Tagrisso demonstrated superior progression-free survival (PFS) of 18.9 months compared with 10.2 months for the current standard of care and an encouraging preliminary overall survival benefit CAMBRIDGE, England--(BUSINESS WIRE)--AstraZeneca today announced that the New England Journal of Medicine has published the positive results from the Phase III FLAURA trial which provide data for Tagrisso’s (osimertinib) use in the 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).1 The trial showed a statistically significant, clinically meaningful progression-free survival (PFS) advantage for osimertinib, a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI), compared with current 1st-line EGFR-TKIs, erlotinib or gefitinib.1 Dr. Suresh S. Ramalingam, Principal Investigator of the FLAURA trial, from the Winship Cancer Institute of Emory University, Atlanta, USA, said: “The results of the FLAURA trial may herald a shift in how we treat patients with EGFR-mutated NSCLC. The data demonstrate superiority of osimertinib compared to current standard EGFR-TKIs in the 1st-line setting.” Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “EGFR-mutated NSCLC patients need new therapies that improve outcomes. The data published in NEJM today further emphasise the potential of osimertinib as a new treatment standardin this patient population.” In the Phase III FLAURA trial, osimertinib significantly improved PFS compared to erlotinib or gefitinib in previously untreated patients with locally advanced or metastatic EGFR-mutated (EGFRm) NSCLC. Median PFS was nearly doubled at 18.9 months for osimertinib compared with 10.2 months for the EGFR-TKI comparator arm (PFS, hazard ratio [HR] 0.46; 95% confidence interval [CI] 0.37-0.57; p<0.001). Preliminary overall survival (OS) data favoured osimertinib with a 37% reduction in the risk of death (HR 0.63, 95% CI 0.45-0.88; p=0.007 [not significant]) at the interim OS analysis (25% maturity).1 The FLAURA safety data for osimertinib were in line with those observed in prior clinical trials. Osimertinib was well tolerated, with less frequent grade 3 or higher adverse events (AEs) than with standard EGFR-TKIs (34% vs. 45%). In all patients, the most common AEs were rash or acne (58% [1% Grade ≥3] for osimertinib vs. 78% [7% Grade ≥3] for the comparator arm), diarrhoea (58% [2% Grade ≥3] for osimertinib vs. 57% [2% Grade ≥3] for the comparator arm), and dry skin (36% [<1% Grade ≥3] for osimertinib vs. 36% [1% Grade ≥3] for the comparator arm).1 AstraZeneca presented the full FLAURA data at the Presidential Symposium of the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, in September. NOTES TO EDITORS
About NSCLC
About Tagrisso
About FLAURA
About AstraZeneca in Lung Cancer
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Intended audiences References 1 Soria, JC, et al. Osimertinib in EGFR Mutation-Positive Advanced Non-Small Cell Lung Cancer. NEJM. To be published 18 Nov 2017. 2 American Cancer Society. Key Statistics for Lung Cancer. Available at https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics.html. Accessed November 2017. 3 Szumera-Ciekiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. 4 Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 5 Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89. 6 Langer CJ, et al. Epidermal Growth Factor Receptor Inhibition in Mutation-Positive Non-Small-Cell Lung Cancer: Is Afatinib Better or Simply Newer? J Clin Oncol. 2013:31(27);3303-05. 7 Yu HA, et al. Analysis of Tumour Specimens at the Time of Acquired Resistance to EGFR-TKI Therapy in 155 Patients with EGFR-Mutant Lung Cancer. Clin Cancer Research. 2013:19(8);2240-46. 8 Wu SG, et al. The Mechanism of Acquired Resistance to Irreversible EGFR Tyrosine Kinase Inhibitor Afatinib in Lung Adenocarcinoma Patients. Oncotarget. 2016:7(11);12404-13. 9 Rangachari, et al. Brain Metastases in Patients with EGFR-Mutated or ALK-Rearranged NonSmall-Cell Lung Cancers. Lung Cancer. 2015;88,108–111 10 Cross DAE, et al. AZD9291, an Irreversible EGFR TKI, Overcomes T790M-Mediated Resistance to EGFR Inhibitors in Lung Cancer. Cancer Discov. 2014:4;1046-61. 11 National Institutes of Health. AZD9291 Versus Placebo in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy (ADAURA). Available at: https://www.clinicaltrials.gov/ct2/show/NCT02511106. Accessed November 2017. 12 National Institutes of Health. AZD9291 in Combination With Ascending Doses of Novel Therapeutics. Available at: https://clinicaltrials.gov/ct2/show/NCT02143466. Accessed November 2017. 13 Ramalingam S, et al. Osimertinib vs SoC EGFR-TKI as First-Line Treatment in Patients with EGFRm Advanced NSCLC (FLAURA). Presented at the European Society for Medical Oncology (ESMO) 2017 Congress, 8-12 September 2017, Madrid, Spain.
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