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

Author:

Hayes Daniel F.1ORCID,Herbst Roy S.2ORCID,Myles Jonathan L.3ORCID,Topalian Suzanne L.4ORCID,Yohe Sophia L.5ORCID,Aronson Naomi6ORCID,Bellizzi Andrew M.7,Basu Roy Upal8,Bradshaw Georganne9,Edwards Robin H.1011,El-Gabry Ehab A.1213,Elvin Julia14ORCID,Gajewski Thomas F.15ORCID,McShane Lisa M.16ORCID,Oberley Matthew17,Philip Reena18,Rimm David L.2ORCID,Rosenbaum Jason N.19ORCID,Rubin Eric H.20,Schlager Lisa21ORCID,Sherwood Shimere W.22,Stewart Mark23ORCID,Taube Janis M.4,Thurin Magdalena16,Vasalos Patricia9,Laser Jordan24

Affiliation:

1. University of Michigan Rogel Cancer Center, Ann Arbor, MI

2. Yale University, New Haven, CT

3. The Cleveland Clinic, Cleveland, OH

4. Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy, Baltimore, MD

5. University of Minnesota, Minneapolis, MN

6. Blue Cross Blue Shield Association, Chicago, IL

7. University of Iowa, Iowa City, IA

8. LUNGevity Foundation, Chicago, IL

9. The College of American Pathologists, Northfield, IL

10. Bristol-Myers Squibb, New York, NY (at time of summit)

11. Daiichi Sankyo Inc, Baskin Ridge, NJ

12. Roche Tissue Diagnostics, Indianapolis, IN

13. Akoya Biosciences, Marlborough, MA

14. Foundation Medicine, Beverly, MA

15. University of Chicago, Chicago, IL

16. National Institutes of Health/National Cancer Institute, Bethesda, MD

17. Caris Life Sciences, Phoenix, AZ

18. United States Food and Drug Administration, Silver Spring, MD

19. Kaiser Permanente Northern California Regional Genetics Laboratory, San Jose, CA

20. Merck & Co Inc, Kenilworth, NJ

21. FORCE: Facing Our Risk of Cancer Empowered, Tampa, FL

22. American Society of Clinical Oncology, Alexandria, VA

23. Friends of Cancer Research, Washington, DC

24. Everly Health, Austin, TX

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Reference88 articles.

1. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline

2. ASCO/CAP Immune Checkpoint Inhibitor (ICI) Predictive Factor Virtual Summit. https://www.cap.org/member-resources/precision-medicine/ici-predictive-factor-virtual-summit

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