Key Takeaways
- Bristol Myers Squibb’s mezigdomide shows significant improvement in progression-free survival for multiple myeloma patients in phase 3 trial.
- The Successor-2 trial compared mezigdomide with Amgen’s Kyprolis and dexamethasone against the latter drugs alone, achieving its primary endpoint.
- Detailed results are set to be disclosed at an upcoming medical conference as BMS continues to evaluate overall survival.
Mezigdomide’s Phase 3 Success
Bristol Myers Squibb (BMS) has announced its first phase 3 success for mezigdomide, a Cereblon E3 ligase modulator (CELMoD), which demonstrated a statistically significant improvement in progression-free survival (PFS) for patients with relapsed or refractory multiple myeloma.
The Successor-2 trial assessed the effects of mezigdomide, in combination with Amgen’s cancer drug Kyprolis (carfilzomib) and the corticosteroid dexamethasone, compared to the combination of carfilzomib and dexamethasone alone. The trial met its primary endpoint, showcasing a significant and clinically meaningful enhancement in PFS, as reported by BMS in a release on March 9.
According to the company, the safety profile of mezigdomide remained consistent with prior data. BMS will continue the study to further evaluate the secondary endpoint of overall survival, with plans to release detailed results at a future medical conference. They will also share these findings with health authorities.
The positive outcomes follow a previous success in the CELMoD program. Six months prior, a combination involving iberdomide, the approved CD38 drug Darzalex, and dexamethasone met one of the dual primary endpoints in a separate phase 3 multiple myeloma trial.
Cristian Massacesi, M.D., BMS’ Chief Medical Officer, expressed that the mezigdomide results further emphasize the value of the CELMoD program and the targeted protein degradation platform, bolstering confidence in the development of effective and accessible oral treatments for challenging blood cancers.
Analysts from William Blair view the CELMoD program as having significant long-term growth potential for BMS. They noted that while the recent data adds momentum for mezigdomide, the most crucial indicator for its future will be the head-to-head study against Pomalyst, another myeloma drug from BMS, expected to provide results next year.
In addition, BMS is currently evaluating iberdomide against its own Revlimid and anticipates results from a phase 2 study of another CELMoD drug, golcadomide, later this year. This strategic focus aims to enhance treatment options for patients with difficult-to-treat multiple myeloma and similar conditions.
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