REALITIVTY-047 Study Design Shows Mature Response Results in Melanoma
Source: Targeted Oncology, March 2023
Jason Luke, MD, associate professor of medicine in the Division of Hematology/Oncology and the director of the Cancer Immunotherapeutics Center at the UPMC Hillman Cancer Center, discusses the unique design of the RELATIVITY-047 trial (NCT03470922) that demonstrated the efficacy of nivolumab (Opdivo) plus relatlimab (Opdualag) in patients with advanced melanoma.
The phase 2/3 global, double-blind, randomized trial evaluated the fixed dose combination of the PD-1 and LAG-3 immunotherapy combination against nivolumab alone for patients with previously untreated metastatic or unresectable melanoma.
Ultimately, the study met its primary end point of progression-free survival (PFS) with a median PFS of 10.1 months (95% CI, 6.4-15.7) for patients on the combination therapy compared with 4.6 months (95% CI, 3.4-5.6) with nivolumab alone (HR, 0.75; 95% CI, 0.62-0.92, P = .006). At 12-months the PFS rate still favored the combination therapy vs the monotherapy at 47.7% vs 36.0%, respectively, and key subgroups experienced similar PFS benefits with the addition of relatlimab.