by Dr. C.H. Weaver M.D. updated 3/2019
Empliciti is a precision cancer medicine -monoclonal antibody that is targeted against the Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7) which is found on myeloma cells and has been demonstrated to improve the treatment outcomes of individuals with multiple myeloma.
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.
The initial FDA approval was based on the Phase 3 ELOQUENT-2 clinical trial in which Empliciti plus Revlimid (lenalidomide) demonstrated effectiveness in treating patients with relapsed/refractory multiple myeloma compared to patients treated with Revlimid alone.(1,2)
Empliciti in Recurrent or Relapsed Multiple Myeloma
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.
Empliciti® Plus Pomalidomide Approved to Treat Certain Patients with Relapsed or Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) approved Empliciti for use in combination with Pomalyst (pomalidomide) and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including Revlimid and a proteasome inhibitor in November 2018 based on results of the Eloauent-3 clinical trial.(3,4,5)
About The ELOQUENT-3 Clinical Trial
ELOQUENT-3 was a Phase 2 clinical study evaluating the addition of Empliciti to pomalidomide and dexamethasone by comparing it to pomalidomide and dexamethasone in 117 patients with multiple myeloma who received two or more prior therapies and were either refractory or relapsed and refractory to Revlimid and a proteasome inhibitor.1,3,4 The key trial results leading to FDA approval:
- EPd delayed the risk of disease progression by 46% from from 4.7 to 10.2 months.
- Response rates doubled in patients receiving EPd compared with patients receiving Pd alone.
- Serious adverse reactions were reported in 22% of patients treated with EPd and in 15% of patients treated with Pd.1
- 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
- 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.
- Ravi P, Kumar S, Cerhan J, et al. Defining cure in multiple myeloma: a comparative study of outcomes of young individuals with myeloma and curable hematologic malignancies. Blood Cancer J. 2018;8-26.
- ClinicalTrials.gov. An Investigational Immuno-Therapy Trial of Pomalidomide and Low-Dose Dexamethasone With or Without Elotuzumab to Treat Refractory and Relapsed and Refractory Multiple Myeloma (ELOQUENT-3). https://clinicaltrials.gov/ct2/show/NCT02654132?term=NCT02654132&rank=1. Accessed September 25, 2018.
- Dimopoulos M, Dytfeld D, Grosicki S, et al. Elotuzumab plus Pomalidomide/Dexamethasone (EPD) VS PD for the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 2, Randomized Open-Label ELOQUENT-3 Study. (Slides from Oral Presentation) Presentation: The 23rd Congress of The European Hematology Association; June 2018; Stockholm, Sweden.