Table II.

Major studies investigating pembrolizumab [Keytruda®] (anti-PD-1 immunotherapy) to treat meanoma

Enrollment period	Trial phase/Identifier	Patients	Randomization / Dosing regimen(s)	Primary endpoint / Results	Median follow-up duration	Common severe (grade 3-5) irAEs:
2012-2013	Phase 1, KEYNOTE-001, NCT01295827	Previously treated, ipilimuma-brefractory advanced melanoma, n=173	Pembrolizumab 2 mg/kg every 3 weeks, n=89 Pembrolizumab 10 mg/kg every 3 weeks, n=84	ORR: Pembrolizumab 2 mg/kg: 26% Pembrolizumab 10 mg/kg: 26%	8 mo.	Pembrolizumab 2 mg/kg: 3% Pembrolizumab 10 mg/kg: 0%
2013-2014	Phase 3, KEYNOTE-006, NCT01866319	Previously treated and untreated (65.8%) advanced melanoma patients, n=834	Pembrolizumab 10 mg/kg every 2 weeks, n=279 Pembrolizumab 10 mg/kg every 3 weeks, n=277 Ipilimumab 3 mg/kg (4 doses) every 3 weeks, n=278	6 mo-PFS, 12-mo OS, RR: Pembrolizumab 10 mg/kg every 2 weeks: 47.3%, 74.1%, 33.7% Pembrolizumab 10 mg/kg every 3 weeks: 46.4%, 68.4%, 32.9% Ipilimumab 3 mg/kg (4 doses) every 3 weeks: 26.5%, 58.2%, 11.9%	7.9 mo.	Pembrolizumab 10 mg/kg every 2 weeks: 13.3% Pembrolizumab 10 mg/kg every 3 weeks: 10.1% Ipilimumab 3 mg/kg (4 doses) every 3 weeks: 19.9%
2015-2016	Phase 3, EORTC132, KEYNOTE-054, NCT02362594	Previously treated, completely resected stage III melanoma patients, n=1019 PD-L1 positive subgroup, n=853	Pembrolizumab 200 mg every 3 weeks for a total of 18 doses (~1 year), n=514 Placebo every 3 weeks for a total of 18 doses (~1 year), n=505	RFS in overall intention to treat group: Pembrolizumab: 75.4% Placebo: 61.0% 1-year rate of RFS in PD-L1 positive subgroup: Pembrolizumab: 77.1% Placebo: 62.6%	15 mo.	Pembrolizumab: Pembrolizumab: 14.7% Placebo: 3.4%

Abbreviations: Overall survival (OS); Recurrence free survival (RFS); Objective response rate (ORR); Progression free survival (PFS); Response rate (RR)