AURA3 was a Phase III, randomised, international, open-label study comparing TAGRISSO with platinum-pemetrexed in 419 patients with EGFR T790M mutation-positive NSCLC who had progressed on first-line TKI therapy.
Primary endpoint: PFS (investigator assessment)
Secondary endpoints: ORR (investigator assessment), DoR, OS, DCR, tumour shrinkage, HRQoL, safety and tolerability
1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2019. 2. Mok TS, Wu YL, Ahn MJ, et al; AURA3 Investigators. Osimertinib or platinum-pemetrexed in EGFR T790M positive lung cancer. N Engl J Med. 2016;376:629-640. 3. Mok T, Ahn MJ, Han JY, et al. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: data from a randomized phase III trial (AURA3). Paper presented at 2017 ASCO Annual Meeting; June 2-6, 2017; Chicago, IL. 4. cobas® EGFR Mutation Test v2 [package insert]. Indianapolis, IN: Roche Molecular Systems, Inc. 2016. 5. Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014;32:579-586. 6. Jenkins S, Yang J, Ramalingam S, et al. Plasma ctDNA analysis for detection of the EGFR T790M mutation in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2017;12:1061-1070.