Table 2 FDA-approved predictive biomarkers for the immune response of ICB
From: Immune checkpoint therapy for solid tumours: clinical dilemmas and future trends
Biomarker | Detail | Description | Trade name |
|---|---|---|---|
PD-L1 | PD-L1 protein expression | A qualitative immunohistochemical assay used in the assessment of the PD-L1 protein in tumour tissue | Dako PD-L1 IHC 22C3 PharmDx Assay Dako PD-L1 IHC 28-8 pharmDx Assay Ventana PD-L1 (SP142) Assay VENTANA PD-L1 (SP263) Assay |
dMMR proteins | MLH1, PMS2, MSH2 and MSH6 | A qualitative immunohistochemistry assay used in the assessment of MMR proteins (MLH1, PMS2, MSH2 and MSH6) in tumour tissue by light microscopy | Ventana MMR RxDx Panel |
MSI-High | Microsatellite instability-High (MSI-H) | A next-generation sequencing-based detection of genomic signatures including MSI and TMB using DNA isolated from tumour tissue or blood | FoundationOne CDx |
TMB | TMB ≥ 10 mutations per megabase | A next-generation sequencing-based detection of genomic signatures including MSI and TMB using DNA isolated from tumour tissue or blood | FoundationOne CDx |
