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Updated: Aug 27, 2025
Predictive Immune Modeling of Solid Tumors
Published on: February 25, 2020
Molecular Biomarkers of Response to Cancer Immunotherapy
Lauren L Ritterhouse1, Tasos Gogakos1
1Center for Integrated Diagnostics, Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Jackson Building, 10th Floor, Suite 1015, 55 Fruit Street, Boston, MA 02114, USA.
Abstract:
Harnessing the immune system to advance cancer therapy has offered a new weapon in the quiver of clinical oncology. The lack of uniform, robust, or durable responses in many patients has necessitated the development of approaches for the accurate prediction of subgroups that are most likely to benefit from immunotherapy. This has led to the development and regulatory approval of predictive biomarkers, as well as associated companion diagnostics. Despite these strides, there still exists great heterogeneity in the choice of biomarkers, the laboratory assays that generate them, and their overall clinical utility. This article surveys broadly the predictive biomarkers of response to cancer immunotherapy, focusing on the biomarkers with current Food and Drug Administration (FDA) approval, and raising awareness of issues that may affect their broad applicability.
Insights
Predictive biomarkers improve cancer immunotherapy by identifying patients likely to respond. This review covers FDA-approved biomarkers and discusses challenges in their clinical application.
Area of Science:
- Oncology
- Immunology
- Biomarker Discovery
Background:
- Cancer immunotherapy has emerged as a powerful therapeutic strategy.
- Predicting patient response to immunotherapy remains a significant clinical challenge.
- Development of predictive biomarkers is crucial for personalized cancer treatment.
Purpose of the Study:
- To survey predictive biomarkers for cancer immunotherapy response.
- To focus on biomarkers with current Food and Drug Administration (FDA) approval.
- To highlight challenges affecting the broad applicability of these biomarkers.
Main Methods:
- Literature review of predictive biomarkers in cancer immunotherapy.
- Focus on FDA-approved biomarkers and associated companion diagnostics.
- Analysis of heterogeneity in biomarker selection, assays, and clinical utility.
Main Results:
- Several predictive biomarkers have been developed and FDA-approved for immunotherapy.
- Significant heterogeneity exists in biomarker choice, assay methodology, and clinical utility.
- Challenges remain in standardizing and broadly applying these predictive tools.
Conclusions:
- Predictive biomarkers are essential for optimizing cancer immunotherapy.
- Addressing heterogeneity in biomarker development and application is critical.
- Further research is needed to enhance the reliability and accessibility of predictive biomarkers.
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