TABLE I.
Selected clinical trials of PD-1/PD-L1 inhibitors as monotherapy in non-small-cell lung cancer (NSCLC)
| Trial name | Study drug | Phase | Indication | Population | Survival (months) | Response rate (%) | |
|---|---|---|---|---|---|---|---|
|
| |||||||
| Progression-free | Overall | ||||||
| CheckMate 01269 | Nivolumab | I | First line | 52 Advanced NSCLC | 3.6 (PD-L1≥50%: 8.4) | 21.8 | 23 (PD-L1≥50%: 50) |
| CheckMate 01710 | Nivolumab Docetaxel |
III | Second line | 272 Advanced squamous NSCLC | 4.2 3.5 (HR: 0.62; p<0.001) |
9.2 6.0 (HR: 0.59; p<0.001) |
20 9 (p=0.008) |
| CheckMate 05756 | Nivolumab Docetaxel |
III | Second line | 582 Advanced nonsquamous NSCLC | 2.3 4.2 (HR: 0.92; p=0.39) |
12.2 9.4 (HR: 0.72; p<0.001) |
19 12 (p=0.02) |
| CheckMate 02670 | Nivolumab Platinum-based chemotherapy (up to 6 cycles) |
III | First line | 423 Advanced NSCLC, PD-L1–positive, no EGFR or ALK mutation | 4.2 5.9 (HR: 1.15; p=0.25) |
Not reported | Not reported |
| KEYNOTE 00171 | Pembrolizumab | I | Second line | 495 Advanced NSCLC, PD-L1–positive, no EGFR mutation | 3.7 | 12.0 | 19.4 |
| KEYNOTE 01012 | Pembrolizumab (2 mg/kg) Pembrolizumab (10 mg/kg) Docetaxel |
II/III | Second line | 1034 Advanced NSCLC, PD-L1–positive | 3.9 vs. control (HR: 0.88; p=0.07) 4.0 vs. control (HR: 0.79; p<0.004) vs. 2 mg/kg (HR: 1.09) 4.0 |
10.4 vs. control (HR: 0.71; p=0.0008) 12.7 vs. control (HR: 0.61; p<0.0001) vs. 2mg/kg (HR: 1.17) 8.5 |
18 vs. control (p=0.0005) 18.5 vs. control (p=0.0002) 9.3 |
| KEYNOTE 02411 | Pembrolizumab Platinum-based chemotherapy (4–6 cycles) |
III | First line | 305 Advanced NSCLC PD-L1–positive, no EGFR or ALK mutation | 10.3 6.0 (HR: 0.50; p<0.001) |
6-Month rate: 80.2% 6-Month rate: 72.4% (HR: 0.60; p=0.005) |
44.8 27.8 |
| POPLAR48 | Atezolizumab Docetaxel |
II | Second line | 287 Advanced NSCLC | 2.7 3.0 (HR: 0.94) |
12.6 9.7 (HR: 0.73; p=0.04) |
15 15 |
| OAK72 | Atezolizumab Docetaxel |
III | Second line | 850 Advanced NSCLC | 2.8 4.0 (HR: 0.95; p=0.49) |
13.8 9.6 (HR: 0.73; p=0.0003) |
13.6 13.4 |
| BIRCH73 | Atezolizumab | II | First line | 142 PD-L1–positive, | 7.3 | 13.8 | 13.6 |
| PACIFIC74 | Durvalumab Placebo |
III | Second line (consolidation) | 709 stage III NSCLC with ≥2 rounds of platinum-based chemotherapy and radiotherapy with no progression | 16.8 5.6 (HR: 0.52; p<0.001) |
23.2a 14.6a (HR: 0.52; p<0.001) |
28.4 16.0 (p<0.001) |
a
Death or distant metastasis.