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Updated: Nov 1, 2025
Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
Analytical Concordance of PD-L1 Assays Utilizing Antibodies From FDA-Approved Diagnostics in Advanced Cancers: A
Emily A Prince1, Jenine K Sanzari1, Dimple Pandya1
1Bristol Myers Squibb, Princeton, NJ.
Abstract:
Four programmed death ligand 1 (PD-L1) immunohistochemistry assays (28-8, 22C3, SP263, and SP142) have been approved for use by the US Food and Drug Administration (FDA). Analytical concordance between these assays has been evaluated in multiple studies. This systematic review included studies that investigated the analytical concordance of immunohistochemistry assays utilizing two or more PD-L1 antibodies from FDA-approved diagnostics for evaluation of PD-L1 expression on tumor or immune cells across a range of tumor types and algorithms.
Methods:
Literature searches were conducted in MEDLINE (via PubMed) and EMBASE to identify studies published between January 1, 2010, and March 31, 2019, that evaluated analytical concordance between two or more assays based on antibodies from FDA-approved assays. Proceedings of key oncology and pathology congresses that took place between January 2016 and March 2019 were searched for abstracts of studies evaluating PD-L1 assay concordance.
Results:
A total of 42 studies across a range of tumor types met the selection criteria. Concordance between 28-8-, 22C3-, and SP263-based assays in lung cancer, urothelial carcinoma, and squamous cell carcinoma of the head and neck was high when used to assess PD-L1 expression on tumor cells (TCs). SP142-based assays had overall low concordance with other approved assays when used to assess PD-L1 expression on TCs. Analytical concordance for assessment of PD-L1 expression on immune cells was variable and generally lower than for PD-L1 expression on TCs.
Conclusion:
A large body of evidence supports the potential interchangeability of 28-8-, 22C3-, and SP263-based assays for the assessment of PD-L1 expression on TCs in lung cancer. Further studies are required in tumor types for which less evidence is available.
Insights
Four US Food and Drug Administration (FDA)-approved programmed death ligand 1 (PD-L1) immunohistochemistry assays show high concordance for tumor cell evaluation in lung cancer. However, concordance varies for immune cell assessment and with the SP142 assay.
Area of Science:
- Oncology
- Immunohistochemistry
- Cancer Biomarkers
Background:
- Four programmed death ligand 1 (PD-L1) immunohistochemistry assays (28-8, 22C3, SP263, SP142) are FDA-approved.
- Analytical concordance between these PD-L1 assays is crucial for consistent cancer immunotherapy patient selection.
Purpose of the Study:
- To systematically review studies evaluating the analytical concordance of FDA-approved PD-L1 immunohistochemistry assays.
- To assess PD-L1 expression on tumor cells (TCs) and immune cells (ICs) across various tumor types.
Main Methods:
- Systematic review of studies published between January 2010 and March 2019.
- Searched MEDLINE (PubMed) and EMBASE databases.
- Searched congress proceedings for abstracts from January 2016 to March 2019.
Main Results:
- 42 studies met selection criteria across diverse tumor types.
- High concordance observed between 28-8, 22C3, and SP263 assays for TC PD-L1 assessment in lung, urothelial, and head and neck cancers.
- SP142 assay showed low concordance with others for TC PD-L1 assessment. Concordance for IC PD-L1 assessment was variable and generally lower than for TCs.
Conclusions:
- Evidence supports interchangeability of 28-8, 22C3, and SP263 assays for TC PD-L1 assessment in lung cancer.
- Further research is needed for other tumor types and for immune cell assessment.
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