Daratumumab plus lenalidomide resulted in superior progression-free survival (PFS) outcomes compared with lenalidomide plus dexamethasone in frail patients with previously untreated multiple myeloma (MM). The safety profile of the experimental treatment regimen was favorable.
The phase 3 IFM2017-03 trial (NCT03993912) randomly assigned 295 frail patients (based on ECOG proxy frailty assessment) of at least 65 years of age with newly diagnosed MM 2:1 to daratumumab plus lenalidomide or lenalidomide plus dexamethasone1. The primary endpoint of the trial was PFS.
After a median follow-up of 46.3 months, the daratumumab group outperformed the dexamethasone group in terms of median PFS (53.4 vs 22.5 months; HR 0.51; 95% CI 0.37–0.70; P<0.0001). “This represents a 49% reduction in the risk for progression or death for participants on daratumumab,” said Salomon Manier, MD, PhD, from the University of Lille, in France. Similarly, the median overall survival was significantly longer in the daratumumab group than in the dexamethasone group (not reached vs 47.2 months; HR 0.52; 95% CI 0.35–0.77; P=0.0001).
Grade 3 or higher neutropenia (55% vs 24%), anemia (12% vs 3%), and thrombocytopenia (10% vs 5%) were more frequently observed in the daratumumab arm. “There were no differences between the study arms concerning infections or treatment discontinuations,” added Dr. Manier.
“The phase 3 IFM2017-03 trial demonstrated that a dexamethasone-sparing strategy is efficacious and safe for treating frail patients with previously untreated MM,” decided Dr. Manier.
Medical writing support was provided by Robert van den Heuvel.
Copyright ©2024 Medicom Medical Publishers
