Before selecting a first-line therapy for a patient with NSCLC, it’s important to have all the information you need to make an informed decision. This includes waiting for all biomarker test results—in addition to PD-L1.
of patients have oncogenic drivers—and of these patients, about 2 in 3 have an actionable biomarker1-5*
*Regardless of PD-L1 expression.
Studies are currently evaluating the utility of targeting biomarkers in earlier stages of NSCLC.10-12
Optimize testing practices to inform appropriate treatment plans
In mNSCLC, the NCCN Guidelines® recommend9:
Molecular testing be performed (when feasible) via a broad panel-based approach, typically by next-generation sequencing (NGS)
Upfront PD-L1 expression testing before first-line therapy
Patients, across all PD-L1 expression levels, are negative for actionable molecular markers before utilizing IO as a first-line treatment option†
In eNSCLC, the NCCN Guidelines recommend biomarker testing for9:
PD-L1 expression in resectable stage II-IIIA NSCLC
EGFR mutations in resectable stage IB-IIIA NSCLC
† | The NCCN Guidelines for NSCLC provide recommendations for certain individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays or commercial laboratories. |
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. | |
Please see the latest version of the NCCN Guidelines for the most up-to-date and detailed recommendations. |
IASLC Guidelines21
Liquid biopsy is considered an accurate, reliable, and complementary approach for genotyping of newly diagnosed patients with mNSCLC, and it should be performed using a clinically validated NGS platform‡
NCCN Guidelines9
Liquid biopsy (plasma ctDNA testing) can be considered for eligible patients with mNSCLC when there is limited tissue availability or the patient is unfit for invasive tissue sampling
Liquid biopsy may overcome some of the limitations of tumor tissue genotyping due to a faster turnaround time and a less invasive procedure21
‡ | Liquid biopsy can be considered a preferred method of molecular testing in some clinical settings and complementary to tumor tissue testing in others.21 |
Want to learn more?
Not only can identifying gene alterations inform which targeted therapies might be right for each patient, it also can help determine which therapies to avoid due to a potential lack of clinical benefit.9 NGS can assess most actionable biomarkers with one test—so you can identify if a biomarker is responsible for driving disease.22
By using a broad panel-based approach, like NGS, you could improve the overall patient experience and make biomarker testing more efficient compared with sequential single-gene testing.23
Account for multiple
biomarkers with one test
Fewer rebiopsies and
complications
Shorter time-to-test
results
Lower costs to
healthcare system
This was based on a study that used a decision tree analytic modeling approach and budget impact analysis assuming a hypothetical health plan covering 1 million members. Model inputs and assumptions may contain uncertainty or have limited generalizability. The time-to-results shown below are variable and subject to the type of tests ordered and the laboratories used.23
Know more about the potential benefits of comprehensive biomarker testing
This analysis consisted of a hypothetical 1-million-member health plan with 2,066 Medicare-insured patients and 156 commercially insured patients estimated to have mNSCLC and be eligible for testing. Biomarker testing costs were included, but the costs and benefits of therapy were excluded.23
~$700
cost savings per
Medicare-insured patient
~$800
cost savings per
commercially insured patient
Cost savings for testing in eNSCLC are not yet available.
|| | This study consists of a modeling approach using a decision tree and budget impact framework. The model inputs and assumptions—some of which were based on opinions—may have limited generalizability or contain uncertainty. A robust analysis of accurate real-life numbers would be required before making any definitive conclusions. However, model results stayed robust in sensitivity analyses. |
¶ | The reimbursement amount for testing was estimated based off of publicly available CMS information or commercial claims. Consequently, the results may not be generalizable beyond the studied payers. |
# | The per-patient cost of sequential testing was considered to be the total cost of each individual test for PD-L1 and alterations with or without FDA-approved therapies—EGFR, ALK, ROS1, BRAF, MET, HER2, RET, NTRK1, and KRAS—multiplied by the amount of patients who received each test, which was determined by the results for the preceding testing and rebiopsy rate. |
** | The cost of the NGS testing strategy was the total cost of the PD-L1 test and NGS. |
†† | Plan–total testing costs were estimated assuming all patients with mNSCLC were tested using only one strategy. |
‡‡ | Costs were reported in 2017 US dollars. |
The Centers for Medicare & Medicaid Services has determined that NGS as a diagnostic laboratory test is reasonable and necessary and covered nationally when performed in a CLIA-certified laboratory and all of the following requirements are met26:
§§ Diagnostic coverage may vary across payers.
ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; CLIA=Clinical Laboratory Improvement Amendments; CMS=Centers for Medicare & Medicaid Services; ctDNA=circulating tumor DNA; EGFR=epidermal growth factor receptor; FISH=fluorescence in situ hybridization; HER2=human epidermal growth factor receptor 2; IASLC=International Association for the Study of Lung Cancer; IHC=immunohistochemistry; KRAS=Kirsten rat sarcoma; MET=MET proto-oncogene; NCCN=National Comprehensive Cancer Network®; NTRK1/2/3=neurotrophic tyrosine kinase receptor types 1, 2, and 3; PCR=polymerase chain reaction; PD-L1=programmed death-ligand 1; QNS=quantity not sufficient; RET=rearranged during transfection; ROS1=ROS proto-oncogene 1.
