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Bristol Myers’ Iberdomide Combo Hits MRD Goal in Phase 3 Myeloma Study

Regulatory decisions will hinge on forthcoming progression and survival outcomes.

Overview

  • A planned interim readout from the EXCALIBER-RRMM trial found iberdomide plus daratumumab and dexamethasone achieved significantly higher minimal residual disease–negativity rates than daratumumab, bortezomib and dexamethasone.
  • On a recommendation from the Data Monitoring Committee, the study will continue without changes to assess the co-primary endpoint of progression-free survival as well as overall survival and safety.
  • The two-stage, multicenter trial selected a 1.0 mg dose of iberdomide during stage 1 and then randomized approximately 664 patients in stage 2 to the investigational regimen versus the control arm.
  • Investigators report a safety profile for the iberdomide combination that is generally consistent with prior studies.
  • Bristol Myers plans to discuss the data with health authorities, and analysts view the MRD result as a positive sign while noting that PFS and upcoming head-to-head trials will define the drug’s role and commercial potential.