AstraZeneca announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multicenter trial of TAGRISSO in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations.
TAGRISSO showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of TAGRISSO was consistent with its established profile.
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“Today’s positive results show that TAGRISSO provides an unprecedented survival outcome versus previous standard-of-care epidermal growth factor receptor tyrosine kinase inhibitors, reaffirming TAGRISSO as the 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer,” José Baselga, Executive Vice President, Oncology R&D said.
TAGRISSO is currently approved in more than 74 countries, including the US, Japan and the EU, for 1st-line EGFR-mutated metastatic NSCLC.