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AstraZeneca: Tagrisso Shows Positive OS Results In Phase III FLAURA Trial

AstraZeneca plc (AZN.L,AZN) announced Friday results of Phase III FLAURA trial showing that Tagrisso (osimertinib) significantly improves overall survival for 1st-line EGFR-mutated non-small cell lung cancer or NSCLC.

The randomised, double-blinded, multi-centre trial of Tagrisso was in previously-untreated patients with locally-advanced or metastatic NSCLC whose tumours have epidermal growth factor receptor or EGFR mutations.

Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the trial, compared with erlotinib or gefitinib both of which were previous standard-of-care treatments in this setting.

The company noted that Tagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. It also increased the time patients with central nervous system metastases lived without disease progression.

The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival.

José Baselga, Executive Vice President, Oncology R&D said, "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."

AstraZeneca plans to present the OS results from the FLAURA trial at a forthcoming medical meeting.

Tagrisso is currently approved in 74 countries, including the US, Japan and the EU, for 1st-line EGFRm metastatic NSCLC.

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