Table 2 Overview of Food and Drug Administration (FDA)- and European Medicines Agency (EMA)-approved predictive biomarkers for patient selection for immune checkpoint inhibition
From: Biomarkers for immune checkpoint inhibition in sarcomas – are we close to clinical implementation?
Predictive Biomarkers | Assay Methods | Antibody | Expression Threshold | Cancers | Regulatory Authority | NCT Number | Author, Year |
|---|---|---|---|---|---|---|---|
PD-L1 | PD-L1 IHC 22C3 pharmDx assay | Monoclonal mouse anti PD-L1 clone 22C3 | PD-L1 CPS ≥ 20 and CPS ≥ 1 | TNBC | FDA | NCT02622074 | Schmid et al., 2020 [61] |
CPS ≥ 1 | HNSCC | FDA/EMA | NCT02358031 | Burtness et al., 2019 [62] | |||
TPS ≥ 50% | NSCLC | FDA/EMA | NCT02142738 | Reck et al., 2019 [63] | |||
CPS ≥ 10 | UC | EMA | NCT02256436 | Bellmunt et al., 2017 [64] | |||
PD-L1 IHC 28–8 pharmDx assay | Monoclonal rabbit anti PD-L1 clone 28–8 | TPS ≥ 1% | NSCLC | FDA/EMA | NCT02477826 | Hellmann et al., 2019 [65] | |
VENTANA SP142 PD-L1 IHC assay | Monoclonal rabbit anti PD-L1 clone SP142 | IC ≥ 1% | TNBC | FDA/EMA | NCT02425891 | Schmid et al., 2018 [30] | |
TC ≥ 50% or IC ≥ 10% | NSCLC | FDA | NCT02008227 | Rittmeyer et al., 2017 [66] | |||
IC ≥ 5% | UC | FDA/EMA | NCT02108652 | Rosenberg et al., 2016 [67] | |||
VENTANA SP263 assay | Monoclonal rabbit anti PD-L1 clone SP263 | TC ≥ 25% or IC ≥ 25% | UBC | FDA | NCT01693562 | ||
MSI | PCR or IHC | - | MSI-H/dMMR | Colorectal cancer | FDA/EMA | NCT02460198 | Le et al., 2020 [69] |
Fluorescent Multiplex PCR-based method | - | MMR-deficient or proficient | Progressive metastatic carcinomas | FDA | NCT01876511 | Le et al., 2015 [70] | |
TMB | FoundationOne CDx assay | - | tTMB-high ≥ 10 mutations per Mb | Advanced solid tumors | FDA | NCT02628067 | Marabelle et al., 2020 [71] |
WES | - | NA | Advanced solid tumors | FDA | NCT02054806 | Ott et al., 2019 [72] |