Adding elotuzumab to pomalidomide and low-dose dexamethasone can improve progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM), according to the ELOQUENT-3 trial.
These results support the recent U.S. approval of elotuzumab, pomalidomide, and dexamethasone in adults with MM who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
Results from ELOQUENT-3 were recently published in The New England Journal of Medicine and previously presented at the 23rd Congress of the European Hematology Association in June.
The phase 2 trial included patients with refractory or relapsed and refractory MM who had received lenalidomide and a proteasome inhibitor.
The patients were randomized to receive elotuzumab plus pomalidomide and low-dose dexamethasone (EPd, n=60) or pomalidomide and low-dose dexamethasone (Pd, n=57) in 28-day cycles until disease progression or unacceptable toxicity.
The overall response rate was 53% in the EPd arm and 26% in the Pd arm (odds ratio=3.25; P=0.0029).
There were two stringent complete responses (CRs) and three CRs in the EPd arm, and there was one CR in the Pd arm.
The median duration of response was 8.3 months in the Pd arm and was not reached in the EPd arm.
The median PFS was 10.3 months with EPd and 4.7 months with Pd (hazard ratio=0.54, P=0.008).
Overall survival data were not mature at the time of analysis, but there was a trend favoring EPd over Pd (hazard ratio=0.62). There were 13 deaths in the EPd arm and 18 in the Pd arm.
The most common treatment-related adverse events (in the EPd and Pd arms, respectively) were neutropenia (18% and 20%), hyperglycemia (18% and 11%), and anemia (10% and 15%).
This trial was supported by Bristol-Myers Squibb and AbbVie Biotherapeutics, and researchers reported relationships with several other companies.