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, its experimental protein-degrading drug for multiple myeloma. The study, known as Excaliber-RRMM, evaluated iberdomide in combination with Darzalex and dexamethasone against a standard regimen in patients with relapsed or refractory multiple myeloma.

Iberdomide Meets Primary Endpoint

The iberdomide combination met one of its primary endpoints, demonstrating a significant improvement in minimal residual disease (MRD) negativity rates compared to the control arm. 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 study achieved this key objective. However, the trial will continue to evaluate other critical endpoints, 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, BMS's then-chief medical officer, emphasized the importance of evaluating "the totality of the data" and ensuring that other endpoints are "moving in the right direction" to support regulatory submissions.

The company plans to submit these interim results to health regulators, marking a significant step in iberdomide's development journey. However, full approval may hinge on the drug's performance in progression-free survival and overall survival measures.

Strategic Importance for Bristol Myers Squibb

Iberdomide represents a crucial component of BMS's strategy to maintain its strong position in the multiple myeloma market. As one of three protein-degrading drugs in the company's pipeline, iberdomide is being positioned as a potential successor to BMS's blockbuster blood cancer drugs Revlimid and Pomalyst.

These legacy products, acquired through the Celgene merger, have been major revenue drivers for BMS. Revlimid reached peak sales of nearly $13 billion in 2021, while Pomalyst recorded $3.5 billion in sales in 2024. With many of BMS's cancer drugs plateauing or declining, the success of iberdomide could be crucial for the company's future growth in oncology.

Financial analysts are closely watching iberdomide's progress. Leerink Partners analyst David Risinger noted that consensus estimates project iberdomide to generate around $1.3 billion in annual sales by 2035. However, Risinger suggested that promising data from the Excaliber-RRMM trial could lead to "substantial upside" to these projections.