Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies: Guideline From the College of American Pathologists, Association for Molecular Pathology, International Association for the Study of Lung Cancer, Pulmonary Pathology Society, and LUNGevity Foundation
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CONTEXT.—: Rapid advancements in the understanding and manipulation of tumor-immune interactions have led to the approval of immune therapies for patients with non-small cell lung cancer. Certain immune checkpoint inhibitor therapies require the use of companion diagnostics, but methodologic variability has led to uncertainty around test selection and implementation in practice. OBJECTIVE.—: To develop evidence-based guideline recommendations for the testing of immunotherapy/immunomodulatory biomarkers, including programmed death ligand-1 (PD-L1) and tumor mutation burden (TMB), in patients with lung cancer. DESIGN.—: The College of American Pathologists convened a panel of experts in non-small cell lung cancer and biomarker testing to develop evidence-based recommendations in accordance with the standards for trustworthy clinical practice guidelines established by the National Academy of Medicine. A systematic literature review was conducted to address 8 key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, recommendations were created from the available evidence, certainty of that evidence, and key judgments as defined in the GRADE Evidence to Decision framework. RESULTS.—: Six recommendation statements were developed. CONCLUSIONS.—: This guideline summarizes the current understanding and hurdles associated with the use of PD-L1 expression and TMB testing for immune checkpoint inhibitor therapy selection in patients with advanced non-small cell lung cancer and presents evidence-based recommendations for PD-L1 and TMB testing in the clinical setting.
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After selecting patients based on PD-L1 expression, response rates to treatment still vary widely, ranging from 17-49% in patients with Tumor Proportion Score (TPS) > 1%.
“For example, after selecting patients based on PD-L1 expression, response rates to treatment still vary widely, ranging from 17 – 49% in patients with Tumor Proportion Score (TPS) > 1%9.”
From Predicting the tumor microenvironment composition and immunotherapy response in non-small cell lung cancer from digital histopathology images (2024) · cites this paper as [9]
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- Authors
- Sholl, L. M., Awad, M., Basu Roy, U., Beasley, M. B., Cartun, R. W., Hwang, D. M., Kalemkerian, G., Lopez-Rios, F., Mino-Kenudson, M., Paintal, A., Reid, K., Ritterhouse, L., Souter, L. A., Swanson, P. E., Ventura, C. B., & Furtado, L. V.
- Affiliations
- Brigham and Women's Hospital (US)
- Dana-Farber Cancer Institute (US)
- Translational Science Research Program, LUNGevity Foundation, Chicago, Illinois (Basu Roy)
- Mount Sinai Health System (US)
- Hartford Hospital (US)
- Sunnybrook Health Science Centre (CA)
- University of Michigan (US)
- Pathology Department, Hospital Universitario 12 de Octubre, Madrid, Spain (Lopez-Rios)
- Massachusetts General Hospital (US)
- Endeavor Health (US)
- College of American Pathologists (US)
- Foundation Medicine (United States) (US)
- Methodology Consultant, Hamilton, Ontario, Canada (Souter)
- University of Washington Medical Center (US)
- St. Jude Children's Research Hospital (US)
- Corresponding author
- Sholl, Lynette M.
- ORCID
- Venue
- Archives of Pathology & Laboratory Medicine
- Published
- 2024-04-16
- Volume
- 148
- Issue
- 7
- Pages
- 757-774
- ISSN
- 0003-9985 (ISSN-L)
- 1543-2165
- OpenAlex
- W4394853357
- Cited by
- 38
- References
- 8
- Citations by year
- 2026: 12 · 2025: 17 · 2024: 9
- FWCI
- 6.51
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Locations
- Archives of Pathology & Laboratory Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- LUNGevity Foundation
- Association for Molecular Pathology
- Topics
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- PD-L1, tumor mutational burden, non-small cell lung cancer, immune checkpoint inhibitors, companion diagnostics, biomarker testing, immunotherapy selection, PD-L1 expression, advanced lung cancer
- MeSH terms
- Immune Checkpoint Inhibitors, Carcinoma, Non-Small-Cell Lung, Humans, Immunotherapy, Lung Neoplasms, Mutation, Biomarkers, Tumor, B7-H1 Antigen
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