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The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

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@article{4a8ba87f34864a33b096f4dbe2c5ea8b,
title = "The path to a better biomarker: application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice",
abstract = "Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin-stained slides and have shown reliable inter-reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD-L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immuno-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk-management framework that may help mitigate the risks of suboptimal patient selection for immuno-therapeutic approaches in clinical trials and daily practice based on combined TILs/PD-L1 assessment in BC. {\textcopyright} 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.",
keywords = "B7-H1 Antigen/immunology, Biomarkers, Tumor/immunology, Humans, Lymphocytes, Tumor-Infiltrating/immunology, Risk Management, Triple Negative Breast Neoplasms/immunology",
author = "Gonzalez-Ericsson, {Paula I} and Stovgaard, {Elisabeth S} and Sua, {Luz F} and Emily Reisenbichler and Zuzana Kos and Carter, {Jodi M} and Stefan Michiels and {Le Quesne}, John and Nielsen, {Torsten O} and Anne-Vibeke Laenkholm and Fox, {Stephen B} and Julien Adam and Bartlett, {John Ms} and Rimm, {David L} and Cecily Quinn and Dieter Peeters and Dieci, {Maria V} and Anne Vincent-Salomon and Ian Cree and Hida, {Akira I} and Balko, {Justin M} and Haynes, {Harry R} and Isabel Frahm and Gabriela Acosta-Haab and Marcelo Balancin and Enrique Bellolio and Wentao Yang and Pawan Kirtani and Tomoharu Sugie and Anna Ehinger and Castaneda, {Carlos A} and Marleen Kok and Heather McArthur and Kalliopi Siziopikou and Sunil Badve and Susan Fineberg and Allen Gown and Giuseppe Viale and Schnitt, {Stuart J} and Giancarlo Pruneri and Frederique Penault-Llorca and Stephen Hewitt and Thompson, {E Aubrey} and Allison, {Kimberly H} and Symmans, {William F} and Bellizzi, {Andrew M} and Edi Brogi and Moore, {David A} and Denis Larsimont and Dillon, {Deborah A} and {International Immuno-Oncology Biomarker Working Group}",
note = "{\textcopyright} 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.",
year = "2020",
month = apr,
doi = "10.1002/path.5406",
language = "English",
volume = "250",
pages = "667--684",
journal = "Journal of Pathology",
issn = "0022-3417",
publisher = "John/Wiley & Sons Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - The path to a better biomarker

T2 - application of a risk management framework for the implementation of PD-L1 and TILs as immuno-oncology biomarkers in breast cancer clinical trials and daily practice

AU - Gonzalez-Ericsson, Paula I

AU - Stovgaard, Elisabeth S

AU - Sua, Luz F

AU - Reisenbichler, Emily

AU - Kos, Zuzana

AU - Carter, Jodi M

AU - Michiels, Stefan

AU - Le Quesne, John

AU - Nielsen, Torsten O

AU - Laenkholm, Anne-Vibeke

AU - Fox, Stephen B

AU - Adam, Julien

AU - Bartlett, John Ms

AU - Rimm, David L

AU - Quinn, Cecily

AU - Peeters, Dieter

AU - Dieci, Maria V

AU - Vincent-Salomon, Anne

AU - Cree, Ian

AU - Hida, Akira I

AU - Balko, Justin M

AU - Haynes, Harry R

AU - Frahm, Isabel

AU - Acosta-Haab, Gabriela

AU - Balancin, Marcelo

AU - Bellolio, Enrique

AU - Yang, Wentao

AU - Kirtani, Pawan

AU - Sugie, Tomoharu

AU - Ehinger, Anna

AU - Castaneda, Carlos A

AU - Kok, Marleen

AU - McArthur, Heather

AU - Siziopikou, Kalliopi

AU - Badve, Sunil

AU - Fineberg, Susan

AU - Gown, Allen

AU - Viale, Giuseppe

AU - Schnitt, Stuart J

AU - Pruneri, Giancarlo

AU - Penault-Llorca, Frederique

AU - Hewitt, Stephen

AU - Thompson, E Aubrey

AU - Allison, Kimberly H

AU - Symmans, William F

AU - Bellizzi, Andrew M

AU - Brogi, Edi

AU - Moore, David A

AU - Larsimont, Denis

AU - Dillon, Deborah A

AU - International Immuno-Oncology Biomarker Working Group

N1 - © 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

PY - 2020/4

Y1 - 2020/4

N2 - Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin-stained slides and have shown reliable inter-reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD-L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immuno-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk-management framework that may help mitigate the risks of suboptimal patient selection for immuno-therapeutic approaches in clinical trials and daily practice based on combined TILs/PD-L1 assessment in BC. © 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

AB - Immune checkpoint inhibitor therapies targeting PD-1/PD-L1 are now the standard of care in oncology across several hematologic and solid tumor types, including triple negative breast cancer (TNBC). Patients with metastatic or locally advanced TNBC with PD-L1 expression on immune cells occupying ≥1% of tumor area demonstrated survival benefit with the addition of atezolizumab to nab-paclitaxel. However, concerns regarding variability between immunohistochemical PD-L1 assay performance and inter-reader reproducibility have been raised. High tumor-infiltrating lymphocytes (TILs) have also been associated with response to PD-1/PD-L1 inhibitors in patients with breast cancer (BC). TILs can be easily assessed on hematoxylin and eosin-stained slides and have shown reliable inter-reader reproducibility. As an established prognostic factor in early stage TNBC, TILs are soon anticipated to be reported in daily practice in many pathology laboratories worldwide. Because TILs and PD-L1 are parts of an immunological spectrum in BC, we propose the systematic implementation of combined PD-L1 and TIL analyses as a more comprehensive immuno-oncological biomarker for patient selection for PD-1/PD-L1 inhibition-based therapy in patients with BC. Although practical and regulatory considerations differ by jurisdiction, the pathology community has the responsibility to patients to implement assays that lead to optimal patient selection. We propose herewith a risk-management framework that may help mitigate the risks of suboptimal patient selection for immuno-therapeutic approaches in clinical trials and daily practice based on combined TILs/PD-L1 assessment in BC. © 2020 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd.

KW - B7-H1 Antigen/immunology

KW - Biomarkers, Tumor/immunology

KW - Humans

KW - Lymphocytes, Tumor-Infiltrating/immunology

KW - Risk Management

KW - Triple Negative Breast Neoplasms/immunology

U2 - 10.1002/path.5406

DO - 10.1002/path.5406

M3 - Review

C2 - 32129476

VL - 250

SP - 667

EP - 684

JO - Journal of Pathology

JF - Journal of Pathology

SN - 0022-3417

IS - 5

ER -

ID: 62371884