Bristol Myers Squibb Announces Positive Phase 3 MRD Endpoint Results for Iberdomide in Relapsed or Refractory Multiple Myeloma
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
Recently (September 23, 2025),Bristol-Myers Squibb (BMS) announced that its investigational drugPhase 3 Trial of Iberdomide in Multiple MyelomaEXCALIBER-RRMMIn China, one of the two primary endpointsThe negative rate of minimal residual disease (MRD) has achieved a statistically significant improvement.
Despite, the research is still ongoing to evaluateAnother dual primary endpoint, progression-free survival (PFS), as well as the key secondary endpoints of overall survival and safety.
BMS stated that it will discuss these results with health authorities. This has drawn widespread attention in the market——Whether iberdomide can rely onCan the surrogate endpoint MRD gain FDA approval?
Iberdomide is a moleculeCollagen-degrading drugs, belonging to a new generationCereblon E3 Ligase Modulator (CELMoD™) exerts its anticancer effects by targeting the degradation of key transcription factors, such as Aiolos and Ikaros.
Iberdomide is a BMS acquisitionOne of the three protein degradation drugs obtained by Celgene is positioned by BMS asBlockbuster blood cancer drugs like Revlimid and PomalystSuccessor of the object.
iberdomideA Phase 3 trial is ongoing.EXCALIBER-RRMM, aiming to evaluateIberdomide CombinationDaratumumab and Dexamethasone (IberDd）Comparison of Daratumumab, Bortezomib, and Dexamethasone (DVd) in Relapsed or Refractory Multiple Myeloma (RRMM)) Efficacy and safety in patients.The study aims to evaluate two co-primary endpoints: minimal residual disease (MRD) negativity and progression-free survival (PFS). Secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), time to progression (TTP), time to next treatment (TTNT), and health-related quality of life (HR-QoL). The first phase of the study determined a dose of 1.0 mg based on safety, pharmacokinetic, and efficacy data.iberdomideFor the optimal dose. In the second phase, approximately 664 patients were randomly assigned to receive IberDd or DVd treatment.
At the planned interim analysis of the MRD endpoint, iberdomide combined with daratumumab + dexamethasone showed results compared to the control group.Achieved a statistically significant improvement in the minimal residual disease (MRD) negative rate.
According to the trial design and based on the recommendation of the Data Monitoring Committee, the trial will continue without any changes to evaluate another primary endpoint as well as key secondary endpoints.
In this studyiberdomideThe safety of combination of daratumumab and dexamethasone was generally consistent with previous studies.
In fact, MRD asIberdomide Accelerated ApprovalThe surrogate endpoint was unanimously supported by experts at the committee meeting held by the FDA in 2024.
However, in the first half of 2025, the FDA underwent a major reorganization, given the recent FDA's attitude towards drug approval.Transformation,Whether iberdomide can rely onThe substitution of MRD as an endpoint for regulatory approval may be subject to uncertainty.
If,FDA continues its previous stance,Iberdomide has the potential to become the first drug approved based on the alternative endpoint MRD.
At the same time, according to market forecasts,If iberdomide is successfully approved, it will have considerable market potential and become an important driver of future revenue growth for BMS.Leerink Partners analyst David Risinger wrote in a report in July this year that consensus estimatesIberdomide is expected to generate approximately $1.3 billion in annual sales by 2035.
In fact,The success of iberdomide in the MRD endpoint is a significant boost for BMS this year — this year, BMS has successively experienced Phase 3 failures in melanoma, cardiomyopathy, and schizophrenia.
References:
1.https://www.businesswire.com/news/home/20250923828240/en/Bristol-Myers-Squibb-Announces-Phase-3-EXCALIBER-RRMM-Study-Evaluating-Iberdomide-in-Combination-with-Standard-Therapies-Demonstrated-a-Significant-Improvement-in-Minimal-Residual-Disease-Negativity-Rates-in-Relapsed-or-Refractory-Multiple-Myeloma
2.https://www.fiercebiotech.com/biotech/bristol-myers-mid-trial-endpoint-addition-secures-phase-3-win-multiple-myeloma
3.https://www.biopharmadive.com/news/bristol-myers-iberdomide-multiple-myeloma-study-results-excaliber/760845/
