Trial | IMpower133 [4, 83] | KEYNOTE-604 [82] | Pembrolizumab maintenance [86] | KEYNOTE-158 [90] | ||||
Study phase | III | III | II | II | ||||
Setting | First-line | First-line | Maintenance | ≥2nd line | ||||
Treatment | Carboplatin+etoposide ± atezolizumab | Platinum salt+etoposide ± pembrolizumab | Pembrolizumab | Pembrolizumab | ||||
Total patients | 403 | 453 | 45 | 107 | ||||
PD-L1 evaluated patients | 137 | 360 | 20 | 65 | ||||
PD-L1 IHC | SP263 | 22C3 | 22C3 | 22C3 | ||||
PD-L1 status | TC or IC | CPS | Stromal interface | CPS | ||||
<1% | ≥1% | <1% | ≥1% | Negative | Positive | <1% | ≥1% | |
65 | 72 | 175 | 185 | 12 | 8 | 50 | 15 | |
PFS data according to PD-L1 status | HR | HR | mPFS (months) | mPFS (months) | ||||
0.51 (0.30–0.89) | 0.87 (0.5–1.49) | 0.80 (0.58–1.11) | 0.84 (0.60–1.18) | 1.3 (0.6–2.5) | 6.5 (1.1–12.8) | 1.9 (1.6–2.0) | 2.1 (2.0–8.1) | |
6-month PFS | ||||||||
14.3% | 38.9% | |||||||
12-month PFS | ||||||||
8.2% | 28.5% | |||||||
OS data according to PD-L1 status | NA | NA | 0.73 (0.54–1.01) | 0.68 (0.49–0.94) | mOS (months) | mOS (months) | ||
7.6 (2.0–12.7) | 12.8 (1.1–17.6) | 5.9 (3.3–10.1) | 14.9 (5.6–NR) | |||||
6-months OS | ||||||||
48.3% | 66% | |||||||
12-months OS | ||||||||
30.7% | 53.1% |
Data between parenthesis indicate 95% confidence intervals. IHC: immunohistochemistry; mPFS: median progression-free survival; mOS: median overall survival; OS: overall survival; TC: tumour cells; IC: immune cells; HR: hazard ratio; NA: not available; CPS: combined positive score.