AstraZeneca has published results from its Phase III FLAURA trial showing that in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) its drug Tagrisso (osimertinib) performed better than erlotinib or gefitinib, the standard of care for this indication.
Erlotinib, gefitinib and Tagrisso are all epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), which target EGFR-sensitising and EGFR T790m-resistance mutations. All three are approved for locally-advanced or metastatic EGFR-mutated NSCLC.
In April 2018, the US Food and Drug Administration approved Tagrisso as a first-line therapy for NSCLC was based on prior data from the FLAURA trial, which showed that the drug caused a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the primary endpoint, compared to the two other EGFR-TKIs.
AstraZeneca executive vice-president and oncology business unit head Dave Fredrickson said: “Tagrisso delivered unprecedented median PFS data across all pre-specified patient subgroups, including patients with or without central nervous system metastases, and could prolong the lives of more patients without their tumours growing or spreading.”
The company’s latest update is based upon long-term overall survival (OS) data from the FLAURA study; where Tagrisso demonstrated a statistically significant and clinically meaningful improvement compared to the two other drugs. The full OS results from the FLAURA trial will be presented at an upcoming medical meeting.
The safety and tolerability of Tagrisso in FLAURA was consistent with its existing profile.
AstraZeneca Oncology research and development 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 1st-line standard-of-care for EGFR-mutated metastatic non-small cell lung cancer.”
Tagrisso is also being investigated for other clinical settings, such as the adjuvant setting and the locally-advanced unresectable setting, both alone and in combination with existing and potential new medicines.