The fixed-dose combination of relatlimab plus nivolumab (Opdualag) for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.
RELATIVITY-047 trial (NCT03470922), in which relatlimab plus nivolumab demonstrated a 22% reduction in risk of progression or death and numerically improved overall survival rates compared to nivolumab alone.
Combination of two immunotherapies that may act together to help improve anti-tumor response by targeting two different immune checkpoints — LAG-3 and PD-1.
Relatlimab is a lymphocyte activation gene 3 (LAG-three) inhibitor.
PD-1 and LAG-3 contribute to a tumor microenvironment that leads to T cell exhaustion and allows tumor growth: targeting these immune checkpoints can lead to rejuvenation of T cells in the immune micro environment.
Relatlimab and nivolumab to demonstrate benefit compared to nivolumab alone in patients with previously untreated metastatic or unresectable melanoma, according to findings from the RELATIVITY-047 study.
A randomized, double-blind, phase 2/3 study, RELATIVITY-047, 714, patients with melanoma were randomized 1:1 and received relatlimab at 160 mg plus nivolumab at 480 mg fixed dose combination or nivolumab at 480 mg alone, given intravenously every 4 weeks.
At a median follow-up was 19.3 months, median PFS was 10.2 months with the combination compared to 4.6 months with nivolumab.
The median OS was not reached with the relatlimab and nivolumab combination while it was 34.1 months with nivolumab.
ORR was higher with relatlimab plus nivolumab and the safety profile of the combination remained manageable with no new or unexpected safety signals.
Further, OS rates at 12 months were 77.0% for the combination compared to 71.6% for nivolumab alone, and 24 months, OS rates were 63.7% versus 58.3%, respectively.
Complete responses were observed in 16.3% of patients on relatlimab and nivolumab and 14.2% on just nivolumab.
Relatlimab in combination with nivolumab had a manageable safety profile with no new or unexpected safety signals.
Inhibiting LAG-3 with relatlimab, in a fixed-dose combination with nivolumab, represents a new treatment approach.