Bristol-Myers' ELOQUENT-3 trial meets primary endpoint
Bristol-Myers Squibb announced that the ELOQUENT-3 trial, an international Phase 2 study evaluating the addition of Empliciti to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma, achieved its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival for patients treated with EPd compared with pomalidomide and dexamethasone alone. ELOQUENT-3 is the only randomized, active-controlled trial to investigate a pomalidomide-based triplet combination in patients with RRMM who received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Twice as many patients randomized to EPd responded to therapy compared to patients randomized to Pd alone. Patients randomized to EPd demonstrated an overall response rate of 53%, compared with 26% among patients randomized to Pd. Time to first response was comparable for patients receiving EPd and Pd at 1.95 and 1.91 months, respectively. Median duration of response had not been reached among patients randomized to EPd at time of analysis. Overall survival, a secondary endpoint, although not mature at this time, showed a positive trend favoring EPd over Pd alone. Treatment-related Grade 3-4 adverse events were comparable between EPd and Pd groups.