US regulators have expanded the treatment scope of Bristol-Myers Squibb’s Empliciti allowing its use plus pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
The approval is based on the ELOQUENT-3 clinical trial, which showed that treatment with EPd doubled both progression-free survival and overall response rate compared to pomalidomide and dexamethasone.
According to the data, EPd cut the risk of disease progression by 46%, demonstrating a median PFS of 10.25 months versus 4.67 months for Pd alone after a minimum follow-up of 9.1 months.
Response rates doubled in patients receiving EPd (53.3) compared with patients receiving Pd alone (26.3%) with very good partial responses or better seen in 20% of EPd-treated patients and 8.8% of Pd-treated patients, the firm noted.
“Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,” said Paul Richardson, clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.
“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. Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients.”
Empliciti (elotuzumab) is already indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies.