European Commission (EC) has approved elotuzumab –marketed under the brand Empliciti by Bristol-Myers Squibb (BMS)– plus pomalidomide and low-dose dexamethasone (EPd) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI), and have demonstrated disease progression on the last therapy. This approval is based on data from the ELOQUENT-3 trial in which EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) among patients with relapsed and refractory myeloma versus pomalidomide and low-dose dexamethasone (Pd) alone.
EPd is the first triplet combination approved in Europe based on a randomized clinical trial using the standard of care, Pd, as a comparator. Results from ELOQUENT-3 demonstrated that the addition of elotuzumab to Pd can significantly prolong survival without disease progression among heavily pretreated myeloma patients regardless of the number of prior therapies received. The study’s primary endpoint was the primary endpoint and it was 10.25 months among patients randomized to EPd compared with 4.67 months among patients treated with Pd alone, indicating a 46% reduction in risk of disease progression after a minimum follow-up of 9.1 months. A secondary endpoint of the study, overall response rate (ORR), was 53.3% compared with 26.3% among patients receiving EPd or Pd, respectively.
“The approval of this elotuzumab-based triplet combination in the relapsed and refractory setting gives patients, and their doctors, a treatment alternative shown to have the potential to offer patients more time living without disease progression, coupled with a tolerable safety profile,” said Meletios A. Dimopoulos, M.D., professor and chairman of the Department of Clinical Therapeutics at National and Kapodistrian University of Athens.
Elotuzumab was initially approved by the the Food and Drug Administration (FDA) in 2015 in combination with lenalidomide and dexamethasone (ELd) for the treatment of patients with multiple myeloma who have received one to three prior therapies. In 2018, this drug was approved by the FDA in a new combination, with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI. The ELd and EPd indications were subsequently approved by the EC in 2016 and 2019, respectively.