European Investor
08 Oct 2026, 16:41
Bristol Myers Squibb Reports Strong Phase 3 Results for ZENBEXUS in Relapsed Multiple Myeloma
Bristol Myers Squibb reported positive Phase 3 results for ZENBEXUS, or iberdomide, in combination with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma.
In the EXCALIBER-RRMM study, the combination reduced the risk of disease progression or death by 51% compared with daratumumab, bortezomib and dexamethasone. Median progression-free survival reached 42 months with ZENBEXUS versus 20 months for the control regimen, with a hazard ratio of 0.49 and a highly statistically significant result.
The trial enrolled 800 patients who had received one or two prior lines of therapy. The progression-free survival result builds on previously reported improvements in minimal residual disease-negative complete response, which supported the drug’s U.S. accelerated approval.
Bristol Myers said the safety profile remained consistent with previously reported findings. ZENBEXUS is an oral CELMoD therapy and is being positioned as a potential treatment option that can be used across a broader range of care settings, including community practices.
The new data are important because they provide stronger confirmatory evidence of clinical benefit beyond response depth alone. A near-doubling of median progression-free survival materially strengthens the treatment’s efficacy profile and could support broader physician adoption if the benefit remains durable in longer follow-up.
Bristol Myers Squibb reported positive Phase 3 results for ZENBEXUS, or iberdomide, in combination with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma.
In the EXCALIBER-RRMM study, the combination reduced the risk of disease progression or death by 51% compared with daratumumab, bortezomib and dexamethasone. Median progression-free survival reached 42 months with ZENBEXUS versus 20 months for the control regimen, with a hazard ratio of 0.49 and a highly statistically significant result.
The trial enrolled 800 patients who had received one or two prior lines of therapy. The progression-free survival result builds on previously reported improvements in minimal residual disease-negative complete response, which supported the drug’s U.S. accelerated approval.
Bristol Myers said the safety profile remained consistent with previously reported findings. ZENBEXUS is an oral CELMoD therapy and is being positioned as a potential treatment option that can be used across a broader range of care settings, including community practices.
The new data are important because they provide stronger confirmatory evidence of clinical benefit beyond response depth alone. A near-doubling of median progression-free survival materially strengthens the treatment’s efficacy profile and could support broader physician adoption if the benefit remains durable in longer follow-up.
