The phase 3 MANGROVE trial showed that a chemotherapy-free combination of zanubrutinib (Brukinsa) and rituximab (Rituxan) significantly improved progression-free survival compared with standard chemoimmunotherapy as a first-line treatment for mantle cell lymphoma (MCL).
The combination reduced the risk of disease progression or death by 43%. Overall survival data are still early but currently favor the zanubrutinib group. Based on these results, BeOne Medicines plans to seek global approval for frontline use in the second half of 2026.
The trial enrolled 510 previously untreated adults who were older or had health conditions that made them unsuitable for an autologous stem cell transplant.
The most common side effects of zanubrutinib included low neutrophil counts, low platelet counts, and upper respiratory tract infections. Serious risks included bleeding, heart rhythm problems, and infections.
Zanubrutinib is currently FDA-approved for mantle cell lymphoma only after at least one prior treatment. The MANGROVE trial evaluates its use as an initial therapy.
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