Overview
Immunotherapies, such as immune checkpoint inhibitors (ICIs), are revolutionizing cancer treatment, but they only work in some patients. Identifying biomarkers for immunotherapies such as ICIs is an important goal to avoid suboptimal treatment response and unnecessary adverse events. Predictive and prognostic biomarkers are needed to help identify patients who may respond to treatment, to monitor treatment outcomes, and to improve the safety and efficacy of immunotherapies themselves.
Clinically Relevant Biomarkers
Clinically relevant biomarkers to predict response to ICIs include Programmed death-ligand 1 (PD-L1) expression, Tumor Mutational Burden (TMB), and Microsatellite Instability/Mismatch Repair Deficiency (MSI-H/dMMR). In addition, circulating tumor DNA (ctDNA) is useful for monitoring the response to ICIs in patients undergoing therapy.
Important Topics of Interest for Healthcare Providers
Key topics of interest for healthcare providers include: understanding the role of individual biomarkers and how biomarkers are used in clinical practice; interpreting biomarker results; how biomarkers guide immunotherapy decisions; and limitations of biomarkers. In addition, it is important for healthcare providers to be able to explain what biomarkers are to patients, including their limitations, and how response to immunotherapy is variable.
Suggested Resources
This page includes links to information on known and emerging biomarkers that is relevant for healthcare providers who prescribe or who are interested in optimizing outcomes with cancer immunotherapies.
AIM with Immunotherapy ctDNA Testing Page
Checkpoint Inhibitor Response Monitoring:Â Timely Guidance Using ctDNA
https://aimwithimmunotherapy.org/provider-resources/other-resources/ctdna-testing-for-response-monitoring/
AIM with Immunotherapy Biomarker Articles
Potential Biomarker May Indicate T-VEC Efficacy
https://aimwithimmunotherapy.org/uncategorized/potential-biomarker-may-indicate-t-vec-efficacy/
Genetics Define Biomarkers of Response to Immunotherapy
https://aimwithimmunotherapy.org/uncategorized/genetics-define-biomarkers-of-response-to-immunotherapy/
Recent Guidelines and Publications on Biomarkers
Society for Immunotherapy of Cancer (SITC) consensus statement on essential biomarkers for immunotherapy clinical protocols
https://pubmed.ncbi.nlm.nih.gov/40054999/
Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers: ASCO Guideline
https://ascopubs.org/doi/10.1200/JCO.22.02328
Precision Immunotherapy for Head and Neck Cancer: Therapeutic Combinations, Biomarker Strategies, and Translational Challenges
https://pubmed.ncbi.nlm.nih.gov/41851770/
Advances in Systemic Therapy for Lung Cancer: Update on Biomarkers and Novel Drugs for Patients with Stage IV Non-Small Cell Lung Cancer (NSCLC)
https://pubmed.ncbi.nlm.nih.gov/41260733/