ZENBEXUS combination more than doubles median progression-free survival in Phase III multiple myeloma study

Bristol Myers Squibb has reported positive Phase III findings showing that ZENBEXUS, also known as iberdomide, in combination with daratumumab and dexamethasone significantly improved progression-free survival in patients with relapsed or refractory multiple myeloma.

The results come from the EXCALIBER-RRMM study, which enrolled 800 patients with multiple myeloma from as early as their first relapse.

The ZENBEXUS combination, known as ZDd, was compared with the standard regimen of daratumumab, bortezomib and dexamethasone, or DVd.

Median progression-free survival reached 42 months with ZDd compared with 20 months in the DVd group.

The hazard ratio was 0.49, with a p value below 0.000001, representing a 51% reduction in the risk of disease progression or death.

Median follow-up at the time of the analysis was 23 months.

Progression-free survival was one of two dual primary endpoints in EXCALIBER-RRMM.

The new findings build on previously reported results showing that ZDd improved rates of minimal residual disease negative complete response compared with DVd.

Those earlier MRD findings supported U.S. Food and Drug Administration approval of ZENBEXUS for relapsed or refractory multiple myeloma.

Cristian Massacesi, MD, Chief Medical Officer and Head of Development at Bristol Myers Squibb, said the progression-free survival results demonstrate that the previously observed improvements in minimal residual disease translated into a meaningful delay in disease progression.

He said the findings also support the potential role of ZENBEXUS as an oral treatment option that can be used across different care settings, including community oncology practices.

The safety profile of ZENBEXUS in combination with standard treatments remained consistent with previously reported findings from the EXCALIBER-RRMM study.

No new safety findings were highlighted in the topline analysis.

Detailed results from the progression-free survival analysis are expected to be presented at the 68th Annual Meeting of the American Society of Hematology in New Orleans.

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