The European Commission (EC) has approved Bristol-Myers Squibb’s
Empliciti (elotuzumab) in combination with 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.
The indication is for patients who have demonstrated disease progression on the last therapy, including lenalidomide and a proteasome inhibitor (PI).
The company has announced that the EC approval of the triple combo 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 the disease, compared to pomalidomide and low-dose dexamethasone (Pd) alone.
EPd is the first triplet combination approved in Europe based on a randomised clinical trial using the standard of care, Pd, as a comparator. Results from the trial found that the PFS when treated with Empliciti was 10.25 months compared to 4.67 months for those on placebo, indicating a 46% reduction in risk of disease progression.
Multiple myeloma is a “frequently recurring disease and the chance it will return after initial treatment is a heavy burden for patients to carry,” said Fouad Namouni, head Oncology Development, Bristol-Myers Squibb.
He continued, “We are proud that the European Commission has again recognised the role of Empliciti in helping European patients with multiple myeloma by approving a second Empliciti-based regimen in the relapsed and refractory setting.”
The approval “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,” explained Meletios A. Dimopoulos, professor and chairman of the Department of Clinical Therapeutics at National and Kapodistrian University of Athens.
The US Food and Drug Administration (FDA) already approved the drug, which is co-developed by Bristol-Myers Squibb and AbbVie, in this indication in November 2018.