Clinical studies about pembrolizumab
| Indication | Study | ||||||||
| Reference &
clinical trial | n | Objective
response rate (ORR) % (95%CI) | Treatment-
related (TR) all grades adverse events (%) | TR grade
3–4 adverse events (%) | Survival vs.
control therapy survival | Control
therapy & ORR % (95% CI) | Control
therapy TR all grades adverse events (%) | Control
therapy TR grade 3–4 adverse events (%) | |
| Unresectable or metastatic melanoma | Schachter
et al.44 (KEYNOTE- 006) | 279
(10 mg/kg every 2 weeks) | 37
(31–43) | 82
(n=278) | 17
(n=278) | 55% vs. 43%
(24-month overall survival rate) | Ipilimumab 13 (10–18) (n=278) | 74
(n=256) | 20
(n=256) |
| Metastatic non-small cell lung cancer with PD-L1 expression | Reck et al.45
(KEYNOTE- 024) | 154 | 44.8
(36.8–53.0) | 73.4 | 26.6 | 80.2% vs. 72.4%
(6-month overall survival rate) | Chemotherapy 27.8 (20.8–35.7) (n=151) | 90 (n=150) | 53.3 (n=150) |
| Recurrent or metastatic head and neck squamous cell carcinoma | Mehra
et al.46 (KEYNOTE- 012) | 192 | 17.7
(12.6–23.9) | 64 | 12 | 8.5 months (median overall survival) | |||
| Refractory classical Hodgkin's lymphoma | Chen et al.47
(KEYNOTE- 087) | 210 | 69
(62.3–75.2) | 28.6 | |||||
| Locally advanced or metastatic urothelial carcinoma | Balar et al.48
(KEYNOTE- 52) | 370 | 24
(20–29) | 61 | 15 (one case has grade 5 myositis) | 2 months (median progression-free survival) | |||
| MSI-H or dMMR solid tumors | Le et al.28
Diaz et al.29 Seiwert et al.30 | 149 | 39.6
(31.7–47.9) | ||||||
| Gastric cancer with PD-L1 expression | Fuchs et al.49
(KEYNOTE- 059) | 259 | 11.2
(7.6–15.7) | ||||||