FDA Approves Immunotherapy Combination in Relapsed or Refractory Multiple Myeloma
Posted: Thursday, November 8, 2018
On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone in the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Following priority review by the FDA, elotuzumab plus pomalidomide and dexamethasone is the first triplet combination to be approved based on a randomized clinical trial using pomalidomide and dexamethasone as a comparator.
In ELOQUENT-3 (ClinicalTrials.gov identifier NCT02654132), a randomized, open-label, phase II trial, elotuzumab plus pomalidomide and dexamethasone demonstrated benefit in patients with relapsed or refractory multiple myeloma. Patients were randomly assigned 1:1 to receive either elotuzumab plus pomalidomide and dexamethasone (n = 60) or pomalidomide and dexamethasone (n = 57) in 28-day cycles until disease progression or unacceptable toxicity.
Results from the ELOQUENT-3 trial, which were presented at the 23rd Congress of the European Hematology Association in June 2018 (Abstract LB2606), showed the triplet combination reduced the risk of disease progression by 46%, demonstrating a median progression-free survival of 10.25 months vs. 4.67 months for pomalidomide and dexamethasone alone. Response rates doubled in patients receiving the triplet combination compared with those receiving pomalidomide and dexamethasone alone, with very good partial responses or better seen in 20% of patients treated with elotuzumab (n = 12) and 8.8% of patients who were not (n = 5).
Serious adverse reactions were reported in 22% of patients treated with elotuzumab plus pomalidomide and dexamethasone and in 15% of patients treated with pomalidomide and dexamethasone. Discontinuation of any component of the treatment regimen due to adverse reactions occurred in 5.0% of patients in the triple therapy arm, compared with 1.8% of patients in the control arm.
