Powerful efficacy demonstrated in AURA31

TAGRISSO demonstrated significantly greater efficacy vs platinum-pemetrexed in AURA3, an open-label, randomised, Phase III study in 419 patients with EGFR T790M mutation-positive advanced NSCLC who had progressed on a first-line TKI.

Median PFS was more than twice as long as with platinum-pemetrexed.

  • Overall survival (OS) data were not mature at the time of this initial analysis (67% mature for TAGRISSO; 66% for platinum-pemetrexed [HR=0.87; 95% CI: 0.67, 1.13; P=0.277])1

PFS by CNS metastases status at study entry in AURA3 (investigator assessment)1,2

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CNS response in patients with measurable CNS metastases at baseline in AURA3 (BICR)1*

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TAGRISSO was studied in AURA3, a Phase III randomised trial1,2

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 using investigator assessment according to RECIST v1.11,2

Secondary endpoints: ORR (investigator assessment), DoR, OS, DCR, tumour shrinkage, OS, PROs, safety, and tolerability1,2

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Test for EGFR T790M at the first sign of progression

Incorporating both plasma (ctDNA) and tissue tests into your practice may identify more patients with the EGFR T790M mutation3

  • A positive tissue or plasma EGFR T790M test indicates eligibility for TAGRISSO1
  • Response rates on TAGRISSO are similar for patients who test positive for the EGFR T790M mutation using plasma or tissue4*
  • If plasma results are negative, follow up with a tissue test wherever possible due to the potential for false negative results using a plasma-based test1
  • Only validated tests with demonstrated utility for determining EGFR T790M mutation status should be used. In AURA3, all patients were required to have EGFR T790M mutation-positive NSCLC identified by cobas® EGFR mutation test performed in a central laboratory prior to randomisation1
Ensure that your lab is prepared to detect the EGFR T790M mutation with liquid biopsy and tissue testing

References: 1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2021. 2. Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or platinum–pemetrexed in EGFR T790M–positive lung cancer. N Engl J Med. 2017;376(7):629-640. 3. Diaz LA Jr, Bardelli A. Liquid biopsies: genotyping circulating tumor DNA. J Clin Oncol. 2014;32(6):579-586. 4. Jenkins S, Yang JCH, Ramalingam SS, 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(7):1061-1070.