Review Article
PD-L1 Testing for Lung Cancer in 2019: Perspective From the IASLC Pathology Committee

https://doi.org/10.1016/j.jtho.2019.12.107Get rights and content
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Abstract

The recent development of immune checkpoint inhibitors (ICIs) has led to promising advances in the treatment of patients with NSCLC and SCLC with advanced or metastatic disease. Most ICIs target programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) axis with the aim of restoring antitumor immunity. Multiple clinical trials for ICIs have evaluated a predictive value of PD-L1 protein expression in tumor cells and tumor-infiltrating immune cells (ICs) by immunohistochemistry (IHC), for which different assays with specific IHC platforms were applied. Of those, some PD-L1 IHC assays have been validated for the prescription of the corresponding agent for first- or second-line treatment. However, not all laboratories are equipped with the dedicated platforms, and many laboratories have set up in-house or laboratory-developed tests that are more affordable than the generally expensive clinical trial–validated assays. Although PD-L1 IHC test is now deployed in most pathology laboratories, its appropriate implementation and interpretation are critical as a predictive biomarker and can be challenging owing to the multiple antibody clones and platforms or assays available and given the typically small size of samples provided. Because many articles have been published since the issue of the IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer, this review by the IASLC Pathology Committee provides updates on the indications of ICIs for lung cancer in 2019 and discusses important considerations on preanalytical, analytical, and postanalytical aspects of PD-L1 IHC testing, including specimen type, validation of assays, external quality assurance, and training.

Keywords

PD-L1
Immunohistochemistry
NSCLC
SCLC
Immunotherapy

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Disclosure: Dr. Lantuejoul received advisory board honoraria from AbbVie, AstraZeneca, Bayer, Bristol-Myers Squibb, Merck Sharp and Dohme, Takeda, Roche/Genentech; Dr. Tsao reports grants and personal fees from Merck, AstraZeneca, Pfizer, and Bayer and personal fees from Bristol-Myers Squibb, Hoffmann La Roche, Takeda, Medscape prIME Oncology, outside the submitted work; Dr. Girard reports grants, personal fees, and other from BMS, MSD, Roche, AstraZeneca during the conduct of the study; Dr. Lopez-Rios reports personal fees and nonfinancial support from AbbVie, Bayer, Roche, AstraZeneca, BMS, MSD, Pfizer, Thermo Fisher, and Lilly, outside the submitted work; Dr. Motoi reports grants and personal fees from Ono, Roche Diagnostics and personal fees from Bristol-Myers Squibb, AstraZeneca, Chugai Pharmaceutical, MSD, Agilent, Novartis, Taiho, grants and personal fees from, outside the submitted work; Dr. Kerr reports personal fees from AstraZeneca, Merck Serono, MSD, Ventana, BMS, Null, outside the submitted work; Dr. Yatabe reports personal fees from MDS, Chugai Pharmaceutical, AstraZeneca, Novartis, Pfizer, Roche/Ventana, Agilent/Dako, Thermo Fisher Science, outside the submitted work; Dr. Longshore reports grants from Agilent Technologies, grants and personal fees from Roche Diagnostics, AstraZeneca, Biodesix and personal fees from Bristol-Myers Squibb, Genentech, Merck, Pfizer, AbbVie, Bayer, Loxo Oncology, Spectrum Pharmaceuticals, outside the submitted work, Dr. Papotti reports personal fees from AstraZeneca, Roche, Pfizer, MSD, AbbVie, Novartis, outside the submitted work; Dr. Sholl reports personal fees from AstraZeneca, grants from Roche/ Genentech, outside the submitted work; Dr. Thunnissen reports personal fees from Histogenex, during the conduct of the study; Dr. Borczuk reports personal fees from Bristol-Myers Squibb, outside the submitted work; Dr. Bubendorf reports grants and personal fees from MSD, Roche and personal fees from BMS, AstraZeneca, outside the submitted work; Dr. Beasley reports other from Merck, BMS, Boehringer Ingelheim, Blueprint study, outside the submitted work; Dr. Botling reports grants from Bristol-Myers Squibb, personal fees from Bristol-Myers Squibb, AstraZeneca, MSD, Roche, Pfizer, Boehringer Ingelheim, Novartis, outside the submitted work; Dr. Dacic reports personal fees from Bayer, Takeda, AstraZeneca, outside the submitted work; Dr. Hwang reports personal fees from Pfizer, Roche, Bayer and grants and personal fees from Merck, AstraZeneca, Novartis, Takeda, outside the submitted work; Dr. Nicholson reports personal fees from Merck, Boehringer Ingelheim, and grants and personal fees from Pfizer, Novartis, AstraZeneca, Bristol-Myers Squib, Roche, AstraZeneca, AbbVie, Oncologica, outside the submitted work; Dr. Wistuba reports grants and personal fees from Genentech/ Roche, Asuragen, GlaxoSmithKline, grants and personal fees from AstraZeneca/ Medimmune, Bristol-Myers Squibb, Pfizer, HTG Molecular, Merck, Guardant Health, MSD, grants from DepArray, grants from Bayer, Adaptive, Adaptimmune, EMD Serono, Amgen, Takeda, Johnson & Johnson, Karus, Iovance, Novartis, 4D, Akoya, outside the submitted work; Dr. Mino-Kenudson reports personal fees from H3 Biomedicine, Merrimack Pharmaceuticals, grants from Novartis, outside the submitted work. The remaining authors declare no conflict of interest.