AstraZeneca releases positive overall survival results for 'Tagrisso'

AstraZeneca announced positive overall survival results from the phase 3 FLAURA trial on Friday - a randomised, double-blinded, multi-centre trial of 'Tagrisso' (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC), whose tumours had epidermal growth factor receptor (EGFR) mutations.

The FTSE 100 pharmaceuticals behemoth said Tagrisso showed a “statistically-significant” and “clinically-meaningful” improvement in overall survival, which was a secondary endpoint in the FLAURA phase 3 trial, compared with erlotinib or gefitinib, which were previous standard-of-care treatments in such a setting.

It said the FLAURA trial met its primary endpoint in July 2017, showing a “statistically-significant” and “clinically-meaningful” improvement in progression-free survival, 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, the company 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 first-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer,” said AstraZeneca’s executive vice-president of oncology research and development José Baselga.

AstraZeneca said it planned to present the overall survival results from the FLAURA trial at a forthcoming medical meeting.

Tagrisso was currently approved in 74 countries, including the United States, Japan and the European Union, for first-line EGFRm metastatic NSCLC.