Bristol Myers Squibb reached a major milestone in its next-generation protein degradation program on Monday, reporting that its oral CELMoD agent, mezigdomide, significantly extended the time patients lived without their cancer progressing in a pivotal Phase 3 study.
The company announced that the Phase 3 SUCCESSOR-2 trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS).
The study evaluated the combination of oral mezigdomide, carfilzomib, and dexamethasone (MeziKd) against the standard carfilzomib and dexamethasone (Kd) regimen in patients with relapsed or refractory multiple myeloma (RRMM).
Mezigdomide is part of the company’s Cereblon E3 Ligase Modulator (CELMoD) platform, designed for enhanced tumor cell killing and immune activation compared to older immunomodulatory (IMiD) agents like lenalidomide.
The success of SUCCESSOR-2 is particularly notable for patients previously exposed to anti-CD38 therapies, a group that currently faces limited effective options upon relapse.
Safety findings in the interim analysis were consistent with the established profiles of the individual agents, and no new safety signals were identified.
Patients in the trial will continue to be monitored for long-term overall survival and safety outcomes.
Bristol Myers Squibb plans to present the full data set from the SUCCESSOR-2 study at an upcoming medical congress and will begin discussions with global health authorities regarding regulatory submissions.