On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor.
In ELOQUENT-3, a randomized, open-label, phase II trial, elotuzumab plus pomalidomide and dexamethasone demonstrated benefit in patients with relapsed or refractory multiple myeloma, doubling both median progression-free survival and overall response rate vs pomalidomide and dexamethasone.
Following Priority Review by the FDA, elotuzumab plus pomalidomide and dexamethasone is the first triplet combination to be approved based on a randomized clinical trial using pomalidomide and dexamethasone as a comparator.
About ELOQUENT-3
ELOQUENT-3 was a randomized, open-label phase II study evaluating the addition of elotuzumab to pomalidomide and dexamethasone vs pomalidomide and dexamethasone in 117 patients with multiple myeloma who received two or more prior therapies and were either refractory or relapsed and refractory to lenalidomide and a proteasome inhibitor. Patients were randomly assigned 1:1 to receive either elotuzumab plus pomalidomide and dexamethasone (n = 60) or pomalidomide and dexamethasone (n = 57) in 28-day cycles until disease progression or unacceptable toxicity.
The approved dose of elotuzumab when used in combination with pomalidomide and dexamethasone 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.
The primary efficacy outcome measure of the trial was progression-free survival as determined by the investigator. The secondary efficacy outcome measure of overall response rate included complete, stringent-complete, very good partial, and partial response rates as determined by investigator assessment, based on the International Myeloma Working Group criteria.
Results from the ELOQUENT-3 trial, which were presented at the 23rd Congress of the European Hematology Association in June 2018 (Abstract LB2606) in June 2018, include:
Elotuzumab with pomalidomide and dexamethasone is associated with warnings and precautions related to infusion reactions, infections, secondary primary malignancies, hepatotoxicity, interference with determination of complete response, pregnancy, and reproductive potential.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.