Table 8.
Efficacy | Pembrolizumab 2 mg/kg Every 3 Weeks n = 180 | Pembrolizumab 10 mg/kg Every 3 Weeks n = 181 | Chemotherapy n = 179 |
---|---|---|---|
Progression-Free Survival | |||
Number of events, n (%) | 129 (72%) | 126 (70%) | 155 (87%) |
Progression, n (%) | 105 (58%) | 107 (59%) | 134 (75%) |
Death, n (%) | 24 (13%) | 19 (10%) | 21 (12%) |
Median in months (95% CI) | 2.9 (2.8, 3.8) | 2.9 (2.8, 4.7) | 2.7 (2.5, 2.8) |
p-Value (stratified log-rank) | <0.001 | <0.001 | – |
Hazard ratio * (95% CI) | 0.57 (0.45, 0.73) | 0.50 (0.39, 0.64) | – |
Objective Response Rate | |||
ORR, n% (95% CI) | 21% (15, 28) | 25% (19, 32) | 4% (2, 9) |
Complete response % | 2% | 3% | 0% |
Partial response % | 19% | 23% | 4% |
Hazard ratio * (KEYTRUDA compared to chemotherapy) based on the stratified Cox proportional hazard model.