Study
Double-blind, randomized Phase II-III trial |
Untreated metastatic or unresectable melanoma |
Relatlimab and nivolumab vs nivolumab alone |
Efficacy
mPFS: 10.1 vs 4.6 mos (HR:0.75; P=0.006) |
12 months PFS: 47.7% vs 36.0% |
PD L1<1 mPFS: 6.4 vs 2.9 mos (HR:0.66) |
PD L1>=1 mPFS: 15.7 vs 14.7 mos (HR:0.95) |
Safety
Most AE’s: Hypothyroidism or thyroiditis (in 18.0% of the patients), rash (in 9.3%), diarrhea or colitis (in 6.8%) in combination arm |
Grade >=3 increased levels of lipase (1.7%), ALT (1.4%), AST (1.4%), fatigue (1.1%) in combination arm |
N Engl J Med 2022; 386:24-34
Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma
http://doi.org/10.1056/NEJMoa2109970
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022