Table 2.
Key Parameters for Use of FDA Approved PD-L1 Testing for Immune Checkpoint Inhibitors.
| Test Name | PMA# | Tumor Type | ICI | Approval Year | Scoring System | PD-L1-Threshold | PD-L1 Staining |
|---|---|---|---|---|---|---|---|
| PD-L1 IHC 22C3 pharmDx | P150013 | NSCLC | Pembrolizumab | 2015 | TPS | >=50% | tumor cells |
| PD-L1 IHC 22C3 pharmDx | P150013/S006 | gastric or GEJ adenocarcinoma | Pembrolizumab | 2017 | CPS | >=1 | tumor cells, lymphocytes, macrophages |
| PD-L1 IHC 22C3 pharmDx | P150013/S009 | Cervical Cancer | Pembrolizumab | 2018 | CPS | >=1 | tumor cells, lymphocytes, macrophages |
| PD-L1 IHC 22C3 pharmDx | P150013/S011 | urothelial carcinoma | Pembrolizumab | 2018 | CPS | >=10 | tumor cells, lymphocytes, macrophages |
| PD-L1 IHC 22C3 pharmDx | P150013/S014 | head and neck squamous cell carcinoma | Pembrolizumab | 2019 | CPS | >=1 | tumor cells, lymphocytes, macrophages |
| PD-L1 IHC 22C3 pharmDx | P150013/S016 | esophageal squamous cell carcinoma | Pembrolizumab | 2019 | CPS | >=10 | tumor cells, lymphocytes, macrophages |
| VENTANA PD-L1(SP142) Assay | P160002/S006 | urothelial carcinoma/NSCLC | atezolizumab | 2018 | IC%/IC% or TPS | >=5%/>=10% or >=50% | tumor area/tumor area, tumor ells |
| VENTANA PD-L1(SP142) Assay | P160002/S009 | Triple-Negative Breast Carcinoma | atezolizumab | 2019 | IC% | >=1% | tumor area |
| VENTANA PD-L1(SP142) Assay | P160002/S012 | NSCLC | atezolizumab | 2020 | IC%/TPS | >=10%/>=50% | tumor area Tumor cells |
| PD-L1 IHC 28-8 pharmDx | P150025/S013 | NSCLC/SCCHN/UC | Nivolumab in combination with ipilimumab | 2020 | TPS | >=1% | tumor cells |
| PD-L1 IHC SP263 | P160046 | urothelial carcinoma | Durvalumab | 2017 | TPS/ICP/IC+ | >=25%/ICP > 1% and IC+ >=25%/ICP = 1% and IC+ = 100%. | tumor cells Immune cells |