Development of an automated PD-L1 immunohistochemistry (IHC) assay for non-small cell lung cancer

Applied Immunohistochemistry & Molecular Morphology : AIMM
Therese PhillipsXiaoling Zhang

Abstract

Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune checkpoint inhibitor antibody, developed by Bristol-Myers Squibb Inc., has activity across non-small cell lung cancer (NSCLC) histologies and is Food and Drug Administration approved for treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy. PD-L1 has been investigated as a potential biomarker to predict clinical response to nivolumab in clinical settings. We report an automated PD-L1 immunohistochemistry (IHC) assay, which was developed to detect cell surface PD-L1 in formalin-fixed paraffin-embedded human tumor tissue specimens using Dako's Autostainer Link 48. The primary antibody for this assay is a rabbit monoclonal anti-human PD-L1 antibody, clone 28-8. The specificity of 28-8 for PD-L1 was demonstrated by antigen competition and genetic deletion of PD-L1 in tumor cell lines. The specificity of the PD-L1 IHC assay was further evaluated in a collection of 30 normal human tissues. The PD-L1 IHC assay was optimized for high sensitivity and precision in routine application. A pathology scoring and interpretation method specific to nivolumab clinical studies was adopted for the assay. The analytical performance of the assay...Continue Reading

References

Jan 23, 2003·The Journal of Immunology : Official Journal of the American Association of Immunologists·Julia A BrownGordon J Freeman
Aug 7, 2004·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Jun KonishiMasaharu Nishimura
Dec 24, 2010·Nature Biotechnology·Jeffrey C MillerEdward J Rebar
Jun 5, 2012·The New England Journal of Medicine·Suzanne L TopalianMario Sznol
Aug 8, 2012·Clinical Lung Cancer·Jennifer M BolandMarie Christine Aubry
Nov 13, 2013·Laboratory Investigation; a Journal of Technical Methods and Pathology·Vamsidhar VelchetiDavid L Rimm
Apr 10, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Janis M TaubeRobert A Anders
Nov 18, 2014·The New England Journal of Medicine·Caroline RobertPaolo A Ascierto

❮ Previous
Next ❯

Citations

Jan 19, 2016·Annales de pathologie·Julien AdamSylvie Lantuéjoul
Oct 22, 2015·Annals of Oncology : Official Journal of the European Society for Medical Oncology·Torsten GoldmannMartin Reck
Jan 13, 2016·Archives of Pathology & Laboratory Medicine·Keith M Kerr, Fred R Hirsch
Apr 28, 2016·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Hui YuFred R Hirsch
Aug 10, 2016·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J F NovotnyS Averbuch
Oct 25, 2016·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Hui YuFred R Hirsch
May 19, 2017·Journal of Hematology & Oncology·Delong LiuWendy Bindeman
Dec 7, 2016·Applied Immunohistochemistry & Molecular Morphology : AIMM·Hadi Yaziji, Clive R Taylor
Dec 4, 2016·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Fred R HirschKeith M Kerr
Jan 20, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·J AdamS Lantuéjoul
Feb 27, 2018·Expert Review of Clinical Pharmacology·Maria Rita GaiserIsaac Brownell
Sep 4, 2016·The Journal of Histochemistry and Cytochemistry : Official Journal of the Histochemistry Society·Brandon S SheffieldDiana N Ionescu
Dec 1, 2017·Applied Immunohistochemistry & Molecular Morphology : AIMM·Therese PhillipsHenrik Winther
Apr 3, 2018·Archives of Pathology & Laboratory Medicine·Kelly A SchatsMark M Kockx
Oct 31, 2017·Applied Immunohistochemistry & Molecular Morphology : AIMM·Isaac E LloydBarbara E Chadwick
Jan 19, 2018·Applied Immunohistochemistry & Molecular Morphology : AIMM·Bharathi VennapusaZachary Boyd
Feb 15, 2018·Targeted Oncology·Jeffrey M ClarkeApril K S Salama
Mar 12, 2019·The International Journal of Biological Markers·Young San Ko, Jung-Soo Pyo
Sep 6, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·R Wendel NaumannKathleen N Moore
Nov 22, 2018·Journal for Immunotherapy of Cancer·Francesco SabbatinoStefano Pepe
Oct 5, 2019·Journal of Clinical Medicine·Carlo GenovaFrancesco Grossi
Jun 30, 2016·The Oncologist·Leora HornDavid R Spigel
Oct 5, 2019·Applied Immunohistochemistry & Molecular Morphology : AIMM·Carol C CheungUNKNOWN Canadian Association of Pathologists-Association Canadienne Des Pathologistes’ National Standards Committee for High Complex
Oct 28, 2019·Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia·Vladimir ZidlikSvetlana Brychtova
Jan 7, 2017·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Emeka K EnwereCorinne M Doll
Mar 24, 2017·Biomarker Research·Laurence P Diggs, Eddy C Hsueh

❮ Previous
Next ❯

Methods Mentioned

BETA
fluorescence assay
PCR
Fluorescence-Activated Cell Sorter
FACS
Assay
biopsies
biopsy

Related Concepts

Related Feeds

Cancer Genomics (Keystone)

Cancer genomics approaches employ high-throughput technologies to identify the complete catalog of somatic alterations that characterize the genome, transcriptome and epigenome of cohorts of tumor samples. Discover the latest research using such technologies in this feed.