Phase III randomised trials of PD-1 and PD-L1 inhibitors showing efficacy results and the technologies used for PD-L1 testing
| CheckMate 017 [83] | CheckMate 057 [84] | CheckMate 026 [87] | Keynote 010 [85] | Keynote 024 [86] | OAK [88] | |||||||
| Population | sNSCLC | nsNSCLC | PD-L1 ≥1% | PD-L1 ≥1% | PD-L1 ≥50% | NSCLC | ||||||
| Treatment line | ≥Second-line | ≥Second-line | First-line | ≥Second-line | First-line | ≥Second-line | ||||||
| Drug | Nivo | Doce | Nivo | Doce | Nivo | Chemo | Pembro | Doce | Pembro | Chemo | Atezo | Doce |
| ORR % | 20 | 9 | 19 | 12 | 26.1 | 33.5 | 18 | 9 | 44.8 | 27.8 | 14 | 13 |
| PFS months | 3.5 | 2.8 | 2.3 | 4.2 | 4.2 | 5.9 | 3.9, 4.0# | 4.0 | 10.3 | 6.0 | 2.8 | 4.0 |
| Overall survival months | 9.2 | 6.0 | 12.2 | 9.4 | 14.4 | 13.2 | 10.4, 12.7# | 8.5 | 80.2%¶ | 72.4%¶ | 13.8 | 9.6 |
| PD-L1 expression | ||||||||||||
| Antibody | 28-8 | 28-8 | 28-8 | 22C3 | 22C3 | SP142 | ||||||
| Platform manufacturer | Dako | Dako | Dako | Dako | Dako | Ventana | ||||||
| Analysed cells | Tumour cells | Tumour cells | Tumour cells | Tumour cells | Tumour cells | Tumour and immune cells | ||||||
| Thresholds | 1%, 5%, 10% | 1%, 5%, 10% | 1%, 5%, 10% | 1%, 50% | 1%, 50% | Tumour: 1%, 5%, 50%; Immune: 1%, 5%, 10% | ||||||
| Sampling time | Pretreatment | Pretreatment | Pretreatment | Any | Pretreatment | Pretreatment | ||||||
| Preanalytic | Archival FFPE | Archival FFPE | Archival FFPE | Archival or new | Archival or new | Archival or new | ||||||
ORR: objective response rate; PFS: progression-free survival; PD-L1: programmed cell death ligand 1; NSCLC: nonsmall cell lung cancer; Nivo: nivolumab; Doce: docetaxel; Chemo: chemotherapy; Pembro: pembrolizumab; Atezo: atezolizumab; FFPE: formalin-fixed paraffin-embedded. #: two doses of pembrolizumab were tested (2 mg·kg−1 and 10 mg·kg−1); ¶: 6-month overall survival rate.