Four-year follow-up data from the Phase 3 ELOQUENT-2 clinical trial in which Empliciti (elotuzumab) plus Revlimid (lenalidomide) continued to demonstrate effectiveness in patients with relapsed/refractory multiple myeloma compared to patients treated with Revlimid alone were recently presented in an oral session today during the 22nd Congress of the European Hematology Association in Madrid, Spain. Combination therapy demonstrated a sustained reduction in the risk of myeloma progression or death and an improvement in progression-free and overall survival compared to revlimid alone.
Multiple myeloma is a type of blood cancer that affects certain immune cells called plasma cells. Healthy plasma cells produce proteins called antibodies that are an important part of the immune system’s defense for fighting bacteria and viruses.
Cancerous plasma cells tend to replicate at a fast pace, crowding out other healthy immune cells, as well as producing malfunctioning antibodies. These antibodies tend to cause damage to the kidneys, in addition to reducing the immune system’s ability to efficiently fight infection.
Empliciti is a monoclonal antibody that is targeted against the Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7). Empliciti binds to SLAMF7, which is found on myeloma cells and results in the cells destruction through various processes, including stimulation of the immune system to fight the cancer cells.
The initial approval of Empliciti was based on the early findings of the ELOQUENT-2 clinical trial that included 646 patients with multiple myeloma who had received one to three prior therapies for their disease. One group of patients was treated with Empliciti plus lenalidomide/dexamethasone, while the other group was treated with lenalidomide/dexamethasone only.
- The median duration of progression-free survival (survival without progression of cancer) was 19.4 months for patients treated with Empliciti/lenalidomide/dexamethasone, compared with 14.9 months for those treated with lenalidomide/dexamethasone only.
- Anti-cancer responses (partial or complete eradication of myeloma cells) occurred in 78.5% of patients treated with Empliciti combination, compared with 65.5% of patients treated with lenalidomide/dexamethasone.
- The most common side effects that occurred more frequently among those treated with Empliciti included fatigue, diarrhea, fever, constipation and cough.
After four-years follow up, Empliciti combined with Revlimid therapy continued to demonstrate a clinically meaningful and sustained relative improvement of 50% in progression-free survival (PFS) rate of 21% compared to 14% with Revlimid alone. Most importantly, Empliciti in combination with Revlimid also demonstrated an improved overall survival benefit of 48 months versus 40 months for Revlimid.
These extended four-year follow-up data demonstrated that adding Empliciti to Revlimid yielded clinically relevant improvements and reductions in the risk of disease progression or death for patients with relapsed/refractory multiple myeloma.
Reference: United States Food and Drug Administration (FDA). FDA news release. FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma. Accessed November 30, 2015. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474684.htm.
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