PFS

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

PFS PFS
  • Overall survival (OS) data were not mature at the time of this initial analysis (25% mature for TAGRISSO; 29% for platinum-pemetrexed [HR=0.72; 95% CI: 0.48, 1.09; P=0.121])

PFS by CNS metastases status at study entry in AURA3 (investigator assessment)2,3

PFS by CNS PFS by CNS
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CNS

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

CNS CNS
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STUDY DESIGN

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 (investigator assessment)

Secondary endpoints: ORR (investigator assessment), DoR, OS, DCR, tumour shrinkage, HRQoL, safety and tolerability

STUDY DESIGN STUDY DESIGN
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TESTING

Test for EGFR T790M upon progression on a 1st- or 2nd-generation EGFR TKI

Incorporating both plasma (ctDNA) and tissue tests into your practice may identify more patients with the EGFR T790M mutation4,5

TESTING TESTING
  • A positive tissue or plasma EGFR T790M test indicates eligibility for TAGRISSO1
  • Response rates on TAGRISSO are similar for patients who test positive for T790M using plasma or tissue6*
  • If plasma (ctDNA) test results are negative, follow up with a tissue test wherever possible due to the potential for false-negatives1
  • Only validated tests with demonstrated utility for determining EGFR T790M status should be used1
Ensure that your lab is prepared to detect the EGFR T790M mutation with plasma and tissue

References:
1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2018. 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 M-J, Han Y-J, et al. CNS response to osimertinib in patients with T790M-positive advanced NSCLC: data from a randomized phase III trial (AURA3). Paper presented at: American Society of Clinical Oncology Meeting, 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.