U.S. Food and Drug Administration Approves Empliciti® Plus Pomalidomide to Treat Certain Patients with Relapsed or Refractory Multiple Myeloma


The U.S. Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone (EPd) for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1

About Empliciti

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 lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies.

 

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

References

  1. Empliciti Prescribing Information. EmplicitiS. Product Information. Last Updated: November 2018. Princeton, NJ: Bristol-Myers Squibb Company.
  2. 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.
  3. 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.

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