References: 1. Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: current therapies and new targeted treatments. Lancet. 2017;389(10066):299-311. 2. VanderLaan PA, Rangachari D, Costa DB. The rapidly evolving landscape of biomarker testing in non-small cell lung cancer. Cancer Cytopathol. 2021;129(3):179-181. 3. US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc. Accessed July 7, 2022. 4. König D, Prince SS, Rothschild SI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers (Basel). 2021;13(4):804. 5. Peters S, Reck M, Smit EF, Mok T, Hellmann MD. How to make the best use of immunotherapy as first-line treatment of advanced/metastatic non-small-cell lung cancer. Ann Oncol. 2019;30:884-896. 6. Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993. 7. Skov B, Rørvig SB, Lindkær TH, et al. The prevalence of programmed death-ligand-1 (PD-L1) expression in non-small cell lung cancer in an unselected, consecutive population. Mod Pathol. 2020;33(1):109-117. 8. Russo A, Lopes AR, McCusker MG, et al. New targets in lung cancer (excluding EGFR, ALK, ROS1). Curr Oncol Rep. 2020;22(5):48. 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 23, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. 10. Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017;6(2):196-211. 11. Sandler JE, D’Aiello A, Halmos B. Changes in store for early-stage non-small cell lung cancer. J Thorac Dis. 2019;11(5):2117-2125. 12. Yi C, He Y, Xia H, Zhang P. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC. Onco Targets Ther. 2019;12:7329-7336. 13. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006. 14. Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016;387(10026):1415-1426. 15. Solomon BJ, Kim DW, Wu YL, et al. J Clin Oncol. 2018;36(22):2251-2258. 16. Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities. Clin Lung Cancer. 2017;18(6):651-659. 17. Offin M, Guo R, Wu SL, et al. lmmunophenotype and response to immunotherapy of RET-rearranged lung cancers. JCO Precis Oncol. 2019;3:PO.18.00386. 18. Lisberg A, Cummings A, Goldman JW, et al. J Thorac Oncol. 2018;13(8):1138-1145. 19. Lin JJ, Chin E, Yeap BY, et al. J Thorac Oncol. 2018;14(1):135-140. 20. Schoenfeld AJ, Arbour KC, Rizvi H, et al. Ann Oncol. 2019;30(5):839-844. 21. Rolfo C, Mack P, Scagliotti GV, et al. Liquid biopsy for advanced NSCLC: a consensus statement from the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021;16(10):1647-1662. 22. Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346. 23. Pennell NA, Mutebi A, Zhou ZY, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9. 24. Data on file. Genentech, Inc. 25. LUNGevity Foundation. Payer Coverage Policies of Tumor Biomarker Testing, September 2020. https://lungevity.org/sites/default/files/biomarker/ACS-CAN-LUNGevity_PayerCoveragePoliciesofTumorBiomarkerTesting_092020.pdf. Accessed April 20, 2022. 26. Centers for Medicare & Medicaid Services. Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450I). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=296. Accessed April 20, 2022.
Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: current therapies and new targeted treatments. Lancet. 2017;389(10066):299-311.
Hirsch FR, Scagliotti GV, Mulshine JL, et al. Lung cancer: current therapies and new targeted treatments. Lancet. 2017;389(10066):299-311.
VanderLaan PA, Rangachari D, Costa DB. The rapidly evolving landscape of biomarker testing in non-small cell lung cancer. Cancer Cytopathol. 2021;129(3):179-181.
VanderLaan PA, Rangachari D, Costa DB. The rapidly evolving landscape of biomarker testing in non-small cell lung cancer. Cancer Cytopathol. 2021;129(3):179-181.
US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc. Accessed July 7, 2022.
US Food and Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sotorasib-kras-g12c-mutated-nsclc. Accessed July 7, 2022.
König D, Prince SS, Rothschild SI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers (Basel). 2021;13(4):804.
König D, Prince SS, Rothschild SI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers (Basel). 2021;13(4):804.
Peters S, Reck M, Smit EF, Mok T, Hellmann MD. How to make the best use of immunotherapy as first-line treatment of advanced/metastatic non-small-cell lung cancer. Ann Oncol. 2019;30:884-896.
Peters S, Reck M, Smit EF, Mok T, Hellmann MD. How to make the best use of immunotherapy as first-line treatment of advanced/metastatic non-small-cell lung cancer. Ann Oncol. 2019;30:884-896.
Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.
Zhang YL, Yuan JQ, Wang KF, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.
