In the phase III #KEYNOTE-716 trial published in the Lancet, Adjuvant #pembrolizumab improved the clinical outcomes compared to placebo in in patients with resected stage IIB and IIC #melanoma
In this randomized, double blind trial, 976 patients with high risk stage II melanoma were randomized to either 200 mg of pembrolizumab or placebo, both intravenously, every 3 weeks for 17 cycles.
After median follow-up of 27·4 months, Adjuvant pembrolizumab was associated with a significant improvement in distant-metastasis free survival (24-months DMFS rate: 88.1% vs 82.2%; HR= 0·64, p=0·0029) and a decrease in the risk of recurrence (24-months RFS rate: 81.2% vs 72.8%; HR 0·64) compared to placebo. No new safety signals with this analysis, the most common grade 3 or worse adverse events were hypertension, diarrhea, rash , autoimmune hepatitis, and increased lipase. No treatment-related deaths were reported.