Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit

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.