The European Commission (EC) has approved elotuzumab plus pomalidomide and low-dose dexamethasone (EPd) to treat relapsed and refractory multiple myeloma in adult patients who have received at least two therapies, including lenalidomide and a proteasome inhibitor (PI), and whose disease has progressed during their most recent therapy.
The EC’s approval is based on results from the phase II ELOQUENT-3 trial, which randomized 117 patients with relapsed and refractory myeloma to receive either EPd or Pd alone. After a median follow-up period of 9.1 months, treatment with EPd doubled patients’ median progression-free survival (10.25 months vs. 4.67 months) and overall response rates (53.3% vs. 26.3%) compared with Pd alone.
“The approval of this 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, MD, professor and chairman of the Department of Clinical Therapeutics at National and Kapodistrian University of Athens, and principal investigator of the ELOQUENT-3 trial.
Treatment-related adverse events (AEs) were similar between the EPd and Pd groups, the researchers added. The most common grade 3-4 hematologic AEs in the EPd arm were neutropenia (13%) and anemia (10%).
In November 2018, the U.S. Food and Drug Administration approved EPd for the same indications.