Bristol Myers Squibb ZENBEXUS cuts progression risk 51%

• Bristol Myers Squibb (NYSE:BMY) said the Phase 3 EXCALIBER-RRMM study met its progression-free survival endpoint in relapsed or refractory multiple myeloma.
• Median progression-free survival was 42 months with ZENBEXUS-based treatment versus 20 months with the comparator regimen.
• The company reported a 51% reduction in the risk of disease progression or death, with no new safety findings highlighted.

Bristol Myers Squibb (NYSE:BMY) reported positive Phase 3 EXCALIBER-RRMM results showing median progression-free survival of 42 months with ZENBEXUS-based treatment versus 20 months with the comparator regimen.

The study enrolled 800 patients with relapsed or refractory multiple myeloma and reported a hazard ratio of 0.49 with p<0.000001, which Bristol Myers Squibb said represented a 51% reduction in the risk of disease progression or death.

“The results from EXCALIBER-RRMM reinforce the clinical value of ZENBEXUS in combination with daratumumab and dexamethasone as a treatment approach for relapsed or refractory multiple myeloma,” said Bristol Myers Squibb Chief Medical Officer and Head of Development Cristian Massacesi.

The confirmatory analysis included 400 patients assigned to ZENBEXUS, daratumumab and dexamethasone and 400 assigned to daratumumab, bortezomib and dexamethasone, with median follow-up of 23 months.

Bristol Myers Squibb said the safety profile remained consistent with earlier findings and plans to present full results at the American Society of Hematology annual meeting.

The progression-free survival result builds on earlier findings showing improvement in minimal residual disease-negative complete response, which supported the FDA’s accelerated approval of ZENBEXUS in this treatment setting.

ZENBEXUS is approved with daratumumab and hyaluronidase-fihj plus dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.