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Review ArticleReview

Biomarkers for Predicting Response to Immunotherapy with Immune Checkpoint Inhibitors in Cancer Patients

Michael J. Duffy, John Crown
DOI: 10.1373/clinchem.2019.303644 Published September 2019
Michael J. Duffy
Clinical Research Centre, St. Vincent's University Hospital, Dublin, Ireland; UCD School of Medicine, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Dublin, Ireland;
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  • For correspondence: michael.j.duffy@ucd.ie
John Crown
Medical Oncology Department, St. Vincent's University Hospital, Dublin, Ireland.
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Abstract

BACKGROUND: Immunotherapy, especially the use of immune checkpoint inhibitors, has revolutionized the management of several different cancer types in recent years. However, for most types of cancer, only a minority of patients experience a durable response. Furthermore, administration of immunotherapy can result in serious adverse reactions. Thus, for the most efficient and effective use of immunotherapy, accurate predictive biomarkers that have undergone analytical and clinical validation are necessary.

CONTENT: Among the most widely investigated predictive biomarkers for immunotherapy are programmed death-ligand 1 (PD-L1), microsatellite instability/defective mismatch repair (MSI/dMMR), and tumor mutational burden (TMB). MSI/dMMR is approved for clinical use irrespective of the tumor type, whereas PD-L1 is approved only for use in certain cancer types (e.g., for predicting response to first-line pembrolizumab monotherapy in non-small cell lung cancer). Although not yet approved for clinical use, TMB has been shown to predict response to several different forms of immunotherapy and across multiple cancer types. Less widely investigated predictive biomarkers for immunotherapy include tumor-infiltrating CD8+ lymphocytes and specific gene signatures. Despite being widely investigated, assays for MSI/dMMR, PD-L1, and TMB lack standardization and are still evolving. An urgent focus of future research should be the optimization and standardization of method for determining these biomarkers.

SUMMARY: Biomarkers for predicting response to immunotherapy are paving the way for personalized treatment for patients with diverse cancer types. However, standardization of the available biomarker assays is an urgent requirement.

  • Received for publication February 27, 2019.
  • Accepted for publication May 23, 2019.
  • © 2019 American Association for Clinical Chemistry
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Clinical Chemistry: 65 (10)
Vol. 65, Issue 10
October 2019
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Biomarkers for Predicting Response to Immunotherapy with Immune Checkpoint Inhibitors in Cancer Patients
Michael J. Duffy, John Crown
Clinical Chemistry Oct 2019, 65 (10) 1228-1238; DOI: 10.1373/clinchem.2019.303644
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Biomarkers for Predicting Response to Immunotherapy with Immune Checkpoint Inhibitors in Cancer Patients
Michael J. Duffy, John Crown
Clinical Chemistry Oct 2019, 65 (10) 1228-1238; DOI: 10.1373/clinchem.2019.303644

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