Table 1.
Assay Antibodies PD-L1 clone | Staining platform | FDA designed | Immunotherapy drug | PD-L1 binding domain | Clinical cutoff(s) for PD-L1 expression |
---|---|---|---|---|---|
28-8 | Dako Link 48 | Complementary diagnostic | Nivolumab | Tumor cells | ≥ 1%, ≥ 5% |
22C3 | Dako Link 48 | Companion | Pembrolizumab | Tumor cells | ≥ 1%, ≥ 50% |
SP142 | Ventana Benchmark or Ultra | Complementary diagnostic | Atezolizumab | Tumor cells and/or | ≥ 1%, ≥ 5%, ≥ 50% |
Infiltrating immune cells | ≥ 1%, ≥ 5%, ≥ 10% | ||||
SP263 | Ventana Benchmark or Ultra | No designed | Durvalumab | Tumor cells | ≥ 25% |
73-10 | Dako Link 48 | Under development | Avelumab | Tumor cells | ≥ 1%, ≥ 5%, ≥ 80% |
Clinical cutoff(s) for PD-L1 expression of five-assay comparison