Bristol Myers Squibb's Iberdomide Shows Promise in Key Multiple Myeloma Study

Bristol Myers Squibb (BMS) has announced positive interim results from a pivotal Phase 3 clinical trial of iberdomide, a next-generation blood cancer drug positioned to succeed the company's blockbuster franchises Revlimid and Pomalyst. The study, known as Excaliber-RRMM, evaluated iberdomide in combination with Darzalex and dexamethasone for patients with relapsed or refractory multiple myeloma.

Iberdomide Meets Primary Endpoint in Phase 3 Trial

The iberdomide combination met one of its main goals in the trial, demonstrating a significant improvement in minimal residual disease (MRD) negativity rates compared to a standard regimen of Darzalex, dexamethasone, and Velcade. MRD negativity is an important measure of treatment efficacy, indicating a very low number of malignant cells in the bone marrow following treatment.

While specific data were not disclosed, BMS confirmed that the iberdomide-based regimen achieved the primary endpoint. However, the company emphasized that the trial will continue to assess other crucial objectives, including progression-free survival and overall survival.

Regulatory Implications and Future Outlook

Despite the positive interim results, BMS executives have previously indicated that regulatory approval for iberdomide would likely depend on meeting additional objectives beyond MRD negativity. Samit Hirawat, Bristol Myers' chief medical officer at the time of the July conference call, stated, "We would have to look at the totality of the data, that other endpoints are moving in the right direction, because the supportive evidence would be needed from a regulatory perspective."

The company plans to submit the results to health regulators, but the timeline for potential approval remains contingent on the drug's performance across all primary and secondary endpoints.

Iberdomide's Role in BMS's Portfolio Strategy

Iberdomide is one of three protein-degrading drugs that BMS is developing as potential successors to its highly successful blood cancer treatments, Revlimid and Pomalyst. These next-generation drugs work by tagging specific proteins essential for cell survival, marking them for destruction by the body's natural disposal mechanisms.

The strategic importance of iberdomide for BMS cannot be overstated, as many of the company's existing cancer drugs have either plateaued or are experiencing declining sales. Revlimid, which reached peak sales of nearly $13 billion in 2021, and Pomalyst, with $3.5 billion in sales in 2024, represent significant revenue streams that BMS aims to replace and potentially surpass with its new pipeline of protein-degrading drugs.

Industry analysts are closely watching iberdomide's progress. Leerink Partners analyst David Risinger noted in a July report that consensus estimates project iberdomide to generate around $1.3 billion in annual sales by 2035. However, Risinger suggested that "if the iberdomide data are promising, we see substantial upside" to those projections.