18 July 2016
AstraZeneca has announced that the Phase III AURA3 trial met its primary endpoint that demonstrates superior progression-free survival (PFS) in comparison to standard platinum-based doublet chemotherapy. The AURA3 randomized trial assessed the safety and efficacy of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials. At an upcoming medical meeting, the results of a full evaluation of AURA3 data, including an analysis of overall survival (OS), will be presented.
“These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer. We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need,” said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.