Cited by 1,635Cancer Immunotherapy and BiomarkersImmunotherapy and Immune ResponsesFerroptosis and cancer prognosis

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Predictive biomarkers for checkpoint inhibitor-based immunotherapy

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Gibney, Geoffrey T, Weiner, Louis M, Atkins, Michael B·2016·The Lancet Oncology

DOI 10.1016/s1470-2045(16)30406-5PMC PMC5702534

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Abstract

The clinical development of checkpoint inhibitor-based immunotherapy has ushered in an exciting era of anticancer therapy. Durable responses can be seen in patients with melanoma and other malignancies. Although monotherapy with PD-1 or PD-L1 agents are typically well tolerated, the risk of immune-related adverse events increases with combination regimens. The development of predictive biomarkers is needed to optimise patient benefit, minimise risk of toxicities, and guide combination approaches. The greatest focus has been on tumour-cell PD-L1 expression. Although PD-L1 positivity enriches for populations with clinical benefit, PD-L1 testing alone is insufficient for patient selection in most malignancies. In this Review, we discuss the status of PD-L1 testing and explore emerging data on new biomarker strategies with tumour-infiltrating lymphocytes, mutational burden, immune gene signatures, and multiplex immunohistochemistry. Future development of an effective predictive biomarker for checkpoint inhibitor-based immunotherapy will integrate multiple approaches for optimal characterisation of the immune tumour microenvironment.

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Authors: Gibney, G. T., Weiner, L. M., & Atkins, M. B.
Affiliations: Georgetown University Medical Center (US)
Corresponding author: Gibney, Geoffrey T
ORCID: Gibney, Geoffrey T
Weiner, Louis M
Atkins, Michael B
Venue: The Lancet Oncology
Publisher: Elsevier BV
Published: 2016-12
Volume: 17
Issue: 12
Pages: e542-e551
ISSN: 1470-2045 (ISSN-L)
DOI: 10.1016/s1470-2045(16)30406-5
PMC: PMC5702534
OpenAlex: W2559382297
Cited by: 1,635
References: 76
Citations by year: 2026: 62 · 2025: 111 · 2024: 161 · 2023: 222 · 2022: 238 · 2021: 229 · 2020: 248 · 2019: 171 · 2018: 109 · 2017: 83
FWCI: 11.76
Type: journal article
Language: en
Open access: green
www.ncbi.nlm.nih.gov
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet Oncology (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Cancer Institute (R01CA050633, P30CA051008)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Ferroptosis and cancer prognosis
Keywords: predictive biomarkers, immune checkpoint inhibitors, PD-1, PD-L1 expression, tumor-infiltrating lymphocytes, tumor mutational burden, immune-related gene signature, multiplex immunohistochemistry, immune-related adverse events, patient selection, melanoma
MeSH terms: Humans, Immunohistochemistry, Immunotherapy, Neoplasms, Biomarkers, Lymphocytes, Tumor-Infiltrating, Tumor Microenvironment, Cell Cycle Checkpoints, B7-H1 Antigen

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