Journal article
Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit
JCO precision oncology, Vol.6, pp.e2200454-e2200454
11/01/2022
DOI: 10.1200/PO.22.00454
PMCID: PMC10530621
PMID: 36446042
Abstract
PURPOSEImmune 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. METHODSTo 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. RESULTSThe 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. CONCLUSIONThe 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.
Details
- Title: Subtitle
- Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit
- Creators
- Daniel F Hayes - University of Michigan Rogel Cancer Center, Ann Arbor, MI.Roy S Herbst - Yale UniversityJonathan L Myles - Cleveland ClinicSuzanne L Topalian - Johns Hopkins UniversitySophia L Yohe - University of MinnesotaNaomi Aronson - Blue Cross Blue Shield AssociationAndrew M Bellizzi - University of IowaUpal Basu RoyGeorganne Bradshaw - College of American PathologistsRobin H Edwards - Bristol-Myers SquibbEhab A El-Gabry - RocheJulia Elvin - Foundation MedicineThomas F Gajewski - University of ChicagoLisa M McShane - National Institutes of HealthMatthew Oberley - Caris Life SciencesReena Philip - United States Food and Drug AdministrationDavid L Rimm - Yale UniversityJason N Rosenbaum - Kaiser PermanenteEric H Rubin - MSDLisa Schlager - Facing Our Risk of Cancer EmpoweredShimere W Sherwood - American Society of Clinical OncologyMark Stewart - Friends of Cancer ResearchJanis M Taube - Johns Hopkins UniversityMagdalena Thurin - National Institutes of HealthPatricia Vasalos - College of American PathologistsJordan Laser - Everly Health, Austin, TX.
- Resource Type
- Journal article
- Publication Details
- JCO precision oncology, Vol.6, pp.e2200454-e2200454
- DOI
- 10.1200/PO.22.00454
- PMID
- 36446042
- PMCID
- PMC10530621
- eISSN
- 2473-4284
- Language
- English
- Date published
- 11/01/2022
- Academic Unit
- Pathology
- Record Identifier
- 9984322059902771
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