AstraZeneca has announced positive overall survival (OS) 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 trial tested the drug in patients whose tumours have epidermal growth factor receptor (EGFR) mutations, and found that it showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial.
The trial previously 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 drug, a third-generation, irreversible EGFR-TKI, is designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases.
It has now received approval in more than 70 countries, including the US, Japan and the EU, for 1st-line EGFRm advanced NSCLC, and in more than 80 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC.
José Baselga, executive vice president, Oncology R&D said the 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.”
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined. It is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% classified as NSCLC.