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

Autor:	Hayes DF; University of Michigan Rogel Cancer Center, Ann Arbor, MI., Herbst RS; Yale University, New Haven, CT., Myles JL; The Cleveland Clinic, Cleveland, OH., Topalian SL; Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy, Baltimore, MD., Yohe SL; University of Minnesota, Minneapolis, MN., Aronson N; Blue Cross Blue Shield Association, Chicago, IL., Bellizzi AM; University of Iowa, Iowa City, IA., Basu Roy U; LUNGevity Foundation, Chicago, IL., Bradshaw G; The College of American Pathologists, Northfield, IL., Edwards RH; Bristol-Myers Squibb, New York, NY (at time of summit).; Daiichi Sankyo Inc, Baskin Ridge, NJ., El-Gabry EA; Roche Tissue Diagnostics, Indianapolis, IN.; Akoya Biosciences, Marlborough, MA., Elvin J; Foundation Medicine, Beverly, MA., Gajewski TF; University of Chicago, Chicago, IL., McShane LM; National Institutes of Health/National Cancer Institute, Bethesda, MD., Oberley M; Caris Life Sciences, Phoenix, AZ., Philip R; United States Food and Drug Administration, Silver Spring, MD., Rimm DL; Yale University, New Haven, CT., Rosenbaum JN; Kaiser Permanente Northern California Regional Genetics Laboratory, San Jose, CA., Rubin EH; Merck & Co Inc, Kenilworth, NJ., Schlager L; FORCE: Facing Our Risk of Cancer Empowered, Tampa, FL., Sherwood SW; American Society of Clinical Oncology, Alexandria, VA., Stewart M; Friends of Cancer Research, Washington, DC., Taube JM; Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy, Baltimore, MD., Thurin M; National Institutes of Health/National Cancer Institute, Bethesda, MD., Vasalos P; The College of American Pathologists, Northfield, IL., Laser J; Everly Health, Austin, TX.
Jazyk:	angličtina
Zdroj:	JCO precision oncology [JCO Precis Oncol] 2022 Nov; Vol. 6, pp. e2200454.
DOI:	10.1200/PO.22.00454
Abstrakt:	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.
Databáze:	MEDLINE
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