Summary of clinical trials of first-line ICIs monotherapy for advanced NSCLC
| Study | Patient | Arm | ORR, % | DOR, median, months | PFS | OS | Grade ≥ 3 TRAEs, % | ||
|---|---|---|---|---|---|---|---|---|---|
| Median, months | HR (95% CI) | Median, months | HR (95% CI) | ||||||
| KEYNOTE-024 | PD-L1 TPS ≥ 50% advanced NSCLC | Pembrolizumab vs. chemotherapy | 44.8 vs. 27.8 | NR vs. 6.3 | 10.3 vs. 6.0 | 0.50 (0.37–0.68) | 26.3 vs. 13.4 | 0.62 (0.48–0.81) | 26.6 vs. 53.3 |
| KEYNOTE-042 | PD-L1 TPS ≥ 1% advanced NSCLC | Pembrolizumab vs. chemotherapy | 27 vs. 27 | 20.2 vs. 8.3 | 5.4 vs. 6.5 | 1.07 (0.94–1.21) | 16.7 vs. 12.1 | 0.81 (0.71–0.93) | 18 vs. 41 |
| IMpower110 | PD-L1 TC ≥ 50%/IC ≥ 10% advanced NSCLC | Atezolizumab vs. chemotherapy | 38.3 vs. 28.6 | NE | 8.1 vs. 5.0 | 0.63 (0.45–0.88) | 20.2 vs. 13.1 | 0.59 (0.40–0.89) | NE |
| EMPOWER-Lung 1 | PD-L1 TPS ≥ 50% advanced NSCLC | Cemiplimab vs. chemotherapy | 39 vs. 20 | 16.7 vs. 6.0 | 8.2 vs. 5.7 | 0.54 (0.43–0.68) | NR vs. 14.2 | 0.57 (0.42–0.77) | 14 vs. 39 |
ICI, immune checkpoint inhibitor; NSCLC, non-small cell lung cancer; TPS, tumor proportion score; TC, tumor cell; IC, immune cell; ORR, objective response rate; DOR, duration of response; PFS, progression-free survival; OS, overall survival; HR, hazard ratio; CI, confidence interval; NE, not evaluable; NR, not reached; TRAE, treatment-related adverse event.