Elotuzumab Triplet Granted Priority Review by FDA for Myeloma

A supplemental biologics license application (sBLA) for elotuzumab (Empliciti) has been granted a priority review by the FDA for use in combination with pomalidomide (Pomalyst) and low-dose dexamethasone (EPd) as a treatment for patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor (PI).

The application is based on data from the phase II ELOQUENT-3 trial. Results from the study showed the addition of elotuzumab to pomalidomide and dexamethasone reduced the risk of disease progression or death by 46% compared with pomalidomide and dexamethasone alone for patients with relapsed/refractory multiple myeloma. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a decision on the sBLA by December 27, 2018.

In the ELOQUENT-3 trial, the median progression-free survival (PFS) was 10.3 months (95% CI, 5.6–not estimable) with the elotuzumab combination compared with 4.7 months (95% CI, 2.8-7.2) with pomalidomide plus dexamethasone (HR, 0.54; 95% CI, 0.34-0.86; = .0078). The PFS benefit associated with EPd was similar, regardless of whether patients had received 2 to 3 prior lines of treatment (HR 0.55; 95% CI, 0.31-0.98), or ≥4 lines of treatment (HR 0.51; CI 95%, 0.24-1.08).

The objective response rate (ORR) was 53% (95% CI, 40%-66%) with elotuzumab compared with 26% (95% CI, 16%-40%) in the control arm (odds ratio, 3.25; 95% CI, 1.49-7.11; P = .0029). The rate of very good partial response or better was 20% versus 9%, with and without elotuzumab, respectively.

“This file acceptance is an important step in BMS’s ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” said Jeffrey Jackson, PhD, hematology development lead at Bristol-Myers Squibb, which is co-developing elotuzumab with AbbVie.

“Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with relapsed/refractory multiple myeloma whose disease progressed on previous therapies as quickly as possible,” added Jackson.

The phase II ELOQUENT-3 study enrolled 117 patients with relapsed/refractory multiple myeloma who were randomized to the elotuzumab combination (n = 60) or pomalidomide and dexamethasone alone (n = 57). Elotuzumab was administered at 10 mg/kg intravenously each week during cycles 1 and 2 and at 20 mg/kg every 4 weeks thereafter. Pomalidomide was given at 4 mg orally on days 1 to 21 of each cycle plus dexamethasone weekly at 40 mg for patients ≤75 years of age or 20 mg for those >75 years.
Read more: https://www.targetedonc.com/news/elotuzumab-triplet-granted-priority-review-by-fda-for-myeloma