Tagrisso FLAURA trial results : Pharma giant AstraZeneca said that the phase 3 FLAURA trial evaluating Tagrisso (osimertinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) has yielded positive overall survival (OS) results.
The randomized, double-blinded, multicenter late-stage trial featured NSCLC patients whose tumors have epidermal growth factor receptor (EGFR) mutations.
According to AstraZeneca, Tagrisso demonstrated a statistically-significant and clinically-meaningful improvement in OS, which is a secondary endpoint in the FLAURA clinical trial, compared with standard-of-care (SoC) treatments erlotinib or gefitinib.
The FLAURA trial achieved its primary endpoint in July 2017, demonstrating a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the lifetime of patients without disease progression or death from any cause. The safety and tolerability of Tagrisso were on par with its established profile, as per the latest Tagrisso FLAURA trial results.
Commenting on Tagrisso FLAURA trial results, Jose Baselga – Executive Vice President of AstraZeneca 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 Tagrisso FLAURA trial results pertaining to overall survival at an upcoming medical meeting.
Tagrisso has approvals in 74 plus countries, including the US, the EU, and Japan, for first line EGFR-mutated metastatic NSCLC.
The third-generation, irreversible EGFR TKI is designed to block EGFR-sensitizing and also EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.