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PMID: 30173280 Published · ppublish English Journal Article

Predictive potential and need for standardization of PD-L1 immunohistochemistry.

Virchows Archiv : an international journal of pathology ·Vol. 474 ·No. 4 ·2019-04-00 ·Pages 475-484

Savic Prince S, Bubendorf L

Abstract

Checkpoint inhibitors targeting the PD-1/PD-L1 axis are a promising treatment option in several tumor types. PD-L1 expression detected by immunohistochemistry is the first clinically validated predictive biomarker for response to PD-1/PD-L1 inhibitors, though its predictive value varies significantly between tumor types. With the approval of pembrolizumab monotherapy for treatment-naïve, advanced non-small cell lung cancer, PD-L1 testing has to become broadly available in pathology laboratories. When PD-L1 testing started to be introduced in routine pathology practice, there were several open issues, which needed to be addressed in order to provide accurate results. This review will discuss the complex biological background of PD-L1 as predictive biomarker, summarize relevant clinical trials in NSCLC illustrating the origin of different PD-L1 expression cutoffs and scorings, and address issues important for PD-L1 testing including the analytical comparability of the different clinical trial-validated PD-L1 immunohistochemistry assays, the potential of laboratory-developed tests, and an overview of the different scoring algorithms.

Keywords
Immunohistochemistry Immunotherapy PD-L1 Predictive biomarker
MeSH Terms
Antibodies, Monoclonal, Humanized/therapeutic use Antineoplastic Agents, Immunological/therapeutic use B7-H1 Antigen/analysis Biomarkers, Tumor/analysis Carcinoma, Non-Small-Cell Lung/drug therapy Humans Immunohistochemistry/standards Immunotherapy/methods Lung Neoplasms/drug therapy
Chemicals
Antibodies, Monoclonal, Humanized Antineoplastic Agents, Immunological B7-H1 Antigen Biomarkers, Tumor CD274 protein, human pembrolizumab
Authors & Affiliations
2 authors, click to expand affiliations / ORCID
Savic Prince Spasenija
Institute of Pathology, University Hospital Basel, Schönbeinstrasse 40, 4031, Basel, Switzerland. spasenija.savicprince@usb.ch.
Bubendorf Lukas
Institute of Pathology, University Hospital Basel, Schönbeinstrasse 40, 4031, Basel, Switzerland.
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Article Info
Journal
Virchows Archiv : an international journal of pathology
Abbr.
Virchows Arch
ISSN
1432-2307
DOI
10.1007/s00428-018-2445-7
Email
spasenija.savicprince@usb.ch
Published
2019-04-00
Epub
2018-00-01
Pages
475-484
Language
English
Region
Germany
NLM ID
9423843
Subset
IM
External Links
PubMed source DOI: 10.1007/s00428-018-2445-7 View journal details
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