Bristol‑Myers Squibb announced that the interim results of its Phase 2/3 SUCCESSOR‑2 study of oral mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma were positive.
The SUCCESSOR‑2 study is a multicenter, randomized, open‑label trial that compares MeziKd to carfilzomib and dexamethasone alone. Eligible patients had at least one prior line of anti‑myeloma therapy, prior exposure to lenalidomide and an anti‑CD38 monoclonal antibody, and documented disease progression on or after their most recent regimen.
The interim analysis showed a statistically significant improvement in progression‑free survival for the MeziKd arm, with safety findings consistent with the known profile of mezigdomide and the combination regimen. The data represent a key milestone that could support a regulatory filing and a future commercial launch.
The positive results validate Bristol‑Myers Squibb’s CELMoD platform and strengthen its oncology pipeline at a time when generic competition is eroding margins on established drugs such as Revlimid and Pomalyst. The company also has another CELMoD agent, iberdomide, for which the FDA has accepted an NDA in combination with daratumumab and dexamethasone, targeting a similar patient population.
"We are excited by these results, which underscore Bristol‑Myers Squibb's leadership in treating multiple myeloma and our unwavering commitment to patients living with this persistent and challenging disease. Importantly, these findings 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," said Cristian Massacesi, executive vice president, chief medical officer and head of development at Bristol‑Myers Squibb.
"It is important for patients to have treatment options that offer enduring disease control. These positive interim data show that adding mezigdomide, a CELMoD specifically optimized for enhanced myeloma cell killing and immune activation compared with IMiD agents, to carfilzomib and dexamethasone may provide clinical benefit in earlier relapse," added Meletios‑A. (Thanos) Dimopoulos, MD, Professor and Chairman, Department of Clinical Therapeutics at Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens.
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