FDA Approves Empliciti Regimen to Treat Relapsed or Refractory Myeloma

The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.

The approval was based on the phase 2 ELOQUENT-3 trial, in which the addition of Empliciti to Pomalyst and dexamethasone reduced the risk of disease progression or death by 46 percent compared with Pomalyst and dexamethasone alone for patients with relapsed/refractory multiple myeloma.

In the ELOQUENT-3 trial, the median progression-free survival was 10.3 months with the Empliciti combination compared with 4.7 months with Pomalyst plus dexamethasone. The progression-free survival benefit associated with the Empliciti combination regimen was similar, regardless of whether patients had received two to three prior lines of treatment, or four or more lines of treatment.

The objective response rate was 53 percent with Empliciti compared with 26 percent %) in the control arm.

“Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,” Paul Richardson, M.D., clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement.

“This new regimen of Empliciti combined with Pomalyst and dexamethasone not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them. Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients,” added Richardson.

The phase 2 ELOQUENT-3 study enrolled 117 patients with relapsed/refractory multiple myeloma who were randomized to the Empliciti combination (60 patients) or Pomalyst and dexamethasone alone (57 patients). The median age of patients was 67 years and they had received a median of three prior treatments.

Disease progression was the main cause of treatment discontinuation and occurred in 43 percent of patients in the Empliciti arm compared with 56 percent in the control group. Discontinuation due to side effects occurred in 18 percent of patients in the Empliciti arm compared with 24 percent for the control group.

The rates of grade 3/4 neutropenia and anemia were lower with Empliciti versus the control arm, despite longer exposure. Pomalyst dose intensity was similar between groups. Grade 3/4 neutropenia was experienced by 13 percent of patients in the Empliciti group compared with 27 percent for the control arm and grade 3/4 anemia occurred in 10 percent versus 20 percent of patients, respectively. All-grade infections occurred in 65 percent of patients in both treatment arms. Five percent of patients in the Empliciti group experienced infusion reactions that were grade 1/2 in severity.

This article originally appeared on OncLive as, "FDA Approves Elotuzumab Triplet for Myeloma."