Key Takeaways:
Bristol Myers Squibb's CELMoD candidate mezigdomide reduced the risk of disease progression or death by 52% versus standard of care in patients with relapsed or refractory multiple myeloma, based on Phase 3 data presented Friday at the American Society of Clinical Oncology annual meeting.
"The overall survival data is immature, but we already start to see the curves separate at this very early point in time," Anne Kerber, M.D., head of late-stage development for hematology, oncology and cell therapy at Bristol Myers Squibb, said in an interview.
The SUCCESSOR-2 trial enrolled 479 patients who received either mezigdomide plus Amgen's Kyprolis (carfilzomib) and dexamethasone, or Kyprolis and dexamethasone alone. Patients in the mezigdomide arm lived without disease progression for a median of 18 months, compared with 8.3 months for the control group. The complete response rate nearly tripled to 26.7% from 8.9%.
The results mark a potential breakthrough for the CELMoD class of protein degraders, which have not yet received US Food and Drug Administration approval. Mezigdomide is designed to target transcription factors Ikaros and Aiolos, which multiple myeloma cells rely on for survival. The safety profile showed grade 3 or 4 treatment-related adverse events in 83.7% of patients in the mezigdomide arm versus 56.5% in the control group, consistent with prior trials, according to Kerber.
Bristol Myers plans to discuss the data with the FDA in the coming months. The regulator is already reviewing another CELMoD candidate from the company, iberdomide, for the same indication, with a PDUFA date of Aug. 17. The company also presented data at ASCO on golcadomide for newly diagnosed B-cell lymphoma and disclosed more than 60 scientific presentations across its oncology pipeline, including assets such as izalontamab brengitecan and pumitamig.
The mezigdomide data strengthen Bristol Myers' position in multiple myeloma as it faces patent expirations on legacy drugs including Revlimid and Pomalyst. Shares of Bristol Myers traded at $58.03, up 8.5% year to date and 29.9% over the past 12 months. Investors will watch for the FDA's decision on iberdomide in August and for mezigdomide's regulatory filing timeline as the next catalysts for the stock.
This article is for informational purposes only and does not constitute investment advice.
