Trial of three-agent combination for multiple myeloma misses endpoint
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A randomized phase 3 trial designed to evaluate the addition of elotuzumab to lenalidomide and low-dose dexamethasone for a subset of patients with multiple myeloma failed to meet its primary endpoint, according to the agent’s manufacturer.
The open-label ELOQUENT-1 trial included patients with newly diagnosed, previously untreated multiple myeloma who were ineligible for transplant.
Researchers assigned patients to lenalidomide (Revlimid, Celgene) and low-dose dexamethasone with or without elotuzumab (Empliciti; Bristol-Myers Squibb, AbbVie), a signaling lymphocyte activation molecule (SLAMF7)-directed immunostimulatory antibody.
Treatment in both groups continued until disease progression.
Results showed no significant improvement in PFS — the study’s primary endpoint — with the addition of elotuzumab.
The elotuzumab-lenalidomide-dexamethasone combination exhibited a safety profile consistent with prior studies.
Complete results will be evaluated and submitted for presentation at a medical meeting.
The FDA previously approved the combination of elotuzumab, lenalidomide and dexamethasone for treatment of patients with multiple myeloma who received one to three prior therapies.
“[Although] we are disappointed that the ELOQUENT-1 trial did not meet its primary endpoint in these previously untreated, transplant-ineligible patients, the [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,” Noah Berkowitz, MD, PhD, senior vice president for global clinical development in hematology, said in a Bristol-Myers Squibb-issued press release.