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FDA approves triplet regimen for relapsed, refractory myeloma
The FDA approved elotuzumab plus pomalidomide and dexamethasone for treatment of adults with relapsed or refractory multiple myeloma.
The triplet regimen of elotuzumab (Empliciti; Bristol-Myers Squibb, AbbVie), pomalidomide (Pomalyst, Celgene) and dexamethasone is indicated for patients who received at least two prior therapies, including lenalidomide (Revlimid, Celgene) and a proteasome inhibitor.
“Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,” Joseph E. Eid, MD, senior vice president and head of medical at Bristol-Myers Squibb, said in a company-issued press release. “Today’s approval reinforces the importance of immuno-oncology in blood cancers and expands the role of Empliciti to address the needs of [patients with] relapsed or refractory multiple myeloma.”
Elotuzumab — an immunostimulatory antibody that targets SLAMF7, a cell-surface glycoprotein — is administered via IV injection.
The agent already is approved for use in combination with lenalidomide and dexamethasone for adults with myeloma who received one to three prior therapies.
The FDA based the new indication on results of the randomized phase 2 ELOQUENT-3 trial, which included 117 patients with myeloma who received two or more prior therapies, including lenalidomide and a proteasome inhibitor.
Researchers randomly assigned patients 1:1 to pomalidomide and dexamethasone with elotuzumab (n = 60) or without elotuzumab (57). Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.
PFS served as the primary efficacy outcome measure. Overall response rate served as a secondary efficacy outcome.
Minimum follow-up was 9.1 months.
Results showed the triplet doubled median PFS (10.25 months vs. 4.67 months; HR = 0.54; 95% CI, 0.34-0.86) and ORR (53% vs. 26.3%; P = .0029) compared with pomalidomide and dexamethasone alone.
Serious adverse reactions occurred among 22% of patients assigned the triplet and 15% of patients assigned pomalidomide/dexamethasone alone; 5% of patients assigned the triplet and 1.8% of patients in the control arm discontinued treatment due to adverse reactions.
The most common serious adverse events in the trial were pneumonia (13% for the triplet vs. 11% for control) and respiratory tract infection (7% vs. 3.5%).
Adverse reactions that occurred among at least 10% of patients assigned the triplet included constipation (22% for triplet vs. 11% for control), hyperglycemia (20% vs. 15%), pneumonia (18% vs. 13%), diarrhea (18% vs. 9%), respiratory tract infection (17% vs. 9%), bone pain (15% vs. 9%), dyspnea (15% vs. 7%), muscle spasms (13% vs. 5%), edema peripheral (13% vs. 7%) and lymphopenia (10% vs. 1.8%).
“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,” Paul Richardson, MD, clinical program leader and director of clinical research at Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute and a HemOnc Today Editorial Board member, said in the release. “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.”