AstraZeneca has reported positive results from the Phase III Flaura trial evaluating Tagrisso (osimertinib) in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC).
The randomised, double-blinded, multi-centre trial of the drug showed a statistically-significant and clinically-meaningful improvement in the secondary endpoint of overall survival (OS) compared to erlotinib or gefitinib.
The primary endpoint of the Flaura trial was met in July 2017, with the drug showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) in previously untreated patients who were epidermal growth factor receptor mutation (EGFRm) positive.
AstraZeneca noted that the safety and tolerability of Tagrisso was consistent with its established profile.
The Flaura trial evaluated the efficacy and safety of a once-daily 80mg oral dose of Tagrisso versus comparator EGFR-TKIs in previously untreated patients with locally-advanced or EGFRm NSCLC.
A total of 556 patients in 29 countries were selected for the trial.
AstraZeneca Oncology R&D executive vice-president José Baselga 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.”
The drug is currently approved in 74 countries, including the US and Japan, for first-line EGFRm metastatic NSCLC.
Tagrisso is a third-generation, irreversible EGFR-TKI that has been designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.
The drug is being developed in the adjuvant setting, in the locally-advanced unresectable setting, in combination with chemotherapy, and with potential new medicines.