Primary results of ELOQUENT-1 Study of Empliciti + Revlimid + dexamethasone in patients with newly diagnosed, untreated multiple myeloma. BMS

Bristol Myers Squibb Companyy announced topline results from ELOQUENT-1, a Phase III, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. Both treatments were administered continuously until disease progression. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. The safety profile of ERd was generally consistent with the known profile of Empliciti plus Revlimid and dexamethasone. The company will complete a full evaluation of the ELOQUENT-1 data and work with investigators to present the results at a future medical meeting. “While we are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant ineligible patients, the Empliciti, Revlimid and dexamethasone combination remains a standard treatment for patients with relapsed/refractory multiple myeloma, providing the potential for improved survival in this population of patients who are in need of additional treatment options,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. Comment: Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.