Bristol Myers Squibb’s (BMS’s) Phase III trial of Zenbexus (iberdomide) has more than doubled progression-free survival (PFS) in patients with multiple myeloma (MM).
In the EXCALIBER-RRMM study (NCT04975997), there was a statistically significant improvement in the dual-primary endpoint of PFS, with median PFS of 42 months for patients who received Zenbexus compared to 20 months for those who received daratumumab, bortezomib and dexamethasone (DVd).
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This represents a 51% reduction in the risk of disease progression or death, meeting the trial’s second primary endpoint with statistical significance.
The data builds on previously reported improvements in minimal residual disease (MRD)-negative complete response, the other dual-primary endpoint.
This endpoint success led to the US Food and Drug Administration’s (FDA) approval of the drug for relapsed/refractory (R/R) MM on 13 August 2026. This is the first time that MRD was used for accelerated approval in MM after the FDA approved this as an intermediate endpoint in 2024.
The safety profile of Zenbexus in combination with standard therapies remained consistent with previously reported safety findings from the study.
Dr Cristian Massacesi, CMO of BMS, said: “The results from EXCALIBER-RRMM reinforce the clinical value of Zenbexus in combination with daratumumab and dexamethasone as a treatment approach for relapsed or refractory multiple myeloma, demonstrating the strong benefit observed for minimal residual disease negativity translated to a meaningful improvement in progression-free survival for patients. These findings further underscore the value of Zenbexus as an effective oral treatment option that can be easily used in diverse care settings, including community settings, where many patients receive their care. We look forward to sharing full results from the study.”
The new data will be presented at the 68th Annual Meeting of the American Society of Hematology in New Orleans, which is taking place from 12 to 15 December.
Multiple myeloma market is growing
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 (daratumumab). 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).
GlobalData is the parent company of Clinical Trials Arena.
