Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies

Publication Date: April 16, 2024
Last Updated: April 19, 2024

Summary of Recommendations

In patients with advanced non–small cell lung cancer, pathologists should use a validated PD-L1 immunohistochemistry expression assay, in conjunction with other targetable genomic biomarker assays where appropriate, to optimize selection for treatment with immune checkpoint inhibitors. (S, M )
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Pathologists should ensure appropriate validation has been performed on all specimen types and fixatives. (C, L )
Note: Specific validation requirements are out of scope with this guideline, and laboratories should refer to the Principles of Analytic Validation of Immunohistochemical Assays Guideline for details on how to validate IHC specimens.
620
When feasible, pathologists should use clinically validated PD-L1 immunohistochemistry assays as intended. (C, VL )
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Pathologists who choose to use laboratory-developed tests for PD-L1 expression should validate according to the requirements of their accrediting body. (S, VL )
620
Pathologists should report PD-L1 immunohistochemistry results using a percentage expression score. (C, VL )
620
Clinicians should not use tumor mutation burden alone to select patients with advanced NSCLC for immune checkpoint inhibitors, based on insufficient evidence in this population. (C, VL )
620

Recommendation Grading

Disclaimer

The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

Overview

Title

Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies

Authoring Organizations

Publication Month/Year

April 16, 2024

Last Updated Month/Year

May 1, 2024

Supplemental Implementation Tools

Document Type

Guideline

Country of Publication

US

Document Objectives

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.

Inclusion Criteria

Male, Female, Adolescent, Adult, Child, Older adult

Health Care Settings

Ambulatory, Laboratory services, Outpatient

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Assessment and screening, Management

Diseases/Conditions (MeSH)

D002289 - Carcinoma, Non-Small-Cell Lung, D061026 - Programmed Cell Death 1 Receptor

Keywords

lung cancer, immune checkpoint inhibitor (ICI), Immune Checkpoint Inhibitor, Cancer immunotherapy, small cell lung cancer immunotherapy, PDL1, Checkpoint Inhibitor Therapies

Source Citation

Sholl LM, Awad M, Basu Roy U, Beasley MB, Cartun RW, Hwang DM, Kalemkerian G, Lopez-Rios F, Mino-Kenudson M, Paintal A, Reid K, Ritterhouse L, Souter LA, Swanson PE, Ventura CB, Furtado LV. 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. Arch Pathol Lab Med. 2024 Apr 16. doi: 10.5858/arpa.2023-0536-CP. Epub ahead of print. PMID: 38625026.

Supplemental Methodology Resources

Data Supplement, Data Supplement

Methodology

Number of Source Documents
175
Literature Search Start Date
October 16, 2019
Literature Search End Date
May 13, 2022