Therapy Areas: Central Nervous System
AstraZeneca's Tagrisso improves overall survival in phase III Flaura trial
13 August 2019 -

United Kingdom-based AstraZeneca's Tagrisso (osimertinib) has improved overall survival in the patients with epidermal growth factor receptor mutated non-small cell lung cancer (NSCLC) in the phase III Flaura trial, it was reported yesterday.

The firm revealed positive overall survival results from the phase III randomised, double-blinded and multi-centre trial of Tagrisso in earlier-untreated patients with locally-advanced or metastatic NSCLC whose tumours have EGFR mutations.

The product showcased a statistically-significant and clinically-meaningful improvement in overall survival, a secondary endpoint in the phase III trial, compared against erlotinib or gefitinib, both of which were previous standard-of-care (SoC) treatments in this setting. With 556 patients across 29 countries, the Flaura study assessed the efficacy and safety of Tagrisso 80mg orally once daily against comparator EGFR-TKIs (either erlotinib [150mg orally, once daily] or gefitinib [250mg orally, once daily]) in earlier untreated patients with locally-advanced or metastatic EGFRm NSCLC. The product is a third-generation and irreversible EGFR-TKI designed to restrict inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.

The drug has presently secured approval in 74 countries, including the US, Japan and the EU, for first-line EGFRm metastatic NSCLC.

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