Table 1. Summary of the main phase 2/3 clinical trials evaluating pembrolizumab in lung cancer.
| Study | Reference | Phase | N | Purposes | Results |
|---|---|---|---|---|---|
| KEYNOTE-021: NCT02039674 | Langer et al. 2016 | 2 | 123 | Carboplatin and pemetrexed with or without pembrolizumab | An objective response was achieved in 55% (33/60) of patients in the pembrolizumab plus chemotherapy group compared with 29% (18/63) in the chemotherapy alone group (P=0.0016) |
| NCT02879994 | Lisberg et al. 2018 | 2 | 11 | Pembrolizumab in EGFR-mutant, PD-L1 positive (>1%), TKI naïve patients | Lack of efficacy of pembrolizumab in TKI naïve, EGFR-mutant, PD-L1 patients even in case of PD-L1 expression >50% |
| KEYNOTE-010: NCT01905657 | Herbst et al. 2016 | 2/3 | 1,034 | Pembrolizumab vs. docetaxel for previously treated PD-L1 positive (>1%) NSCLC | OS was significantly longer for pembrolizumab vs. docetaxel (HR P=0.0008) |
| No significant difference was achieved in PFS between pembrolizumab and docetaxel groups | |||||
| In the subgroup of patients with PD-L1 positive tumours (expression >50%), OS and PFS were significantly longer with pembrolizumab than with docetaxel (P<0.001) | |||||
| NCT02142738 | Reck et al. 2016 | 3 | 305 | Pembrolizumab vs. chemotherapy for PD-L1 positive (>50%) previously untreated advanced NSCLC | Median PFS was 10.3 months with pembrolizumab vs. 6 months with chemotherapy (P<0.001) |
| Estimated OS at 6 months was 80.2% in the pembrolizumab group vs. 72.4% in the chemotherapy group (P=0.005) | |||||
| The RR was 44.8% with pembrolizumab vs. 27.8% with chemotherapy | |||||
| NCT02578680 | Gandhiet al. 2018 | 3 | 616 | Pembrolizumab plus chemotherapy in previously untreated advanced non-squamous NSCLC | Estimated OS rate at 12 months was 69.2% in the pembrolizumab plus chemotherapy group vs. 49.4% in the chemotherapy group (P<0.001) |
| An increased expression of PD-L1 significantly improved OS | |||||
| Median PFS was significantly longer in pembrolizumab plus chemotherapy group compared with chemotherapy group (8.8 vs. 4.9 months respectively, P<0.001) |
OS, overall survival; TKI, tyrosine kinase inhibitor; PFS, progression-free survival; NSCLC, non-small cell lung cancer; RR, response rate.