Table 1. . Summary of Phase I and II results of pembrolizumab in advanced melanoma.

Phase	Response rate (%)†	Median PFS† (months)	Median OS	Toxicity	Ref.
Phase I	38 (RECIST)	7	Not reached	Fatigue, rash, pruritus, diarrhea;	[19]
IpiN and IpiT	37 (irRC)			12% grade 3/4 adverse events
n = 135
Phase I	26 (RECIST)	4.5 (RECIST)	Not reached	Fatigue, rash, pruritus;	[18]
IpiT	30 (irRC)	8.0 (irRC)	12 month OS 61%	13% grade 3/4 adverse events
n = 173
Phase I	34	5.2	Not reached.	14% grade 3/4 adverse events	[50]
IpiN and IpiT (pooled)			12 month OS 67%
n = 665 (abstract)
Phase II	24	2.9 (independent review RECIST)	Not reached	14% grade 3/4 adverse events	[51]
IpiT		4.6 (investigator review RECIST)
n = 540 (abstract)

^†Response rates and median PFS given as average of dose (2 or 10 mg/kg) and schedules tested (2 and 3 weekly).

IpiN: Ipilimumab naive; IpiT: Ipilimumab treated; irRC: Immune-related response criteria; OS: Overall survival; PFS: Progression-free survival; RECIST: Response evaluation criteria in solid tumors.