Bristol-Myers Squibb Company (BMS) and AbbVie have announced that results from an interim analysis of its Phase III, randomized, open-label ELOQUENT-2 trial were published in the 2 June nline edition of the New England Journal of Medicine. The trial (n=646) evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with lenalidomide and dexamethasone (ELd) versus lenalidomide and dexamethasone alone (Ld) for the treatment of relapsed or refractory multiple myeloma. The study met its co-primary endpoints demonstrating superior progression-free survival (PFS) and overall response rate (ORR).
The ELd arm demonstrated a 30% reduction in the risk of disease progression or death compared to the Ld arm (HR 0.70, 95% CI, [0.57, 0.85]; p = 0.0004). The PFS rates in the ELd arm versus the Ld arm were 68% versus 57% at 1 year and 41% versus 27% at 2 years, respectively. A significant ORR also was observed with 79% (74% to 83%) in the ELd arm compared to 66% (60% to 71%) in the Ld arm (odds ratio, 1.9; 1.4 to 2.8; p=0.0002). The safety profile was consistent with previously-reported studies and there were minimal incremental adverse events (AEs) with the addition of elotuzumab to lenalidomide and dexamethasone.
“Despite advances in treatment, multiple myeloma remains a largely incurable disease,” said lead author Sagar Lonial, chief medical officer of the Winship Cancer Institute of Emory University School of Medicine. “These ELOQUENT-2 data are significant because they show that adding elotuzumab to the standard treatment yielded an impressive reduction in the risk of disease progression, which was maintained over time, demonstrating the benefit of an immune-based approach in multiple myeloma.”
