FDA Accepts sBLA for Elotuzumab Plus Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) for elotuzumab (Empliciti) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor. The FDA granted the application priority review with an action date of December 27, 2018.

The application is based on data from ELOQUENT-3, a randomized phase II study evaluating the addition of elotuzumab to pomalidomide and low-dose dexamethasone in patients with relapsed or refractory multiple myeloma. Data from this study were presented at the 23rd Congress of the European Hematology Association in June.

More About ELOQUENT-3

The phase II ELOQUENT-3 trial randomized 117 patients with relapsed or refractory 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 randomized 1:1 to receive either elotuzumab, pomalidomide, and low-dose dexamethasone (n = 60) or pomalidomide and low-dose dexamethasone (n = 57) in 28-day cycles until disease progression or unacceptable toxicity.

Patients in both arms received 4 mg of pomalidomide for days 1 to 21 of each cycle and the weekly equivalent of 40 mg or 20 mg of dexamethasone for patients ≤ 75 years or > 75 years, respectively. In the three-drug arm, elotuzumab was administered at the dose of 10 mg/kg intravenously weekly for the first 2 cycles and 20 mg/kg monthly starting from cycle 3.

Patients randomized to elotuzumab, pomalidomide, and low-dose dexamethasone experienced a 46% reduction in risk of disease progression (hazard ratio [HR] = 0.54, 95% confidence interval [CI] = 0.34–0.86; P = .0078) compared with patients randomized to pomalidome and low-dose dexamethasone alone, with a median progression-free survival (the study’s primary endpoint) of 10.3 months (95% CI = 5.6 months to not estimable) compared with 4.7 months (95% CI = 2.8–7.2) in pomalidomide/low-dose dexamethasone recipients. The progression-free survival benefit experienced among patients randomized to the elotuzumab-containing regimen was consistent among patients who had received two to three prior lines of therapy (HR = 0.55, 95% CI = 0.31–0.98) and four or more prior lines of therapy (HR = 0.51, 95% CI = 0.24–1.08). The safety profile for elotuzumab, pomalidomide, and low-dose dexamethasone was consistent with prior findings for elotuzumab and pomalidomide regimens.

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®.




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