Biomarker Exploration and the Need for Testing in Non–Small Cell Lung Cancer



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Biomarkers are molecules found within the blood, other bodily fluids, or tissues, that can indicate the presence of certain conditions or diseases.1 In cancer, biomarkers can help determine one’s risk for some types of cancer, assist in cancer diagnosis, or serve as indicators of tumor growth, metastasis, or disease relapse.2,3 Biomarkers can also be used to help guide treatment selection, predict treatment response, or determine whether a treatment is working.

Over the last few decades, biomarkers have become increasingly important for the treatment of lung cancers. Since 2004, over 20 different biomarkers have been identified and linked to the development of lung cancer. Of these, 9 biomarkers are now treatable using FDA-approved targeted therapies and many others are currently under investigation for future drug development.4,5

Biomarker testing plays a critical role in lung cancer to help determine which targeted therapy may be most appropriate for a particular patient. Therefore, it is essential that biomarker testing is conducted in patients with lung cancer early in the treatment process. Updated guidelines from the National Comprehensive Cancer Network recommend that biomarker testing include assessment of EGFR, ALK, KRAS, ROS1, BRAF, NTRK, MET, RET, and HER2 in all patients with advanced or metastatic NSCLC.6 Study data show that less than 60% of patients receive recommended biomarker testing prior to first-line therapy.7 Moreover, testing rates are low among certain ethnic and racial subpopulations, and there remains an ongoing need for improved strategies to overcome barriers and disparities related to biomarker testing.8


  1. Biomarker. Dictionary of Cancer Terms. National Cancer Institute. Accessed March 17, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/biomarker
  2. Biomarker tests and cancer treatment. American Cancer Society. Accessed March 17, 2023. https://www.cancer.org/treatment/understanding-your-diagnosis/tests/biomarker-tests.html
  3. Biomarkers specific to NSCLC. Pfizer.com. Accessed March 17, 2023. https://www.pfizer.com/news/articles/how_biomarkers_can_help_with_lung_cancer_treatment#:~:text =Biomarkers %20are%20used%20to%20help,or%20a%20specific%20immunotherapy%20drug.&text=Ultimately%2C%20precise%20predictive%20biomarker%20testing,is%20needed %20to%20discover%20more
  4. Targeted drug therapy for non-small cell lung cancer. American Cancer Society. Accessed March 17, 2023. https://www.cancer.org/cancer/lung-cancer/treating-non-small-cell/targeted-therapies.html
  5. Targeted drug therapy for lung cancer. American Lung Association. Accessed March 17, 2023. https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/treatment/types-of-treatment/targeted-therapies
  6. National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. NSCLC version 2.2023. Accessed March 17, 2023. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
  7. Hess LM, Krein PM, Haldane D, Han Y, Sireci AN. Biomarker testing for patients with advanced/metastatic nonsquamous NSCLC in the United States of America, 2015 to 2021. JTO Clin Res Rep. 2022;3(6):100336. doi:10.1016/j.jtocrr.2022.100336
  8. Wu N, Ge W, Quek RG, et al. Trends in real-world biomarker testing and overall survival in US patients with advanced non-small-cell lung cancer. Future Oncol. 2023;10.2217/fon-2022-0540. doi:10.2217/fon-2022-0540

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