Bristol-Myers Squibb announced topline results from ELOQUENT-1, a Phase 3 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. Final data showed the addition of Empliciti did not result in a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint. The company will fully analyze the ELOQUENT-1 data and work with investigators to present the results at a future medical meeting.
ELOQUENT-1 was a randomized, open-label trial and enrolled approximately 750 patients with newly diagnosed, previously untreated multiple myeloma. The purpose of the study was to determine whether the addition of Empliciti to Revlimid and low-dose dexamethasone would improve PFS, the study’s primary endpoint. Secondary endpoints included objective response rate and overall survival. The safety profile of ERd was generally consistent with the known profile of Empliciti plus Revlimid and dexamethasone.
Bristol Myers Squibb and AbbVie are co-developing Empliciti, with Bristol Myers Squibb solely responsible for commercial activities.
About Empliciti (elotuzumab)
Empliciti is an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein. SLAMF7 is expressed on myeloma cells independent of cytogenetic abnormalities. SLAMF7 also is expressed on Natural Killer cells, plasma cells and at lower levels on specific immune cell subsets of differentiated cells within the hematopoietic lineage. Empliciti has a dual mechanism-of-action. It directly activates the immune system through Natural Killer cells via the SLAMF7 pathway. Empliciti also targets SLAMF7 on myeloma cells, tagging these malignant cells for Natural Killer cell-mediated destruction via antibody-dependent cellular toxicity.
Empliciti was initially approved by the FDA in 2015 in combination with Revlimid and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. In 2018, Empliciti was approved by the FDA in a new combination, with Pomalyst/Imnovid (pomalidomide) and dexamethasone (EPd), for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The ELd and EPd indications were subsequently approved by the European Commission in 2016 and 2019, respectively.
About Multiple Myeloma
Multiple myeloma is a life-threatening rare blood cancer that arises from the plasma cells, a type of white blood cell that is made in the bone marrow. These plasma cells become abnormal, multiply and release a type of antibody known as a paraprotein, which causes symptoms of the disease, including bone pain, frequent or recurring infections and fatigue, a symptom of anemia. These malignant plasma cells have the potential to affect many bones in the body and can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count. The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission. Nearly 230,000 people around the world live with multiple myeloma, with approximately 114,000 new cases diagnosed globally each year.