ELOQUENT-3 Trial: Elotuzumab Plus Pomalidomide/Dexamethasone in Resistant Myeloma
Posted: Tuesday, February 12, 2019
The addition of elotuzumab to pomalidomide and dexamethasone significantly improved progression-free survival among patients with relapsed and/or refractory multiple myeloma previously treated with lenalidomide and a proteasome inhibitor, according to the results of the phase II ELOQUENT-3 trial, published in The New England Journal of Medicine. Meletios A. Dimopoulos, MD, of the University of Athens, Greece, and colleagues also observed a lower risk of death among those who received elotuzumab compared with those who did not.
The authors randomly assigned 117 patients with relapsed and/or multiple myeloma to treatment with elotuzumab plus pomalidomide/dexamethasone (n = 60) or pomalidomide/dexamethasone (n = 57; control group). These patients came from 43 sites in Europe, North American, Japan, and Australia.
The elotuzumab group experienced significant improvements in overall response rates and in the risk of disease progression or death. The median progression-free survival among those treated with elotuzumab was 10.3 months versus 4.7 months in the control group. The hazard ratio for disease progression or death between the treatment and the control groups was 0.54 (P = .008). The overall response rates were significantly better among those treated with elotuzumab (53% vs. 26%). Treatment benefits appeared to be consistent across subgroups, including those who had multiple prior lines of therapy, disease stages I to III, and those with disease refractory to both lenalidomide and a proteasome inhibitor.
The most common grade 3 and 4 adverse events in the treatment and control groups included neutropenia (13% vs. 27%), anemia (10% vs. 20%), and hyperglycemia (8% vs. 7%). Within each group, 65% of patients developed infections.
“This trial showed the therapeutic potential of a second elotuzumab-based combination therapy for relapsed or refractory multiple myeloma,” the investigators commented. “Elotuzumab plus lenalidomide and dexamethasone is approved for multiple myeloma
after treatment with at least one previous therapy on the basis of the results of the phase [III] ELOQUENT-2 trial.”
Disclosure: See study authors’ full disclosures at nejm.org.