MANGROVE tests a chemotherapy-free first-line option
BeOne Medicines reported positive topline results from the Phase 3 MANGROVE study in adults with previously untreated mantle cell lymphoma, or MCL.
The trial found that BRUKINSA plus rituximab cut the risk of progression or death by 43% versus bendamustine plus rituximab. The hazard ratio was 0.57.
According to BeOne, the prespecified interim analysis met the primary endpoint of progression-free survival. An independent review committee assessed that result.
The 95% confidence interval ranged from 0.43 to 0.76. The p value was below 0.0001.
MANGROVE is the first global, randomised Phase 3 trial to test a BTK inhibitor-based chemotherapy-free regimen against standard chemoimmunotherapy in first-line MCL.
It is also the first Phase 3 study in frontline MCL to use a chemotherapy-free regimen without rituximab maintenance, which could spare patients about 2 years of infusions.
Amit Agarwal, M.D., Ph.D., chief medical officer for hematology at BeOne Medicines, said: “For patients with newly diagnosed MCL, chemotherapy is currently the default.”
He added that MANGROVE showed for the first time that BRUKINSA plus rituximab improved progression-free survival and could change treatment practice globally.
510 patients at 176 sites
In the study arm, adults received BRUKINSA, also called zanubrutinib, at 160 mg twice daily by mouth plus rituximab during the initial treatment period.
After that period, patients in the BRUKINSA arm stayed on BRUKINSA alone until disease progression or unacceptable toxicity.
Meanwhile, the control arm received bendamustine plus rituximab for 6 cycles.
BeOne said the safety profile of BRUKINSA plus rituximab matched the known safety profile of both medicines. The company reported no new safety signals.
Survival was immature at the interim analysis. However, BeOne reported a strong trend in favour of BRUKINSA plus rituximab.
Survival remains a key secondary endpoint and will be tested at the final analysis.
BeOne Medicines Ltd.
The company said full MANGROVE efficacy and safety results will be presented at an upcoming medical meeting. Global regulatory submissions are planned for the second half of 2026.
Agarwal said, “We believe it would be very meaningful for patients to be free from the burden of frequent infusions.”
BeOne announced the topline data from San Carlos, California, and called MANGROVE a pivotal Phase 3 trial in frontline mantle cell lymphoma.
