Phase III data shows combination treatment with Empliciti (elotuzumab) extends PFS in multiple myeloma- BMS

BMS has presented extended follow-up data and a pre-specified interim overall survival (OS) analysis of Empliciti (elotuzumab) in combination with Revlimid (lenalidomide) and dexamethasone (ERd) in patients with relapsed or refractory multiple myeloma from the randomized, open-label, Phase III study ELOQUENT-2. The follow-up data demonstrated that Empliciti in combination with Rd had an improvement in progression-free survival (PFS) versus Rd alone. This result was consistent with the improvement in PFS that was observed at the time of the primary analysis. The Empliciti combination delayed the need for subsequent myeloma therapy by a median of one year compared to Rd alone.

A pre-specified interim analysis of OS found a positive trend favoring the Empliciti combination versus Rd alone, though at the time of the interim analysis the OS endpoint had not reached the pre-determined threshold for statistical significance. Patients will continue to be followed for survival. Updated safety and tolerability data were consistent with previous findings. Common Grade 3 or 4 adverse events included neutropenia (26%), anemia (15%), fatigue (9%), and diarrhea (5%). These data were presented at the 57th American Society of Hematology (ASH) Annual Meeting.

Comment: Empliciti was recently approved by the FDA for multiple myeloma. Darzalex (daratumumab) from Janssen Biotech, also recently approved, is the only other FDA-approved monoclonal antibody for the treatment of patients with multiple myeloma. Other recently approved drugs for multiple myeloma are Pomalyst (pomalidomide) from Celgene and Darzalex (daratumumab) from Janssen Biotech.The potential market leader may be Kyprolis (carfilzomib) from Amgen.