FDA Approves Empliciti Combination for Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration has approved Bristol-Myers Squibb‘s Empliciti (elotuzumab), in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, as a treatment for patients with relapsed or treatment-resistant multiple myeloma.

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

“Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease progression, giving health care professionals an effective new tool to tackle this relentless cancer,” Joseph E. Eid, MD, senior vice president and head of medical at Bristol-Myers Squibb, said in a press release.

“Today’s approval reinforces the importance of Immuno-Oncology in blood cancers and expands the role of Empliciti to address the needs of relapsed or refractory multiple myeloma patients,” he added.

The approval was based on data from the randomized Phase 2 ELOQUENT-3 clinical trial (NCT02654132) that assessed the triple combination versus Pomalyst and dexamethasone alone in 117 patients with relapsed or refractory multiple myeloma.

Results showed that patients treated with the combination lived more than twice as long without disease progression as the control group — 10.3 months versus 4.7 months.

In addition, the overall response rate of patients receiving the triple combination doubled that of the control group — 53% versus 26%.

The study, conducted by Bristol-Myers Squibb, in collaboration with Celgene and AbbVie — which co-develops Empliciti — also showed that the triple therapy had an acceptable safety profile.

Serious adverse events were reported in 22% of patients treated with the triple combination and 15% of controls. The percentage of patients who stopped treatment due to adverse reactions was 5% in the triple combination group and 1.8% in the control group.

“Despite remarkable recent innovations with novel therapies for the treatment of multiple myeloma, many patients still face poor outcomes, and particularly in the relapsed and relapsed, refractory setting,” said Paul Richardson, MD, clinical program leader and director of clinical research of the Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute.

“This new regimen of elotuzumab combined with pomalidomide and dexamethasone not only extended the time to disease progression versus a standard of care but also doubled the response rate in some patients whose prior treatments had failed them. Thus to be able to offer an alternative with a meaningful clinical benefit is an important and significant milestone for our patients,” Lipper added.

Multiple myeloma, estimated to affect almost 31,000 people in the United States in 2018 alone, can lead to multiple relapses where the cancer returns after a remission period.

“Relapse can be overwhelming and extremely challenging for multiple myeloma patients, particularly after they have already tried several therapies,” said Paul Giusti, president and CEO of the Multiple Myeloma Research Foundation. “Empliciti, in combination with pomalidomide and dexamethasone, is an exciting new option for patients with relapsed or refractory myeloma.”

In August, the triple combination received priority review from the FDA as a treatment for the same patient population.

Empliciti is an antibody that targets and binds to the SLAMF7 protein, found at the surface of myeloma cells and a type of immune cell called natural killer cells, which help destroy tumors.

The therapy has a dual mechanism of action: It binds to natural killer cells and activates the immune system against tumor cells, as well as binding to myeloma cells and tagging them for natural killer cell-mediated destruction.

The triple combination is currently under review for approval by the European Medicines Agency.