Patients with relapsed or refractory multiple myeloma who received a combination of elotuzumab, lenalidomide, and dexamethasone had a 30% reduced risk for disease progression or death, a recent study published in The New England Journal of Medicine has shown.
In the phase 3, ELOQUENT-2 study, researchers enrolled 646 patients with relapsed or refractory multiple myeloma and randomly assigned 321 to receive elotuzumab plus lenalidomide and dexamethasone and 325 to lenalidomide and dexamethasone alone.
Results showed that after a median follow-up of 24.5 months, the 1-year progression-free survival rate was 68% in the elotuzumab group versus 57% in the control group. At 2 years, the rates were 41% and 27%, respectively.
Researchers found that median progression-free survival was 19.4 months with elotuzumab compared with 14.9 months in the control group (HR = 0.70; 95% CI: 0.57, 0.85; P<0.001). The overall response rate was 79% and 66%, respectively (P<0.001).
In regard to safety, the most frequently reported grade 3 or 4 adverse events were lymphocytopenia, neutropenia, fatigue, and pneumonia. Infusion reactions occurred in 10% of patients in the elotuzumab group, with the majority being grade 1 or 2.
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Elotuzumab is an immunostimulatory humanized monoclonal antibody that targets lymphocytic activation molecule F7 (SLAMF7). The immunotherapy was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in May 2014.
There are currently no FDA-approved monoclonal antibodies for the treatment of patients with multiple myeloma.
Preliminary findings of the ELOQUENT-2 study were presented at the 2015 ASCO Annual Meeting in Chicago, IL.
- Lonial S, Dimopoulos M, Palumbo A, et al. Elotuzumab therapy for relapsed or refractory multiple myeloma. N Engl J Med. 2015; 373:621-631.