pembrolizumab
pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle for up to 1 year
placebo
placebo every 3 weeks for a total of 18 doses (approximately 1 year)
patients were eligible for crossoveror repeat treatment with pembrolizumab
mML - NA - PDL1 positive
Membranous PD-L1 expression in tumor and tumor-associated immune cells was assessed by an immunohistochemistry assay and scored on a scale of 0-5; a score >=2 (staining on . 1% of cells) was considered PD-L1 positive
double-blind
123 centers in 23 countries
P3/ one sided test procedure with one interim analysis. Hierarchy RFS (ITT then PDL1) MFS (ITT then PDL1) AND OS (ITT then PDL1) A SUIVRE
As adjuvant therapy for high-risk stage III melanoma, pembrolizumab resulted in significantly longer RFS and DMFS than placebo and provided a sustained and clinically meaningful improvement in RFS at 5-year median follow-up. Same results were observed in the PDL1 positive population.