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).
“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,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
The efficacy, safety and tolerability profiles for Tagrisso, erlotinib and gefitinib were consistent with current knowledge. A full evaluation of the FLAURA data is ongoing. Further results will be presented at a forthcoming medical meeting.