Addition of Empliciti to Combination Regimen Continues to Show Benefit in Previously Treated Multiple Myeloma

Long-term follow-up shows that treatment with Empliciti plus pomalidomide and dexamethasone continues to significantly increase survival rates in patients with relapsed or refractory multiple myeloma, a persistent cancer affecting white blood cells that may be resistant to treatment.

Adding Empliciti (elotuzumab) to pomalidomide and dexamethasone may improve survival in patients with relapsed or refractory multiple myeloma compared with pomalidomide and dexamethasone alone, according to results from a recent trial.

“(Empliciti, pomalidomide and dexamethasone) demonstrated a statistically significant reduction in the risk of death versus (pomalidomide and dexamethasone) in patients with (relapsed/refractory multiple myeloma) previously treated with lenalidomide and a (proteasome inhibitor), and a gain in median (overall survival) of one year,” the researchers wrote in the study published in the Journal of Clinical Oncology. “ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and (pomalidomide and dexamethasone) in this setting to show both (progression-free survival) and (overall survival) benefits.”

Researchers enrolled 117 patients with multiple myeloma who were previously treated with two or more lines of therapy including Revlimid (lenalidomide) and proteasome inhibitors. Multiple myeloma was classified as either refractory (cancer that does not respond to or improve with treatment) or both relapsed (cancer that progressed within six months after treatment was ended with a greater than partial response) and refractory.

Empliciti is a monoclonal antibody, meaning it activates natural killer cells in the blood as well as helping those activated natural killer cells identify and attack the cancerous myeloma cells.

Of the patients in the study, 60 were treated with Empliciti, pomalidomide and dexamethasone and 57 were treated with pomalidomide and dexamethasone alone.

Throughout the study, 61.7% of patients treated with the triplet regimen died compared with 74.5% treated with combination therapy. Of note, the most common cause of death was disease progression (41.7% and 49.1%, respectively).

Patients assigned the triplet regimen had an improved overall survival (the time from treatment initiation when a patient is still alive) compared with those assigned the combination therapy (29.8 months versus 17.4 months). Patients in the triplet regimen group had a 41% reduction in the risk for death.

Researchers compared overall survival rates for both patient groups over a three-year period. Patients treated with Empliciti plus pomalidomide and dexamethasone had greater overall survival rates than those treated with pomalidomide and dexamethasone at one year (79% versus 68%), two years (63% versus 44%) and three years (39% versus 29%).

Patients with improved overall survival rates in the triple-therapy group were most often 75 years old or older, patients with more than four previous lines of therapy, those whose disease was refractory to both Revlimid and proteasome inhibitors and patients who were treated with Revlimid before receiving treatment in this study.

The safety of Empliciti, pomalidomide and dexamethasone was consistent with results from prior studies. In particular, the most common side effects included anemia and neutropenia, both of which are conditions that affect blood cell counts.

The Food and Drug Administration in 2018 granted Empliciti approval for the treatment of relapsed and refractory multiple myeloma after two or more prior therapies based on initial findings from the ELOQUENT-3 trial. In particular, these findings demonstrated that triplet therapy reduced the risk for disease progression by 46% and more than doubled the median progression-free survival rate (10.25 months versus 4.67 months) for patients treated with the triplet regimen.

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