Table 4.
Phase III first line metastatic immunotherapy + chemotherapy
|
|
IMpassion130 (PD-L1 inhibitor)
|
Keynote-355 (PD1 inhibitor)
|
IMpassion131 (PD-L1 inhibitor)
|
| Drugs | Atezolizumab/nab-paclitaxel vs placebo/nab-paclitaxel | Pembrolizumab + chemotherapy (nab-paclitaxel or paclitaxel or gemcitabine/carboplatin vs placebo + chemo | Atezolizumab/paclitaxel vs placebo/paclitaxel |
| ITT (N) | 451 vs 451 (1:1 randomisation) | 566 vs 281 (2:1 randomisation) | 430 vs 221 (2:1 randomisation) |
| Inclusion | ≥ 1 yr DFI | ≥ 6 mo DFI | ≥ 1 yr DFI |
| PD-L1 status | IC [positive (≥ 1%) vs negative (< 1%)] | CPS [positive (≥ 1%) vs negative (< 1%)] | IC [positive (≥ 1%) vs negative (< 1%)] |
| SP142 antibody ventana platform | PD-L1 IHC 22C3 pharmDx kit | SP142 antibody ventana platform | |
| Primary endpoints | PFS and OS in ITT population | PFS and OS by PD-L1 status (CPS ≥ 10 and ≥ 1) in ITT | PFS and OS in PD-L1 positive cohort |
| Median FU | 18.0 mo (ASCO 2019) | 25.9 mo and 26.3 mo (ASCO 2020) | 8.6 and 9 mo (ESMO 2020) |
| PFS in PD-L1 + | 7.5 mo vs 5 mo | 9.6 mo vs 5.6 mo | 5.7 mo vs 5.6 mo |
| OS in PD-L1 + | 25.4 mo vs 17.9 mo | Awaited | 22.1 mo vs 28.3 mo |
PD-1: Programmed death 1; PD-L1: Programmed death-ligand 1; ITT: Intention-to-treat; DFI: Disease Free Interval; IHC: Immunohistochemistry; OS: Overall survival; ASCO: American Society of Clinical Oncology; ESMO: European Society of Medical Oncology; PFS: Progression free survival; CPS: Combined positive score.