, chemotherapy is the current standard treatment option. The MANGROVE study is the first to show that the chemotherapy-free regimen of zanubrutinib combined with rituximab provides a significant improvement in progression-free survival (PFS), potentially reshaping the treatment landscape globally. We believe reducing the burden of frequent infusions associated with chemotherapy is highly meaningful for patients. This study further validates the potential of zanubrutinib as a foundational BTK inhibitor in this disease area: it not only provides important evidence for its expansion into first-line MCL treatment but will also continue to solidify its leading role in treating B-cell malignancies."
In this pre-specified interim analysis, the MANGROVE study met its primary endpoint of PFS.
As assessed by an Independent Review Committee (IRC), zanubrutinib combined with rituximab demonstrated a highly statistically significant and clinically meaningful improvement in PFS compared to the BR regimen.
This is the first such Phase 3 study to explore a chemotherapy-free regimen in first-line MCL treatment that does not rely on rituximab maintenance, potentially helping patients reduce their infusion burden by approximately two years.
Data showed the zanubrutinib-based chemotherapy-free regimen 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 profiles 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; however, a clear trend favoring zanubrutinib combined with rituximab was observed.
OS will be assessed in the final analysis.
BEIGENE plans to present the full results from the MANGROVE study at an upcoming medical conference and is engaging with global regulatory authorities regarding the relevant registration plans, with submissions targeted for the second half of 2026.
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