FDA Approves Triplet Regimen for Multiple Myeloma

The U.S. Food and Drug Administration approved elotuzumab in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM). The approval is based on results from the randomized, phase II ELOQUENT-3 trial, in which the triplet therapy doubled both median progression-free survival (PFS) and overall response rate compared with pomalidomide and dexamethasone alone.

The triplet therapy reduced the risk of disease progression by 46 percent (hazard ratio = 0.54; 95% CI 0.34-0.86; p=0.008). After a minimum follow-up of 9.1 months, the median PFS was 10.25 months (95% CI 5.59 to non-estimable) for the elotuzumab-based regimen, versus 4.67 months (95% CI 2.83-7.16) for pomalidomide and dexamethasone alone.

Response rates also were significantly higher in patients receiving elotuzumab in combination with pomalidomide and dexamethasone (53.3%; n=32/60 [95% CI 40.0-66.3]) compared with patients receiving pomalidomide and dexamethasone alone (26.3%; n=15/57 [95% CI 15.5-39.7]; p=0.003).

Serious adverse reactions were reported in 22 percent of patients treated with the triplet therapy and in 15 percent of patients in the control arm.

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

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