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Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
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The Cancer Immunotherapy Biomarker Testing Landscape.

Eric E Walk1, Sophia L Yohe1, Amy Beckman1

  • 1From the Department of Medical & Scientific Affairs, Roche Tissue Diagnostics, Tucson, Arizona (Dr Walk); the Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis (Drs Yohe and Beckman); Diagnostic and Experimental Pathology, Eli Lilly and Company, Indianapolis, Indiana (Dr Schade); the Department of Pathology, Microbiology, and Immunology, Vanderbilt University School of Medicine, Nashville, Tennessee (Dr Zutter); the Department of Molecular Pathology and Genomics, Swedish Cancer Institute, Seattle, Washington (Dr Berry); and the Department of Pathology, Washington University School of Medicine, St Louis, Missouri (Dr Pfeifer).

Archives of Pathology & Laboratory Medicine
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Predicting cancer immunotherapy response requires better biomarkers. While programmed death ligand-1 (PD-L1), mismatch repair, and microsatellite instability tests guide current therapies, new biomarkers are crucial for personalized cancer treatment.

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Area of Science:

  • Oncology
  • Immunology
  • Pathology

Background:

  • Cancer immunotherapy offers significant clinical benefits for advanced cancers.
  • Accurate biomarkers are essential for predicting patient response to immunotherapy.
  • Current validated biomarkers include PD-L1, mismatch repair, and microsatellite instability.

Purpose of the Study:

  • To update pathologists on cancer immunotherapy testing.
  • To review the scientific background, clinical data, and testing methods for key biomarkers.
  • To discuss emerging biomarkers and their clinical relevance.

Main Methods:

  • Review of scientific publications and clinical trial data.
  • Analysis of programmed death ligand-1 (PD-L1) testing.
  • Evaluation of mismatch repair (MMR) and microsatellite instability (MSI) assays.

Main Results:

  • PD-L1, MMR, and MSI testing aid in guiding FDA-approved immunotherapies.
  • There is an ongoing need for improved predictors of response and resistance.
  • Emerging biomarkers include tumor mutational burden, neoantigens, and immune cell infiltrates.

Conclusions:

  • The field of cancer immunotherapy and biomarker testing is rapidly evolving.
  • Pathologists play a vital role in translational research and implementing new diagnostics.
  • Next-generation biomarkers are expected to enhance personalized cancer treatment strategies.