Bristol Myers Squibb & Co. (NYSE:BMY) on Tuesday announced results from the Phase 3 EXCALIBER-RRMM study evaluating iberdomide, an investigational cereblon E3 ligase modulator (CELMoD), combined with standard therapies (daratumumab + dexamethasone) in patients with relapsed or refractory multiple myeloma (RRMM).
The trial demonstrated a statistically significant improvement in minimal residual disease (MRD) negativity rates, compared with the control arm, in a planned interim analysis of the MRD endpoint.
In accordance with the trial design and based on the recommendation from the Data Monitoring Committee, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoint of overall survival and safety.
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The safety profile of iberdomide in combination with daratumumab and dexamethasone in this study is generally consistent with previous studies.
Bristol Myers Squibb plans to discuss these results with health authorities.
William Blair on Monday said, “As the first Phase III readout for the CELMoD franchise, the initial MRD results for EXCALIBER-RRMM represent a clear win, and we look forward to upcoming PFS data, which will definitively establish the trial's success.”
Analyst Matt Phipps said the most critical CELMoD data will come from head-to-head trials against Revlimid and Pomalyst (EXCALIBER-Maintenance, SUCCESSOR-1, GOLSEEK-4), as these are key to driving the IMiD franchise transition while generics erode sales of the older drugs.
William Blair views CELMoDs as one of the company's most important Phase 3 programs. Combined with late-stage assets like milvexian and the ongoing launch of Cobenfy for schizophrenia, these could support the company's long-term growth.
Price Action: BMY stock is up 0.90% at $45.38 at the last check on Tuesday.
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