Table 1.
Characteristics of main studies with efficacy evaluation according to PD-L1 expression in the advanced setting.
| Study | Population (n) | Treatment | Method | Cut-Off(s) | Main Findings |
|---|---|---|---|---|---|
| Borghaei H, 2015 (CheckMate-057) [1] | 455 previously treated advanced non-squamous NSCLC evaluable for PD-L1 | Nivolumab (vs. docetaxel) | IHC 28-8 | TPS ≥ 1%, 5%, 10% | Association with longer OS, PFS, ORR, DOR at all cut-offs (secondary endpoints) |
| Herbst R, 2016 (KEYNOTE-010) [3] | 1034 previously treated NSCLC with PD-L1 at least ≥ 1% | Pembrolizumab (vs. docetaxel) | IHC 22C3 | TPS ≥ 1%, 50% | Association with longer OS at all cut-offs and longer PFS only at 50% cut-off (primary endpoints) |
| Rittmeyer A, 2016 (OAK) [4] | 850 previously treated NSCLC evaluated for PD-L1 expression | Atezolizumab (vs. docetaxel) | IHC SP142 | TC1/2/3 or IC1/2/3 | Association with longer OS at all cut-offs (coprimary endpoint) |
| Brahmer J, 2015 (CheckMate-017) [2] | 225 previously treated squamous-cell lung cancer evaluable for PD-L1 | Nivolumab (vs. docetaxel) | IHC 28-8 | TPS ≥ 1%, 5%, 10% | Association with longer OS, PFS at all cutoffs but no ORR (secondary endpoints) |
| Reck M, 2018 (KEYNOTE-024) [18] | 305 untreated NSCLC with PD-L1 ≥ 50% | Pembrolizumab (vs. platinum-based CT) | IHC 22C3 | TPS ≥ 50% | Association with longer OS (primary endpoints) |
| Gandhi L, 2018 (KEYNOTE-189) [22] | 616 untreated non-squamous NSCLC | Pembrolizumab/platinum/pemetrexed (vs. platinum/pemetrexed) | IHC 22C3 | TPS ≥ 1% | Association with longer OS and PFS regardless of PD-L1 (exploratory endpoints) |
| Paz-Ares L, 2018 (KEYNOTE-407) [20] | 559 untreated squamous-cell lung cancer | Pembrolizumab/ carboplatin/paclitaxel or nab-paclitaxel (vs. carboplatin/paclitaxel or nab-paclitaxel) |
IHC 22C3 | TPS ≥ 1% | Association with longer OS and PFS regardless of PD-L1 (exploratory endpoints) |
| Socinski M, 2018 (IMPOWER-150) [21] | 692 untreated non-squamous NSCLC evaluated for PD-L1 expression | Atezolizumab/carboplatin/paclitaxel/bevacizumab (vs. carboplatin/paclitaxel/bevacizumab) | IHC SP142 | TC1/2/3 or IC1/2/3 | Association with longer PFS at all cut-offs (secondary endpoint) |
NSCLC: non-small cell lung cancer; IHC: immunohistochemistry; TPS: tumor proportion score; OS: overall survival; PFS: progression-free survival; ORR: objective response rate; DOR: duration or response; TC/IC: tumor cells or tumor-infiltrating immune cell.