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Arch Pathol Lab Med. 2016 Nov;140(11):1259-1266.

Development of a Prototype Immunohistochemistry Assay to Measure Programmed Death Ligand-1 Expression in Tumor Tissue.

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From the Departments of Molecular Biomarkers and Diagnostics (Drs Dolled-Filhart, Pierce, Weiner, Wu, and Emancipator) and Profiling and Expression (Dr Yearley), Merck & Co, Inc, Kenilworth, New Jersey; the Departments of Early Clinical & Translational Research, Clinical Histochemistry (Dr Locke), Research and Clinical Client Services (Dr Murphy), and Operations and Client Services (Dr Lynch), QualTek Molecular Laboratories, Newtown, Pennsylvania; and the Department of Pathology, Eisenhower Medical Center, Rancho Mirage, California (Dr Frisman). Dr Locke is now with Bristol-Myers Squibb, Princeton, New Jersey; Dr Pierce is now with OncoSec Medical, Inc, San Diego, California; Dr Weiner is now with Daiichi Sankyo, Edison, New Jersey; and Dr Wu is currently at Janssen Research & Development, Spring House, Pennsylvania.



- With the abundance of therapeutics targeted against programmed death receptor-1 and its ligand (PD-L1) that are currently approved or in clinical development, there is interest in identifying those patients most likely to respond to these drugs. Expression of PD-L1 may be an indicator of an initial and robust inflammatory response to the presence of tumor cells. Therefore, tumors that express PD-L1 may be the most likely to respond to therapies that interrupt the negative feedback mechanism that leads to PD-L1 upregulation.


- To develop a prototype immunohistochemistry assay using the anti-PD-L1 antibody clone 22C3.


- The assay was developed and optimized using commercially available reagents and archival tumor-bank tissue.


- The optimized immunohistochemistry method had high precision and reproducibility. Using the prototype assay in 142 non-small cell lung cancer and 79 melanoma archival tumor-bank tissue samples, PD-L1 staining was observed at the plasma membrane of nucleated tumor and nontumor cells and, in some cases, as a distinct lichenoid pattern at the tumor-stroma border. Using a preliminary scoring method, 56% (80 of 142) of non-small cell lung cancer and 53% (42 of 79) of melanoma samples were defined as PD-L1+ based on a modified H-score of 1 or more or the presence of a distinctive staining pattern at the tumor-stroma interface.


- The immunohistochemistry assay using the anti-PD-L1 antibody 22C3 merits further investigation in clinical trials and prevalence assessments to further understand the prognostic and predictive value of PD-L1 expression in cancer.

[Indexed for MEDLINE]

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