EGFR, also known as epidermal growth factor receptor, is a genomic biomarker that identifies mNSCLC patients eligible for targeted therapy1
Metastatic NSCLC patients who express PD-L1 can also have an EGFR mutation3-7
No immunotherapy is approved by the FDA for first-line use in metastatic EGFRm NSCLC17-19
Plasma testing may help find mutations that tissue biopsy alone would miss20,21
Confirm that your patient has been tested for their full molecular profile
Check that all test results have been received before starting treatment
Discuss all molecular test results with the physician
AUC, area under the curve; AEs, adverse events; ECG, electrocardiogram; EGFRm, epidermal growth factor receptor mutant; FDA, US Food and Drug Administration; mNSCLC, metastatic non-small cell lung cancer; MRI, magnetic resonance imaging; PET, positron emission tomography; PK, pharmacokinetics; TKI, tyrosine kinase inhibitor.
References: 1. Shah RR, Shah DR. Safety and tolerability of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in oncology. Drug Saf. 2019;42:181-198. 2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.2.2020. ©National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed December 23, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. 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. 3. Akamine T, Takada K, Toyokawa G, et al. Association of preoperative serum CRP with PD-L1 expression in 508 patients with non-small cell lung cancer: a comprehensive analysis of systemic inflammatory markers. Surg Oncol. 2018;27(1):88-94. 4. D’Incecco A, Andreozzi M, Ludovini V, et al. PD-1 and PD-L1 expression in molecularly selected non-small-cell lung cancer patients. Br J Cancer. 2015;112(1):95-102. 5. Liu SY, Dong ZY, Wu SP, et al. Clinical relevance of PD-L1 expression and CD8+ T cells infiltration in patients with EGFR-mutated and ALK-rearranged lung cancer. Lung Cancer. 2018;125:86-92. 6. Yoneshima Y, Ijichi K, Anai S, et al. PD-L1 expression in lung adenocarcinoma harboring EGFR mutations or ALK rearrangements. Lung Cancer. 2018;118:36-40. 7. Brown H, Vansteenkiste JF, Nakagawa K, et al. PD-L1 expression in untreated EGFRm advanced NSCLC and response to osimertinib and SoC EGFR-TKIs in the FLAURA trial. Presented at: IASLC WCLC; September 23-26, 2018; Toronto, Canada. 8. Brahmer JR, Govindan R, Anders RA, et al. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC). J Immunother Cancer. 2018;6(1):75. 9. Reck M, Rodríguez-Abreu D, Robinson AG, et al; KEYNOTE-024 Investigators. Pembrolizumab versus chemotherapy for PD-L1–positive non-small-cell lung cancer. N Engl J Med. 2016;375(19):1823-1833. 10. Clinicaltrials.gov. Study of pembrolizumab (MK-3475) versus platinum-based chemotherapy for participants with programmed cell death-ligand (PD-L1)-positive advanced or metastatic non-small cell lung cancer (MK-3475-042/KEYNOTE-042). https://clinicaltrials.gov/ct2/show/NCT02220894. Accessed January 9, 2019. 11. Langer CJ, Gadgeel SM, Borghaei H, et al; KEYNOTE-021 Investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016;17(11):1497-1508. 12. Broderick JM. Frontline pembrolizumab combo improves survival in phase III NSCLC trial. https://www.onclive.com/web-exclusives/frontline-pembrolizumab-combo-improves-survival-in-phase-iii-nsclc-trial. Published January 16, 2018. Accessed August 15, 2019. 13. Carbone DP, Reck M, Paz-Ares L, et al; CheckMate 026 Investigators. First-line nivolumab in stage IV or recurrent non–small-cell lung cancer. N Engl J Med. 2017;376(25): -2426. 14. Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med. 2018;378(22):2093-2104. 15. EU Clinical Trials Register. A phase III clinical study to evaluate the efficacy and safety of atezolizumab in combination with carboplatin + nab-paclitaxel compared with carboplatin + nab-paclitaxel in patients with stage IV non-squamous non-small cell lung cancer. EudraCT number 2014-003206-32. https://www.clinicaltrialsregister.eu/. Accessed August 15, 2019. 16. Kowanetz M, Socinski MA, Zou W, et al. Impower150: efficacy of atezolizumab plus bevacizumab and chemotherapy across PD-L1 expression subgroups defined by the SP142 and SP263 IHC assays confirm all-comer benefit in 1L metastatic NSCLC. Presented at: AACR; April 14-18, 2018; Chicago, IL. 17. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2019. 18. Tecentriq [package insert]. South San Francisco, CA: Genentech Inc; 2019. 19. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2019. 20. Aggarwal C, Thompson JC, Black TA, et al. Clinical implications of plasma-based genotyping with the delivery of personalized therapy in metastatic non-small cell lung cancer. JAMA Oncol. 2019;5(2):173-180. 21. Leighl N, Page R, Raymond V, et al. Clinical utility of comprehensive cell-free DNA analysis to identify genomic biomarkers in patients with newly diagnosed metastatic non-small cell lung cancer. Clin Cancer Res. 2019;25(15):4691-4700. 22. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 23. Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR-TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4(9):1046-1061. 24. Finlay MR, Anderton M, Ashton S, et al. Discovery of a potent and selective EGFR inhibitor (AZD9291) of both sensitizing and T790M resistance mutations that spares the wild type form of the receptor. J Med Chem. 2014;57(20):8249-8267. 25. TAGRISSO [package insert]. Wilmington DE: AstraZeneca Pharmaceuticals LP; 2019. 26. Ballard P, Yates JW, Yang Z, et al. Preclinical comparison of osimertinib with other EGFR-TKIs in EGFR-mutant NSCLC brain metastases models, and early evidence of clinical brain metastases activity. Clin Cancer Res. 2016;22(20):5130-5140. 27. Colclough N, Ballard P, Barton P, et al. Preclinical comparison of the blood brain barrier (BBB) permeability of osimertinib (AZD9291) with other irreversible next generation EGFR-TKIs. Eur J Cancer. 2016;69:S28. 28. Varrone A, Varnäs K, Jucaite A, et al. A PET study in healthy subjects of brain exposure of 11C-labeled osimertinib: A drug intended for treatment of brain metastases in non-small cell lung cancer. J Cereb Blood Flow Metab. 2019. doi:10.1177/0271678X19843776.
TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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