COMPREHENSIVE BIOMARKER TESTING
TAKE A DEEPER LOOK.

Finding actionable biomarkers may be what's missing from an optimized treatment plan for mNSCLC.

Contact your local biomarker testing specialist

BIOMARKER TESTING IS AN IMPORTANT FIRST STEP IN DIAGNOSIS OF mNSCLC

Before selecting a first-line therapy for a patient with mNSCLC, 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.

60% oncogenic drivers and about 2 in 3 are actionable

MORE THAN 60%

of all non-squamous mNSCLC patients have oncogenic drivers—and of these patients, about 2 in 3 have an actionable biomarker1-5*

*Regardless of PD-L1 expression.

Targeted Therapy

TARGETED THERAPIES

may lead to better outcomes in patients with actionable biomarkers6-9

  • Some biomarker-driven cancers may respond poorly to less-targeted options like immunotherapy (IO) — these patients are often excluded from IO clinical trials10,11
  • Starting patients on IO and switching to a targeted therapy may lead to increased risk for immune-related adverse events12,13

NCCN GUIDELINES® RECOMMENDATIONS FOR BIOMARKER TESTING IN NSCLC

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend14:

Molecular testing be performed (when feasible) via a broad panel-based approach, typically by next-generation sequencing (NGS), for patients with mNSCLC

Upfront PD-L1 expression testing before first-line therapy in patients with mNSCLC

Patients, across all PD-L1 expression levels, are negative for actionable molecular markers before utilizing IO as a first-line treatment option for mNSCLC

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.

UNDERSTANDING THE BENEFIT OF COMPREHENSIVE BIOMARKER TESTING

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.14 NGS can assess most actionable biomarkers with one test—so you can identify if a biomarker is responsible for driving disease.15

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 testing16

Biomarker Test

Account for multiple
biomarkers with one test

Biopsy Microscope

Fewer rebiopsies and
complications

Calendar

Shorter time-to-test
results

Cost Savings

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.16

 Single-Gene Testing vs NGS

For Medicare-insured or commercially insured patients.

HEALTHCARE SYSTEM COST SAVINGS AND COVERAGE OF NGS

Healthcare system cost savings per patient by ordering NGS instead of single-gene sequential 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.16

~$700

cost savings per
Medicare-insured patients

~$800

cost savings per
commercially insured patients

§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.

NGS IS GENERALLY COVERED FOR PATIENTS WITH mNSCLC ACROSS LARGE PAYER NETWORKS17,18‡‡

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.19

When all of the following requirements are met:

  • Ordered by a treating physician
  • Patient has:
    • either recurrent, relapsed, refractory, metastatic, or advanced stage III or IV cancer; and,
    • either not been previously tested using the same NGS test for the same primary diagnosis of cancer, or repeat testing using the same NGS test only when a new primary cancer diagnosis is made by the treating physician; and,
    • decided to seek further cancer treatment (eg, therapeutic chemotherapy)
  • The diagnostic laboratory test using NGS must have FDA approval or clearance as a companion in vitro diagnostic; and, an FDA-approved or FDA-cleared indication for use in that patient’s cancer; and, results provided to the treating physician for management of the patient using a report template to specify treatment options

‡‡ Diagnostic coverage may vary across payers.

GENENTECH IS COMMITTED TO FIGHTING LUNG CANCER

ALK=anaplastic lymphoma kinase; BRAF=B-Raf proto-oncogene; CLIA=clinical laboratory improvement amendments; CMS=Centers for Medicare & Medicaid Services; EGFR=epidermal growth factor receptor; FISH=fluorescence in situ hybridization; HER2=human epidermal growth factor receptor 2; IHC=immunohistochemistry; KRAS=Kirsten rat sarcoma viral oncogene homolog; MET=MET proto-oncogene; mNSCLC=metastatic non–small cell lung cancer; NCCN®=National Comprehensive Cancer Network®; NTRK1=neurotrophic tyrosine kinase receptor type 1; PCR=polymerase chain reaction; PD-L1=programmed death ligand 1; 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 June 10, 2021. 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. 2021;13(4):1-52. 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. 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. 7. Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of cancer: results of a one-year nationwide program of the French Cooperative Thoracic Intergroup (IFCT) for advanced non-small cell lung cancer (NSCLC) patients. Lancet. 2016;387(10026):1415-1426. 8. Solomon BJ, Kim D-W, Wu Y-L, et al. J Clin Oncol. 2018;36(22):2251-2258. 9. 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. 10. 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. doi:10.1200/PO.18.00386. 11. Lisberg A, Cummings A, Goldman JW, et al. J Thorac Oncol. 2018;13(8):1138-1145. 12. Lin JJ, Chin E, Yeap BY, et al. J Thorac Oncol. 2018;14(1):135-140. 13. Schoenfeld AJ, Arbour KC, Rizvi H, et al. Ann Oncol. 2019;30(5):839-844. 14. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer V.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 17, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. 15. Lindeman NJ, 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. 16. Pennell NA, Mutebi A, Zhou Z-Y, 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. 17. Data on file. Genentech Oncology, CA 2021. 18. 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 June 17, 2021. 19. Center for Medicare & Medicaid Services: Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290. Accessed May 20, 2021.

    • 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.

    • König D, Prince SS, RothschildSI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers. 2021;13(4):1-52.

      König D, Prince SS, RothschildSI. Targeted therapy in advanced and metastatic non-small cell lung cancer. An update on treatment of the most important actionable oncogenic driver alterations. Cancers. 2021;13(4):1-52.

    • 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.

    • 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 cancer: results of a one-year nationwide program of the French Cooperative Thoracic Intergroup (IFCT) for advanced non-small cell lung cancer (NSCLC) patients. Lancet. 2016;387(10026):1415-1426.

      Barlesi F, Mazières J, Merlio JP, et al. Routine molecular profiling of cancer: results of a one-year nationwide program of the French Cooperative Thoracic Intergroup (IFCT) for advanced non-small cell lung cancer (NSCLC) patients. Lancet. 2016;387(10026):1415-1426.

    • Solomon BJ, Kim D-W, Wu Y-L, et al. J Clin Oncol. 2018;36(22):2251-2258.

      Solomon BJ, Kim D-W, Wu Y-L, 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. doi:10.1200/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. doi:10.1200/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.

    • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Non-Small Cell Lung Cancer V.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 17, 2021. 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.5.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 17, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org.

    • Lindeman NJ, 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 NJ, 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 Z-Y, 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 Z-Y, 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 Oncology, CA 2021.

      Data on file. Genentech Oncology, CA 2021.

    • 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 June 17, 2021.

      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 June 17, 2021.

    • Center for Medicare & Medicaid Services: Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290. Accessed May 20, 2021.

      Center for Medicare & Medicaid Services: Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450N). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=290. Accessed May 20, 2021.