FDA Grants Priority Review to Empliciti Combo Therapy for Relapsed or Refractory Myeloma

FDA Grants Priority Review to Empliciti Combo Therapy for Relapsed or Refractory Myeloma

The U.S. Food and Drug Administration granted priority review to Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) combined with Pomalyst (pomalidomide) and low-dose dexamethasone as a treatment for patients with relapsed or treatment-resistant multiple myeloma.

The application covers patients whose disease has progressed despite treatment with at least two therapies, including Revlimid (lenalidomide) and a proteasome inhibitor — such as Velcade (bortezomib), Kyprolis (carfilzomib), or Ninlaro (ixazomib).

A decision from the FDA on the application is expected by Dec. 27.

The sBLA is based on positive data from the Phase 2 ELOQUENT-3 trial (NCT02654132). The findings, “Elotuzumab plus pomalidomide/dexamethasone (EPD) vs PD for treatment of relapsed/refractory multiple myeloma (RRMM): results from the Phase 2, randomized open-label ELOQUENT-3 study,” were recently presented at the 23rd European Hematology Association Congress in Stockholm.

In the study, researchers assessed if Empliciti combined with Pomalyst and low-dose dexamethasone was more efficient at delaying disease progression or death in relapsed/refractory multiple myeloma patients than Pomalyst and dexamethasone alone.

Empliciti is an antibody that specifically targets and binds to a molecule called signaling lymphocyte activation molecule family member 7 (SLAMF7). This molecule is present on both the surface of myeloma cells and natural killer cells (NK), a type of immune cell that helps the body destroy tumors.

This investigational compound works in two complementary ways: By binding to NK cells, Empliciti activates a patient’s immune system, and by binding to myeloma cells, it tags them for NK cell-mediated destruction.

Trial participants included 117 patients who had failed at least two prior lines of therapy, including Revlimid and a proteasome inhibitor.

Results showed that patients treated with the triple combination lived longer without disease progression (10.3 months versus 4.7 months in the control group), and the treatment had an acceptable safety profile. The overall response rate was also better in the triple combination — 53% versus 26%.

Overall, the trial’s results support the addition of Empliciti to Pomalyst and dexamethasone for advanced myeloma patients who failed to respond to prior treatment with Revlimid and a proteasome inhibitor.

“This file acceptance is an important step in BMS’s ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” Jeffrey Jackson, PhD, hematology development lead at Bristol-Myers Squibb, said in a press release.

“Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with RRMM whose disease progressed on previous therapies as quickly as possible,” he said.

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