FDA Approves Elotuzumab-Based Triplet Regimen for Myeloma

The FDA approved the combination of elotuzumab plus pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

The agency’s decision was based on results from the randomized, phase II ELOQUENT-3 trial, which compared the elotuzumab combination with pomalidomide and dexamethasone alone. After a median follow-up of 10.25 months (range not reported), the triplet therapy doubled both median progression-free survival (PFS; 10.25 months vs. 4.67 months; p=0.008) and overall response rate (53.3% vs. 26.3%; p=0.003). This included a higher rate of very good partial responses or better in the elotuzumab group (20% vs. 9%; p value not provided).

Serious adverse events (AEs) were reported in 22 percent of patients treated with the triplet therapy and in 15 percent of patients in the control arm. AEs led to treatment discontinuation of any drug in 5 percent of patients in the elotuzumab arm and 1.8 percent in the pomalidomide-dexamethasone arm.

Elotuzumab, an anti-SLAMF7 antibody, was previously approved in combination with lenalidomide and dexamethasone for the treatment of patients with MM who have received one to three prior therapies.

Source: Bristol-Myers Squibb press release, November 6, 2018; FDA approval letter, November 6, 2018.