The European Commission approved elotuzumab in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma (MM) in patients who have received at least one prior therapy.
The approval was based on the results of the randomized, open-label, phase III ELOQUENT-2 study that evaluated elotuzumab in combination with lenalidomide and dexamethasone (ERd) versus lenalidomide and dexamethasone alone (Rd) in 646 patients. At three years, those treated with ERd had a higher rate of progression-free survival than those treated with Rd (23% vs. 15%). Patients in the ERd-treated group also experienced a 32 percent reduction in the risk of disease progression or death, compared with patients in the Rd-treated group (hazard ratio [HR] = 0.68; 97.6% CI 0.55-0.85; p=0.0001). ERd resulted in a significant overall response rate compared with Rd: 78.5 percent (95 % CI 73.6-82.9; p=0.0002) versus 65.5 percent (95% CI 60.1-70.7).
The most common any-grade adverse events reported for ERd and Rd included diarrhea (59.2% vs. 49.3%), pyrexia (43% vs. 27%), fatigue (40% vs. 34.7%), cough (33.2% vs. 20.3%), nasopharyngitis (29.5% vs. 27.7%), upper respiratory tract infection (25.2% vs. 22.7%), lymphopenia (17.6% vs. 13.6%), headache (17.2% vs. 9.6%), pneumonia (15.6% vs. 12.9%), and herpes zoster (10% vs. 5.7%).
The ELOQUENT-2 study is ongoing.
Source: Bristol Myers-Squibb and AbbVie press release, May 11, 2016.