PD-L1 IHC 22C3 pharmDx
The PD-L1 test tied to pembrolizumab, and the source of the 'CPS' number that decides immunotherapy in many cancers.
Overview
Approved 2 October 2015 (PMA P150013, Dako, now Agilent) as the companion diagnostic for pembrolizumab in non-small-cell lung cancer, initially at TPS ≥50% and from 2016 at TPS ≥1%. It has since been approved for gastric and gastro-oesophageal junction cancer (CPS ≥1, 2017), cervical cancer (CPS ≥1, 2018), head and neck squamous cell carcinoma (CPS ≥1, 2019), oesophageal squamous cell carcinoma (CPS ≥10, 2019) and triple-negative breast cancer (CPS ≥10, 2020, KEYNOTE-355). The many cut-offs are a source of confusion for patients: the same stain is read differently depending on the cancer and the trial that set the threshold.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Companion diagnostic for pembrolizumab in NSCLC (TPS) |
| US | 2017 | Gastric / GEJ adenocarcinoma, CPS ≥1 |
| US | 2019 | Head and neck squamous cell carcinoma (CPS ≥1) and oesophageal squamous cell carcinoma (CPS ≥10) |
| US | 2020 | Triple-negative breast cancer, CPS ≥10 (pembrolizumab plus chemotherapy) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: the report gives a TPS or CPS; whether it counts as 'positive' depends on the drug label for your cancer, so the same number can be positive in one cancer and negative in another.
Latest papers
topQuery for this drug: (TITLE:"PD-L1 IHC 22C3 pharmDx" OR ABSTRACT:"PD-L1 IHC 22C3 pharmDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about PD-L1 IHC 22C3 pharmDx, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductVENTANA PD-L1 (SP263) Assay
Shares PD-L1 expression testing (22C3, SP142, SP263), VENTANA PD-L1 (SP142) Assay, Immunohistochemistry (IHC), Companion diagnostics and the tag test.
- ProductHER2 IHC and ISH companion assays (HercepTest, PATHWAY 4B5, HER2 Dual ISH)
Shares Agilent Technologies (Dako), Immunohistochemistry (IHC), Companion diagnostics, Histopathology & immunohistochemistry and the tag test.
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- ProductRaDaR
Shares Head and neck squamous cell carcinoma, Triple-negative breast cancer (TNBC), Non-small-cell lung cancer and the tag test.
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- Productcobas EGFR Mutation Test v2
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- ProductBRACAnalysis CDx
Shares Companion diagnostics, Triple-negative breast cancer (TNBC) and the tag test.