Bristol Myers Squibb’s (BMS’s) investigational cereblon E3 ligase modulator iberdomide has shown promise in a mid-stage endpoint of a multiple myeloma trial.
The ongoing Phase III EXCALIBER-RRMM study (NCT04975997) is evaluating iberdomide in combination with standard of care (SoC) therapies, notably Darzalex (daratumumab) and dexamethasone, in patients with relapsed or refractory multiple myeloma (r/r MM).
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In interim data, patients treated with iberdomide saw a statistically significant improvement in minimal residual disease (MRD) negativity rates when compared to the control arm, in a planned interim analysis of the MRD primary endpoint.
Based on the interim analysis, the trial will continue without changes to evaluate the other dual-primary endpoint of progression-free survival (PFS), and the key secondary endpoints of overall survival (OS) and safety.
The safety profile of iberdomide in combination with daratumumab and dexamethasone remains consistent with previous studies.
BMS senior vice-president Anne Kerber said: “This result builds on our significant experience in both targeted protein degradation and developing new treatment options for patients living with multiple myeloma. Iberdomide represents the first of a novel class of medicines, called CELMoDs, which have the potential to create a new foundation for multiple myeloma treatment that may be combined with other therapies.”
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By GlobalDataBMS said it plans to discuss these results with health authorities. In 2024, a US Food and Drug Administration (FDA) Advisory Committee (AdCom) voted to support a new intermediate endpoint of MRD for accelerated approvals in multiple myeloma, suggesting this may be BMS’s intention. This approval pathway has not been used as of yet.
This month, Johnson & Johnson (J&J) announced its MM combination of Tecvayli (teclistamab-cqyv) and Darzalex Faspro (daratumumab and hyaluronidase-fihj) as an induction treatment elicited a 100% overall response (OR) in transplant-eligible, newly diagnosed patients.
Multiple myeloma market set for growth
Each year, more than 35,000 new cases of multiple myeloma are diagnosed in the US, and nearly 13,000 patients die from the disease.
Currently, initial MM treatment includes Velcade (bortezomib), Revlimid (lenalidomide), and Darzalex. In cases of relapse, Kyprolis (carfilzomib) and Pomalyst (pomalidomide) are used.
GlobalData analysis predicts the multiple myeloma market is expected to grow to $29bn in 2032, with the US to remain the dominant region across the eight major markets (8MM: the US, France, Germany, Italy, Spain, the UK, Japan, and China).
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