3.1
The company presented clinical‑effectiveness evidence for pembrolizumab from 2 clinical trials: KEYNOTE‑006 and KEYNOTE‑001. KEYNOTE‑006 was a randomised, international, multicentre, phase 3 trial of pembrolizumab 10 mg/kg every 2 weeks (n=279) or every 3 weeks (n=277), continued until disease progression or unacceptable toxicity, compared with ipilimumab 3 mg/kg every 3 weeks, continued for 4 doses (n=278). Results were analysed at 2 planned interim analyses, after 6 months of follow‑up (September 2014) and after 9 to 12 months of follow‑up (March 2015). After the second interim analysis the study was stopped, because the primary endpoint had been met. KEYNOTE‑001 was a combined phase 1 and 2 study. Evidence was presented from a sub‑study of this trial, referred to as KEYNOTE‑001 part D: this was a randomised, open‑label study comparing pembrolizumab 2 mg/kg every 3 weeks (n=51; the licensed dose) with 10 mg/kg every 3 weeks (n=52). Both KEYNOTE‑006 and KEYNOTE‑001 part D included people with advanced melanoma, with or without BRAF mutations, who had not had ipilimumab before (previous treatment with 1 or 2 other therapies was permitted).