Bristol Myers Squibb's ZENBEXUS Doubles MRD-Negative Response Rate in Phase 3 Myeloma Trial

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Bristol Myers Squibb announced the first presentation of results from the pivotal Phase 3 EXCALIBER-RRMM trial showing that ZENBEXUS, or iberdomide, in combination with daratumumab and dexamethasone doubled minimal residual disease-negative complete response rates compared with daratumumab, bortezomib and dexamethasone, at 41.1% versus 20.7%. The data, presented at the 23rd Annual Meeting of the International Myeloma Society in Glasgow and simultaneously published in The Lancet Oncology, covered 420 evaluable patients at a median follow-up of 15.7 months and showed a statistically significant improvement with an odds ratio of 2.75. Overall response rate was 88.9% with the ZENBEXUS-based triplet versus 76.1% for the comparator, while complete response or better nearly doubled at 45.9% versus 24.9%. Based on these results, ZENBEXUS in combination with daratumumab and hyaluronidase-fihj and dexamethasone received accelerated approval from the U.S. Food and Drug Administration on August 13 for adult patients with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, marking the arrival of a new treatment class. Evaluation of the dual primary endpoint of progression-free survival in the confirmatory analysis cohort of 800 patients is ongoing.

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Bristol-Myers Squibb Company
BMY
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ZENBEXUS (iberdomide) triplet doubled MRD-negative complete response rates in Phase 3 EXCALIBER-RRMM and received FDA accelerated approval, a positive R&D/clinical development for BMS.

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