Bristol touts its first pivotal celmod win

Bristol Myers Squibb has reported positive topline results on one of two primary endpoints of its pivotal trial evaluating iberdomide, one of the company’s celmods and a potential follow-on to Revlimid. The Excaliber-RRMM study, evaluating iberdomide plus Darzalex and dexamethasone in relapsed/refractory multiple myeloma, demonstrated a statistically significant improvement in MRD negativity rates versus Darzalex, Velcade and dexamethasone, Bristol said on Tuesday. However, no numbers have been disclosed so far, leaving the magnitude of the effect unknown. Separately, it’s unclear whether MRD negativity rates will be sufficient to support accelerated approval. When asked about this at the Morgan Stanley Conference earlier this month, Bristol noted that the study had already been reviewed with the FDA, but added that there were now new members at the agency, so this will need to be addressed again. Bristol plans to share the results with regulators, but even if MRD negativity data are not enough for accelerated approval, the latest news could be a good signal for the other co-primary endpoint, PFS, with data expected in 2026.

Bristol’s pivotal-stage cereblon E3 ligase modulators (celmods)

Source: OncologyPipeline.