OS

First-line TAGRISSO:
The only treatment with median overall survival beyond 3 years1,2

In a global Phase III study of advanced EGFRm NSCLC1,3

OS OS

3-year survival was 54% on first-line TAGRISSO vs 44% on gefitinib/erlotinib2†

3-year survival was 54% on first-line TAGRISSO vs 44% on gefitinib/erlotinib2†

Nearly 30% of patients were still being treated with first-line TAGRISSO at 3 years2

OS OS

At the time of DCO, 22% of patients remained on first-line TAGRISSO vs 5% for gefitinib/erlotinib.2†‡

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PFS

First-line TAGRISSO delivered an unprecedented 18.9 months median PFS1,3

In a global Phase III study of advanced EGFRm NSCLC

PFS PFS
TAGRISSO demonstrated an early and sustained efficacy advantage with separation of the PFS KM curves starting at 6 weeks (time of first assessment)1,3
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PFS SUBGROUPS

First-line TAGRISSO demonstrated a consistent PFS benefit (HR <0.6) across all prespecified subgroups1,3

  • Including in patients with or without CNS metastases*
  • And in patients with exon 19 deletion or L858R
PFS SUBGROUPS PFS SUBGROUPS
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CNS

First-line TAGRISSO significantly reduced the risk of CNS progression by 52%1,2,4*

CNSCNS

Fewer patients on TAGRISSO progressed due to new CNS lesions vs gefitinib/erlotinib6*

CNSCNS
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STUDY DESIGN

First-line TAGRISSO was studied in FLAURA, a global, Phase III, double-blind, randomised study vs gefitinib/erlotinib1,3,4*

STUDY DESIGNSTUDY DESIGN
Crossover to second-line TAGRISSO was allowed for patients in the gefitinib or erlotinib arm upon centrally confirmed disease progression with confirmed EGFR T790M mutation

Primary endpoint: PFS by investigator assessment (RECIST v1.1)1

Secondary endpoints: Included OS, CNS PFS, ORR, DoR, DCR, safety3,6

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Baseline demographics1

Characteristic Percentage of patients

Median age

64 years (range 26-93)

Female

63%

White/Asian

36%/62%

Never smokers

64%

WHO PS 0-1

100%

Metastatic bone disease

36%

Extrathoracic visceral metastases

35%

CNS metastases

21%

116 patients (21%) in the FLAURA study had CNS metastases at study entry3†

References: 1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2021. 2. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. N Engl J Med. 2020;382(1):41-50. 3. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 4. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in untreated, EGFR-mutated advanced NSCLC. [protocol] N Engl J Med. 2020;382(1):41-50. 5. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non–small-cell lung cancer. [protocol] N Engl J Med. 2018;378(2):113-125. 6. Reungwetwattana T, Nakagawa K, Cho BC, et al. CNS response to osimertinib versus standard epidermal growth factor receptor tyrosine kinase inhibitors in patients with untreated EGFR-mutated advanced non–small-cell lung cancer. J Clin Oncol. 2018;36(33):3290-3297.