Bristol Myers Squibb’s mezigdomide has scored its first phase 3 win, with the Cereblon E3 ligase modulator (CELMoD) tied to a statistically significant improvement in progression-free survival (PFS) among multiple myeloma patients.
The Successor-2 trial compared a combination of mezigdomide, Amgen’s cancer drug Kyprolis (carfilzomib), and the corticosteroid dexamethasone with carfilzomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The oral mezigdomide regimen hit the study’s primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in PFS, the company said in a March 9 release.
Safety findings were “consistent with the known profile of mezigdomide and the combination regimen,” said BMS, which is continuing the study so it can assess the key secondary endpoint of overall survival.
The company is holding back detailed data for a future medical conference and said it will also share the findings with health authorities.
The positive mezigdomide data comes six months after BMS’ CELMoD program scored another hit when a combination of iberdomide, the approved CD38 drug Darzalex and the steroid dexamethasone met one of the dual primary endpoints in a phase 3 multiple myeloma trial.
BMS’ Chief Medical Officer, Cristian Massacesi, M.D., said this morning’s mezigdomide results “reinforce the value of our CELMoD program and our targeted protein degradation platform, and strengthen our confidence in bringing forward effective, accessible oral treatment options for patients with difficult-to-treat blood cancers and potentially beyond.”
William Blair analysts said they continue to believe the CELMoD program “has potential to be a key long-term growth driver” for BMS. While this morning’s data are helping build momentum for mezigdomide, they suggested that the “most strategically important readout” for mezigdomide will be a head-to-head study against BMS’ myeloma drug Pomalyst, which is expected to deliver data next year.
Meanwhile, BMS is evaluating iberdomide against its own Revlimid and is expecting to read out a phase 2 study of another CELMoD drug, golcadomide, later this year.
