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.

PFSPFS
  • 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

PFS by CNSPFS 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 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

STUDY DESIGNSTUDY 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, 71% (n=99) 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 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

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 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

  • *Using cobas® EGFR Mutation Test v2.

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.

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