EGFR, also known as epidermal growth factor receptor, is a genomic biomarker that identifies mNSCLC patients eligible for targeted therapy1
For your patients with resectable or metastatic NSCLC
Confirming your patient’s EGFR mutation status is a critical first step in resectable or metastatic NSCLC
Molecular testing for EGFR mutations in patients with resectable stage IB to IIIA NSCLC is now included in NCCN Guidelines® to inform adjuvant treatment decisions.1*†
EGFR MUTATIONS ARE PREVALENT ACROSS STAGES IN ADENOCARCINOMA2-5‡
EGFR mutations lead to unregulated proliferation and survival of tumor cells, making EGFR a key driver of disease regardless of stage2-4,6
TAGRISSO is a targeted therapy precisely designed to inhibit EGFR sensitizing mutations7
*The NCCN Guidelines® for NSCLC provide recommendations for individual biomarkers that should be tested and recommend testing techniques, but do not endorse any specific commercially available biomarker assays.1
†Consider osimertinib for patients with completely resected stage IIB-IIIA and high-risk stage IB-IIA EGFRm NSCLC who received previous adjuvant chemotherapy or are ineligible to receive platinum-based chemotherapy.1
For your patients with resectable NSCLC
An EGFR mutation can be the hidden driver of disease. How can you help identify eligible EGFRm patients?9
Help support testing to confirm EGFRm status early on and ensure resectable NSCLC patients can have a chance to benefit from adjuvant TAGRISSO
EGFR (epidermal growth factor receptor) is a biomarker that, when mutated, can cause NSCLC to grow and spread. Knowing which of your patients have EGFR mutations can help you identify patients who are eligible for therapy that targets the mutation.10
adjuvant treatment and testing with patients
your patients to a medical oncologist as early as possible
every surgical specimen is tested for EGFR mutations
Give your eligible patients the chance to benefit fromADJUVANT TAGRISSO
Help your resectable NSCLC patients understand how important it is to get tested for EGFR mutations as early as possible, because testing can help determine what’s driving their disease and options may be available for adjuvant treatment
*KEYNOTE-024, KEYNOTE-042, KEYNOTE-021 Cohort G, KEYNOTE-189, CHECKMATE 026, CHECKMATE 227, CHECKMATE 9LA, IMpower110, IMpower130, IMpower132, and IMpower150. In the IMpower130 and IMpower150 trials, EGFRm patients were allowed only after progression on EGFR-TKI therapy or intolerance to EGFR-TKI treatment.
No immunotherapy is approved by the FDA for first-line use in metastatic EGFRm NSCLC29-31
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
TAGRISSO selectively targets EGFR sensitizing and resistance mutations7,32-34
AEs, adverse events; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation positive; FDA, US Food and Drug Administration; L858R, exon 21 leucine 858 arginine substitution; MRI, magnetic resonance imaging; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; PET, positron emission tomography; PK, pharmacokinetics; T790M, exon 20 threonine 790 methionine substitution; TKI, tyrosine kinase inhibitor.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.4.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 3, 2021. 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. 2. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. J Thorac Oncol. 2015;10(5):768-777 [supplementary appendix]. 3. Jones DR. Introducing tumor genomics to predict recurrence following complete resection of lung adenocarcinoma. Presented at: 2019 Annual Meeting of the American Association for Thoracic Surgery; May 4-7, 2019; Toronto, Canada. 4. D'Angelo SP, Janjigian YY, Ahye N, et al. Distinct clinical course of EGFR-mutant resected lung cancers: results of testing of 1118 surgical specimens and effects of adjuvant gefitinib and erlotinib. J Thorac Oncol. 2012;7(12):1815-1822. 5. Jordan EJ, Kim HR, Arcila ME, et al. Prospective comprehensive molecular characterization of lung adenocarcinomas for efficient patient matching to approved and emerging therapies [published online ahead of print March 23, 2017]. Cancer Discov. doi:10.1158/2159-8290.CD-16-1337. 6. Black RC, Khurshid H. NSCLC: an update of driver mutations, their role in pathogenesis and clinical significance. R I Med J. 2015;98(10):25-28. 7. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 8. Sholl LM, Aisner DL, Varella-Garcia M, et al; LCMC Investigators. Multi-institutional oncogenic driver mutation analysis in lung adenocarcinoma: The Lung Cancer Mutation Consortium experience. J Thorac Oncol. 2015;10(5):768-777. 9. Chae YK, Oh MS. Detection of minimal residual disease using ctDNA in lung cancer: current evidence and future directions. J Thorac Oncol. 2019;14(1):16-24. 10. Shah RR, Shah DR. Safety and tolerability of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in oncology. Drug Saf. 2019;42(2):181-198. 11. 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. 12. 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. 13. 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. 14. 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. 15. Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. J Thorac Oncol. 2020;15(1):138-143. 16. 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. 17. 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. 18. Clinicaltrials.gov. Study of MK-3475 (pembrolizumab) versus platinum-based chemotherapy for participants with PD-L1-positive advanced or metastatic non-small cell lung cancer (MK-3475-042/KEYNOTE-042). https://clinicaltrials.gov/ct2/show/NCT02220894. Accessed July 1, 2020. 19. 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. 20. 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 November 20, 2020. 21. Carbone DP, Reck M, Paz-Ares L, et al; CheckMate026 Investigators. First-line nivolumab in stage IV or recurrent non–small-cell lung cancer. N Engl J Med. 2017;376(25):2415-2426. 22. 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. 23. EU Clinical Trials Register. A phase III multicenter, randomized, open-label study evaluating the efficacy and safety of atezolizumab (MPDL3280A, anti-PD-L1 antibody) in combination with carboplatin+nab-paclitaxel for chemotherapy-naive patients with stage IV non-squamous non-small cell lung cancer. EudraCT number 2014-003206-32. 24. 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. 25. Papadimitrakopoulou VA, Cobo M, Bordoni R, et al. IMpower132: PFS and safety results with 1L atezolizumab + carboplatin/cisplatin + pemetrexed in stage IV non-squamous NSCLC [oral presentation]. Presented at: IASLC WCLC; September 23-26, 2018; Toronto, Canada. 26. Clinicaltrials.gov. A study of nivolumab and ipilimumab combined with chemotherapy compared to chemotherapy alone in first line NSCLC (CheckMate 9LA). https://clinicaltrials.gov/ct2/show/NCT03215706. Accessed July 1, 2020. 27. Spigel D, de Marinis F, Giaccone G, et al. IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Presented at: European Society for Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA78. 28. Clinicaltrials.gov. A study of atezolizumab (MPDL3280A) compared with a platinum agent (cisplatin or carboplatin) + (pemetrexed or gemcitabine) in participants with stage IV non-squamous or squamous non-small cell lung cancer (NSCLC) [IMpower110]. https://clinicaltrials.gov/ct2/show/NCT02409342. Accessed July 1, 2020. 29. Keytruda [package insert]. Whitehouse Station, NJ: Merck & Co., Inc; 2020. 30. Tecentriq [package insert]. South San Francisco, CA: Genentech Inc.; 2020. 31. Opdivo [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2020. 32. 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. 33. 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. 34. Finlay MR, Anderton M, Ashton S, et al. Discovery of 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. 35. 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. 36. Colclough N, Ballard PG, 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. 37. 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. 2020;40(4):799-807.
TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with 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
TAGRISSO is indicated for the first-line treatment of adult 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
TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
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