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Predictive biomarkers for checkpoint inhibitor-based immunotherapy
Open accessAbstract
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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“Currently, there is no reliable biomarker for predicting BLCA immunotherapy efficiency.”
From TBX3 shapes an immunosuppressive microenvironment and induces immunotherapy resistance (2025) · cites this paper as [56]
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Metadata
- Authors
- Gibney, G. T., Weiner, L. M., & Atkins, M. B.
- Affiliations
- Georgetown University Medical Center (US)
- Corresponding author
- Gibney, Geoffrey T
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2016-12
- Volume
- 17
- Issue
- 12
- Pages
- e542-e551
- ISSN
- 1470-2045 (ISSN-L)
- 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
- 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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