BMS’s Zenbexus meets PFS endpoint in pivotal multiple myeloma trial
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Bristol Myers Squibb's (BMS's) Phase III trial of Zenbexus (iberdomide) has more than doubled progression-free survival (PFS) in patients with multiple myeloma (MM). In the EXCALIBER-RRMM study (NCT04975997), there was a statistically significant improvement in the dual-primary endpoint of PFS, with median PFS of 42 months for patients who received Zenbexus compared to 20 months for those who received daratumumab, bortezomib and dexamethasone (DVd). The gold standard of business intelligence. Find out more Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms. Find out more This represents a 51% reduction in the risk of disease progression or death, meeting the trial's second primary endpoint with statistical significance. The data builds on previously reported improvements in minimal residual disease (MRD)-negative complete response, the other dual-primary endpoint. This endpoint success led to the US Food and Drug Administration's (FDA) approval of the drug for relapsed/refractory (R/R) MM on 13 August 2026. This is the first time that MRD was used for accelerated approval in MM after the FDA approved this as an intermediate endpoint in 2024. The safety profile of Zenbexus in combination with standard therapies remained consistent with previously reported safety findings from the study. Dr Cristian...
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