FDA Accepts Supplemental Biologics License Application for Triplet Myeloma Therapy
Posted: Wednesday, August 29, 2018
The U.S. Food and Drug Administration (FDA) recently accepted Bristol-Myers Squibb’s supplemental Biologics License Application for elotuzumab (Empliciti), an immunostimulatory antibody that targets the cell-surface glycoprotein SLAMF7, in combination with pomalidomide and low-dose dexamethasone in the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Data from this study were presented at the 2018 European Hematology Association (EHA) Annual Congress (Abstract LB2606) and previously covered by JNCCN 360.
The application is based on data from the phase II ELOQUENT-3 study, which evaluated the triplet regimen in patients with relapsed or refractory multiple myeloma. ELOQUENT-3 randomized 117 patients to receive elotuzumab, pomalidomide, and low-dose dexamethasone (n = 60) or pomalidomide and dexamethasone (n = 57) in 28-day cycles until disease progression or unacceptable toxicity.
Patients receiving the triplet combination therapy experienced a 46% reduction in the risk of disease progression compared with patients who received the doublet regimen, with a median progression-free survival of 10.3 months versus 4.7 months, respectively. The safety profile for the triplet combination was consistent with prior findings for elotuzumab and pomalidomide regimens.