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Clin Cancer Res. 2017 Sep 1;23(17):4970-4979. doi: 10.1158/1078-0432.CCR-16-3063.

The Challenge for Development of Valuable Immuno-oncology Biomarkers.

Author information

1
Rutgers Cancer Institute of New Jersey, Rutgers University, New Brunswick, New Jersey. mehnerja@cinj.rutgers.edu.
2
Rutgers Robert Wood Johnson Medical School, Rutgers University, New Brunswick, New Jersey.
3
UC Davis Comprehensive Cancer Center, Sacramento, California.
4
Patient Advocates In Research (PAIR), Danville, California.
5
National Cancer Institute, Bethesda, Maryland.
6
National Cancer Institute, Rockville, Maryland.

Abstract

The development of immunotherapy is an important breakthrough for the treatment of cancer, with antitumor efficacy observed in a wide variety of tumors. To optimize immunotherapy use, approaches must be developed to identify which patients are likely to achieve benefit. To minimize therapeutic toxicities and costs, understanding the ideal choice and sequencing of the numerous immuno-oncology agents available for individual patients is thus critical, but fraught with challenges. The immune tumor microenvironment (TME) is a unique aspect of the response to immuno-oncology agents and measurement of single biomarkers does not adequately capture these complex interactions. Therefore, multiple potential biomarkers are likely needed. Current candidates in this area include PD-L1 expression, CD8+ tumor-infiltrating lymphocytes, tumor mutation load and neoantigen burden, immune-related gene signatures, and multiplex IHC assays that examine the pharmacodynamic and spatial interactions of the TME. The most fruitful investigations are likely to use several techniques to predict response and interrogate mechanisms of resistance. Immuno-oncology biomarker research must employ validated assays to ask focused research questions utilizing clinically annotated tissue collections and biomarker-focused clinical trial designs to investigate specific endpoints. Real-time input from patients and their advocates into biomarker discovery is necessary to ensure that the investigations pursued will improve both clinical outcomes and quality of life. We herein provide a framework of recommendations to guide the search for immuno-oncology biomarkers of value.

PMID:
28864725
PMCID:
PMC5657536
DOI:
10.1158/1078-0432.CCR-16-3063
[Indexed for MEDLINE]
Free PMC Article

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