“AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC).
“Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: ‘The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive non-small cell lung cancer, providing physicians with a potential new first-line treatment option to improve outcomes in this disease. We will now initiate discussions with global health authorities on the data and regulatory submissions.’ ”
“AstraZeneca today announced preliminary efficacy and safety data for AZD9291 in the first-line treatment of epidermal growth factor receptor mutation positive (EGFRm) advanced non-small cell lung cancer (NSCLC). Data showed that 81% (95% confidence interval (CI) 68% to 89%) of patients on a once daily dose of AZD9291 were progression free at 9 months; overall response rate was 73% (95% CI 60% to 84%). The longest duration of response was ongoing at 13.8 months at the time of data cutoff.1
“The data from the first-line expansion cohorts of the AURA Phase I study were presented at the annual meeting of the American Society of Clinical Oncology in Chicago. The first-line cohorts included 60 patients with EGFRm advanced NSCLC who received AZD9291 80mg or 160mg once daily. The data are not fully mature with an approximate 11 month median follow up in the 80mg cohort, and an approximate 8.5 month median follow up in the 160mg cohort. The most common adverse events in both cohorts included rash (grade 3:0% at 80mg)(grade 3:3% at 160mg) and diarrhea (grade 3:0% at 80mg)(grade 3:7% at 160mg).1
“ ‘These preliminary data demonstrate the potential of AZD9291 in treatment-naive advanced NSCLC patients with EGFR mutation. These promising results with AZD9291 will be studied further by the ongoing Phase III FLAURA trial2 in the first-line setting,’ said Professor Suresh S. Ramalingam, Chief of Medical Oncology, Emory University School of Medicine, Atlanta, GA, USA, who presented the AURA first-line data and is lead principal investigator for the FLAURA study.”