Table 1.
The clinical trials when PD-L1 expression as a biomarker.
| Trial | Phase | Treatment and target | Tumor type | PD-L1 stratification | Testing method | Endpoint | References |
|---|---|---|---|---|---|---|---|
| KEYNOTE 180 (NCT02559687) |
Phase II, open-label, single-arm | Pembrolizumab, PD-1 | Advanced ESCC/GEJC | PD-L1 (+): CPS ≥ 10 PD-L1 (–): CPS <10 |
IHC 22C3 pharmDx assay | mOS, OSR, DCR | (35) |
| KEYNOTE 181 (NCT02564263) |
Phase III, open-label, RCT | Pembrolizumab, PD-1 | Advanced/Metastatic EC | PD-L1 (+): CPS ≥ 10 PD-L1 (–): CPS <10 |
IHC 22C3 pharmDx assay | mOS, PFS | (36) |
| KEYNOTE 590 (NCT03189719) |
Phase III, placebo-controlled, RCT | Pembrolizumab, PD-1 | Advanced/Metastatic EC | PD-L1 (+): CPS ≥ 10 PD-L1 (–): CPS <10 |
IHC 22C3 pharmDx assay | mOS | (8) |
| ATTRACTION-3 (NCT02569242) |
Phase III, open-label, RCT | Nivolumab, PD-1 | Unresectable/Recurrent ESCC | PD-L1 TPS ≥1, 5, 10% | IHC 28-8 pharmDx assay | mOS | (4) |
| CheckMate 649 (NCT02872116) |
Phase III, open-label, RCT | Nivolumab, PD-1 | Advanced GEJC/GC | PD-L1 (+): CPS ≥ 5 PD-L1 (–): CPS <5 |
IHC 28-8 pharmDx assay | mOS, PFS | (5) |
| KEYNOTE 062 (NCT02494583) |
Phase III, RCT | Pembrolizumab, PD-1 | Advanced GC/GEJC | PD-L1 CPS ≥ 1, 5, 10 | IHC 22C3 pharmDx assay | mOS, PFS | (39) |
RCT, randomized clinical trial; PD-1, programmed death-1; PD-L1, programmed death-ligand 1; GC, gastric cancer; GEJC, gastroesophageal junction cancer; ESCC, esophageal squamous cell cancer; CPS, combined positive score; TPS, tumor proportion score; IHC, immunohistochemistry; mOS, median overall survival; PFS, progression free survival.