Elotuzumab (Empliciti) with pomalidomide and dexamethasone (Pd) is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator.
Officials with the FDA have approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of certain patients with relapsed or refractory multiple myeloma, according to a press release.1
EPd is the first triplet combination to be approved based on a randomized clinical trial using Pd as a comparator, according to Bristol-Myers Squibb.1
The approval is based on data from the ELOQUENT-3 phase 2 trial which evaluated elotuzumab plus pomalidomide and dexamethasone (Pd) versus Pd in 117 patients with relapsed or refractory multiple myeloma who received 2 or more prior therapies, including lenalidomide and a proteasome inhibitor. According to the results, EPd doubled both median progression-free survival (PFS) and overall response rate (ORR) versus Pd.1
The approved dose of EPd is 10 mg/kg administered intravenously every week for the first two 28-day cycles, followed by 20 mg/kg every 4 weeks until disease progression or unacceptable toxicity.1
According to the release, key data from the trial include1:
“This new regimen of elotuzumab combined with pomalidomide 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,” Paul Richardson, MD, clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, said in a statement.1 “Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients.”
Elotuzumab is also indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received 1 to 3 prior therapies.2