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

  • *

  • Blinded Independent Central Review assessment of CNS efficacy in the subgroup of 116/419 (28%) patients identified to have CNS metastases on a baseline brain scan.

  • †

  • CNS ORR and CNS DoR evaluated in population with CNS measurable lesions at baseline.

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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

  • *

  • cobas® EGFR Mutation Test v2 (Roche Molecular Systems).

  • †

  • Platinum-pemetrexed (every 3 weeks for up to 6 cycles of pemetrexed 500 mg/m2 plus either carboplatin AUC5 or cisplatin 75 mg/m2). Patients whose disease had not progressed after 4 cycles of platinum-pemetrexed could continue maintenance pemetrexed according to the approved label.

  • ‡

  • Patients could receive study treatment beyond RECIST-defined progression as long as they experienced clinical benefit, as judged by the investigator.

  • §

  • In the platinum-pemetrexed group, 67% (n=94) of patients crossed over to receive TAGRISSO. Patients on platinum-pemetrexed could cross over to TAGRISSO after BICR-confirmed progression.

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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

  • *

  • Using cobas® EGFR Mutation Test v2.

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.