Skov B, Rørvig SB, Lindkær TH, et al. The prevalence of programmed death-ligand-1 (PD-L1) expression in non-small cell lung cancer in an unselected, consecutive population. Mod Pathol. 2020;33(1):109-117.
Skov B, Rørvig SB, Lindkær TH, et al. The prevalence of programmed death-ligand-1 (PD-L1) expression in non-small cell lung cancer in an unselected, consecutive population. Mod Pathol. 2020;33(1):109-117.
Russo A, Lopes AR, McCusker MG, et al. New targets in lung cancer (excluding EGFR, ALK, ROS1). Curr Oncol Rep. 2020;22(5):48.
Russo A, Lopes AR, McCusker MG, et al. New targets in lung cancer (excluding EGFR, ALK, ROS1). Curr Oncol Rep. 2020;22(5):48.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 23, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 23, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.
Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017;6(2):196-211.
Malhotra J, Jabbour SK, Aisner J. Current state of immunotherapy for non-small cell lung cancer. Transl Lung Cancer Res. 2017;6(2):196-211.
Sandler JE, D’Aiello A, Halmos B. Changes in store for early-stage non-small cell lung cancer. J Thorac Dis. 2019;11(5):2117-2125.
Sandler JE, D’Aiello A, Halmos B. Changes in store for early-stage non-small cell lung cancer. J Thorac Dis. 2019;11(5):2117-2125.
Yi C, He Y, Xia H, Zhang P. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC. Onco Targets Ther. 2019;12:7329-7336.
Yi C, He Y, Xia H, Zhang P. Review and perspective on adjuvant and neoadjuvant immunotherapies in NSCLC. Onco Targets Ther. 2019;12:7329-7336.
Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006.
Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311(19):1998-2006.
Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016;387(10026):1415-1426.
Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016;387(10026):1415-1426.
Solomon BJ, Kim DW, Wu YL, et al. J Clin Oncol. 2018;36(22):2251-2258.
Solomon BJ, Kim DW, Wu YL, et al. J Clin Oncol. 2018;36(22):2251-2258.
Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities. Clin Lung Cancer. 2017;18(6):651-659.
Gutierrez ME, Choi K, Lanman RB, et al. Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities. Clin Lung Cancer. 2017;18(6):651-659.
Offin M, Guo R, Wu SL, et al. lmmunophenotype and response to immunotherapy of RET-rearranged lung cancers. JCO Precis Oncol. 2019;3:PO.18.00386.
Offin M, Guo R, Wu SL, et al. lmmunophenotype and response to immunotherapy of RET-rearranged lung cancers. JCO Precis Oncol. 2019;3:PO.18.00386.
Lisberg A, Cummings A, Goldman JW, et al. J Thorac Oncol. 2018;13(8):1138-1145.
Lisberg A, Cummings A, Goldman JW, et al. J Thorac Oncol. 2018;13(8):1138-1145.
Lin JJ, Chin E, Yeap BY, et al. J Thorac Oncol. 2018;14(1):135-140.
Lin JJ, Chin E, Yeap BY, et al. J Thorac Oncol. 2018;14(1):135-140.
Schoenfeld AJ, Arbour KC, Rizvi H, et al. Ann Oncol. 2019;30(5):839-844.
Schoenfeld AJ, Arbour KC, Rizvi H, et al. Ann Oncol. 2019;30(5):839-844.
Rolfo C, Mack P, Scagliotti GV, et al. Liquid biopsy for advanced NSCLC: a consensus statement from the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021;16(10):1647-1662.
Rolfo C, Mack P, Scagliotti GV, et al. Liquid biopsy for advanced NSCLC: a consensus statement from the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021;16(10):1647-1662.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346.
Lindeman NI, Cagle PT, Aisner DL, et al. Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. Arch Pathol Lab Med. 2018;142(3):321-346.
Pennell NA, Mutebi A, Zhou ZY, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.
Pennell NA, Mutebi A, Zhou ZY, et al. Economic impact of next-generation sequencing versus single-gene testing to detect genomic alterations in metastatic non–small-cell lung cancer using a decision analytic model. JCO Precis Oncol. 2019;3:1-9.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
LUNGevity Foundation. Payer Coverage Policies of Tumor Biomarker Testing, September 2020. https://lungevity.org/sites/default/files/biomarker/ACS-CAN-LUNGevity_PayerCoveragePoliciesofTumorBiomarkerTesting_092020.pdf. Accessed April 20, 2022.
LUNGevity Foundation. Payer Coverage Policies of Tumor Biomarker Testing, September 2020. https://lungevity.org/sites/default/files/biomarker/ACS-CAN-LUNGevity_PayerCoveragePoliciesofTumorBiomarkerTesting_092020.pdf. Accessed April 20, 2022.
Centers for Medicare & Medicaid Services. Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450I). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=296. Accessed April 20, 2022.
Centers for Medicare & Medicaid Services. Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450I). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=296. Accessed April 20, 2022.
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