Table 2. HR for PFS and OS and HR PFS/OS rate for the main randomized phase II and III clinical trials of single agent ICI in advanced NSCLC patients.
| Trial | Phase | Line | ICI | Treatment arms | Patients (n) | mOS (month) | HR OS | mPFS (month) | HR PFS | HR PFS/OS |
|---|---|---|---|---|---|---|---|---|---|---|
| Checkmate 017 (37) | III | ≥2nd | Nivolumab | Nivolumab 3mg/kg q2 weeks; docetaxel | 135; 137 | 9.2; 6 | 0.59 | 3.5; 2.8 | 0.62 | 1.05 |
| Checkmate 057 (38) | III | ≥2nd | Nivolumab | Nivolumab 3mg/kg q2 weeks; docetaxel | 292; 290 | 12.2; 9.4 | 0.73 | 2.3; 4.2 | 0.92 | 1.26 |
| Checkmate 026 (39) | III | 1st | Nivolumab | Nivolumab 3mg/kg q2 weeks; platinum-based CT | 271; 270 | 14.4; 13.2 | 1.02 | 4.2; 5.9 | 1.15 | 1.12 |
| KEYNOTE 010 (25) | II/III | ≥2nd | Pembrolizumab | Pembrolizumab 10 mg/kg q3 weeks; pembrolizumab 2 mg/kg q3 weeks; docetaxel | 346; 345; 343 | 12.7; 10.4; 8.5 | 0.71* | 4; 3.9; 4 | 0.88* | 1.23 |
| KEYNOTE 024 (40) | III | 1st | Pembrolizumab | Pembrolizumab; platinum-based CT | 154; 151 | 30; 14.2 | 0.63 | 10.3; 6 | 0.50 | 0.79 |
| POPLAR (41) | II | ≥2nd | Atezolizumab | Atezolizumab 1,200 mg q3 weeks; docetaxel | 144; 143 | 12.6; 9.7 | 0.77 | 2.7; 3 | 0.98 | 1.27 |
| OAK (42) | III | ≥2nd | Atezolizumab | Atezolizumab 1,200 mg q3 weeks; docetaxel | 425; 425 | 13.8; 9.6 | 0.73 | 2.8; 4 | 0.95 | 1.31 |
*, comparison pembrolizumab 2 mg/kg q3 weeks versus docetaxel; ICI, immune checkpoint inhibitors; q, every; mOS, median overall survival; HR, hazard ratio; mPFS, median progression free survival; CT, chemotherapy.