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Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit
Daniel F Hayes1, Roy S Herbst2, Jonathan L Myles3
1University of Michigan Rogel Cancer Center, Ann Arbor, MI.
Purpose:
Immune checkpoint inhibition (ICI) therapy represents one of the great advances in the field of oncology, highlighted by the Nobel Prize in 2018. Multiple predictive biomarkers for ICI benefit have been proposed. These include assessment of programmed death ligand-1 expression by immunohistochemistry, and determination of mutational genotype (microsatellite instability or mismatch repair deficiency or tumor mutational burden) as a reflection of neoantigen expression. However, deployment of these assays has been challenging for oncologists and pathologists alike.
Methods:
To address these issues, ASCO and the College of American Pathologists convened a virtual Predictive Factor Summit from September 14 to 15, 2021. Representatives from the academic community, US Food and Drug Administration, Centers for Medicare and Medicaid Services, National Institutes of Health, health insurance organizations, pharmaceutical companies, in vitro diagnostics manufacturers, and patient advocate organizations presented state-of-the-art predictive factors for ICI, associated problems, and possible solutions.
Results:
The Summit provided an overview of the challenges and opportunities for improvement in assay execution, interpretation, and clinical applications of programmed death ligand-1, microsatellite instability-high or mismatch repair deficient, and tumor mutational burden-high for ICI therapies, as well as issues related to regulation, reimbursement, and next-generation ICI biomarker development.
Conclusion:
The Summit concluded with a plan to generate a joint ASCO/College of American Pathologists strategy for consideration of future research in each of these areas to improve tumor biomarker tests for ICI therapy.
Insights
Challenges in using biomarkers like programmed death ligand-1 and tumor mutational burden for immune checkpoint inhibition (ICI) therapy led to a summit. Experts proposed strategies to improve these predictive tests for better cancer treatment outcomes.
Area of Science:
- Oncology
- Biomarker Discovery
- Cancer Therapeutics
Background:
- Immune checkpoint inhibition (ICI) therapy is a significant advancement in oncology, with biomarkers like programmed death ligand-1 (PD-L1) expression and tumor mutational burden (TMB) proposed to predict treatment benefit.
- Challenges exist in the clinical deployment and interpretation of these predictive assays, hindering widespread oncologist and pathologist adoption.
Purpose of the Study:
- To address the challenges in predictive biomarker assays for ICI therapies.
- To foster collaboration among stakeholders to improve the clinical utility of biomarkers.
Main Methods:
- Convened a virtual Predictive Factor Summit with diverse stakeholders including academic, regulatory, industry, and patient representatives.
- Facilitated discussions on state-of-the-art predictive factors, associated problems, and potential solutions for ICI therapy.
Main Results:
- Identified challenges and opportunities in assay execution, interpretation, and clinical application of PD-L1, microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), and TMB-high biomarkers.
- Addressed issues concerning regulation, reimbursement, and the development of next-generation ICI biomarkers.
Conclusions:
- A joint strategy between ASCO and the College of American Pathologists will be developed.
- Future research will focus on improving tumor biomarker tests for ICI therapy to enhance patient outcomes.
