The US Food and Drug Administration (FDA) on September 1, 2015, accepted for Priority Review the Biologics License Application for elotuzumab (Empliciti) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.
Patients with multiple myeloma who have suffered relapse may soon have a new option. The US Food and Drug Administration (FDA) on September 1, 2015, accepted for Priority Review the Biologics License Application for elotuzumab (Empliciti) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.
An investigational signaling lymphocyte activation molecule F7 (SLAMF7)-directed immunostimulatory antibody, elotuzumab, was previously granted Breakthrough Therapy Designation by the FDA and the European Medicines Agency (EMA) which also recently granted it accelerated assessment.
“Bristol-Myers Squibb is delighted by the approach both agencies have taken to review the Empliciti applications as it underscores the unmet medical need in the treatment of multiple myeloma and the role Immuno-Oncology may play,” said Michael Giordano, MD, who is the senior vice president and Head of Oncology Development at Bristol-Myers Squibb, in a press release. “The acceptance of our applications by the FDA and EMA brings Bristol-Myers Squibb’s Immuno-Oncology science a step closer to helping patients with hematologic malignancies.”1
Long-term survival and a positive quality of life have remained elusive for many multiple myeloma patients with advanced disease. Now, it is hoped that this investigational immunostimulatory antibody targeted against SLAMF7, a cell-surface glycoprotein, will be able to improve outcomes. SLAMF7 is highly and uniformly expressed on myeloma cells and natural killer (NK) cells. However, it is not detected on normal solid tissues or on hematopoietic stem cells.
The filing acceptance for this new agent comes on the heels of positive data from the ELOQUENT-2 trial, a phase III, randomized, open-label study, which evaluated elotuzumab in combination with lenalidomide (Revlimid) and dexamethasone versus lenalidomide and dexamethasone alone. The results of this trial, which were published in The New England Journal of Medicine on June 2, 2015, showed that patients who received a combination of elotuzumab, lenalidomide, and dexamethasone had a significant relative reduction of 30% in the risk of disease progression or death.2
The phase III trial included 321 patients and the researchers found that the rate of progression-free survival (PFS) at 1 year in the elotuzumab group was 68% versus 57% in the control group. The rates were 41% versus 27%, respectively for placebo at 2 years. Additionally, the filing was supported by data from study CA204-009, a phase II, randomized, open-label study which evaluated elotuzumab with bortezomib (Velcade) and dexamethasone versus bortezomib and dexamethasone alone.
Despite advances in multiple myeloma treatment over the last decade, it remains a largely incurable disease with only 45% of patients surviving 5 years after diagnosis. Following relapse, less than 20% of patients are alive after 5 years. It is estimated that annually more than 114,200 new cases of multiple myeloma are diagnosed globally.