TY - JOUR
T1 - Fit-For-Purpose PD-L1 Biomarker Testing for Patient Selection in Immuno-Oncology
T2 - Guidelines for Clinical Laboratories from the Canadian Association of Pathologists-Association Canadienne des Pathologistes (CAP-ACP)
AU - Canadian Association of Pathologists-Association Canadienne Des Pathologistes' National Standards Committee for High Complexity Testing (CAP-ACP NSCHCT)
AU - Cheung, Carol C.
AU - Barnes, Penny
AU - Bigras, Gilbert
AU - Boerner, Scott
AU - Butany, Jagdish
AU - Calabrese, Fiorella
AU - Couture, Christian
AU - Deschenes, Jean
AU - El-Zimaity, Hala
AU - Fischer, Gabor
AU - Fiset, Pierre O.
AU - Garratt, John
AU - Geldenhuys, Laurette
AU - Gilks, C. Blake
AU - Ilie, Marius
AU - Ionescu, Diana
AU - Lim, Hyun J.
AU - Manning, Lisa
AU - Mansoor, Adnan
AU - Riddell, Robert
AU - Ross, Catherine
AU - Roy-Chowdhuri, Sinchita
AU - Spatz, Alan
AU - Swanson, Paul E.
AU - Tron, Victor A.
AU - Tsao, Ming Sound
AU - Wang, Hangjun
AU - Xu, Zhaolin
AU - Torlakovic, Emina E.
N1 - Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Since 2014, programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immuno-oncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.
AB - Since 2014, programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immuno-oncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.
KW - PD-L1
KW - biomarker
KW - guidelines
KW - immunotherapy
KW - quality assurance
UR - http://www.scopus.com/inward/record.url?scp=85073446454&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85073446454&partnerID=8YFLogxK
U2 - 10.1097/PAI.0000000000000800
DO - 10.1097/PAI.0000000000000800
M3 - Review article
C2 - 31584451
AN - SCOPUS:85073446454
SN - 1541-2016
VL - 27
SP - 699
EP - 714
JO - Applied Immunohistochemistry and Molecular Morphology
JF - Applied Immunohistochemistry and Molecular Morphology
IS - 10
ER -