Table 2.
PD-L1 IHC assay systems as companion and complementary diagnostic assays for NSCLC treatment using anti-PD-1/PD-L1 agents.
| Assay system | Source and antibody clonality | Therapeutic antibody | Type of tissue | Detection systems required | Instrument | TPS | Company | Cancer |
|---|---|---|---|---|---|---|---|---|
| PD-L1 IHC 28-8 pharmDx Dako | Rabbit monoclonal | Nivolumab | FFPE | Autostainer Link 48 | EnVision FLEX visualization system | Tumor cell membrane staining | Dako Autolink 48 | Nonsquamous NSCLC |
| PD-L1 IHC 22C3 pharmDx Dako | Mouse monoclonal | Pembrolizumab | FFPE | Autostainer Link 48 | EnVision FLEX visualization system | Tumor cell membrane staining | Dako Autolink 48 | NSCLC |
| Ventana PD-L1 (SP142) assay | Rabbit monoclonal | Atezolizumab | FFPE | OptiView Amplification | Ventana BenchMark ULTRA | Tumor cell membrane and immune cell staining | Ventana Ultra | NSCLC |
| Ventana PD-L1 (SP263) | Rabbit monoclonal | Durvalumab | FFPE | OptiView Amplification | Ventana BenchMark ULTRA | Tumor cell membrane staining | Ventana Ultra | NSCLC |
FFPE: formalin-fixed paraffin-embedded; IC: immune cells; NSCLC: non-small-cell lung cancer; PD-1: programmed death-1; PD-L1: programmed death-ligand 1; TC: tumor cells; TPS: tumor proportion score.