OS

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

In a global Phase III study of advanced EGFRm NSCLC2

OS OS

3-year survival was 54% on first-line TAGRISSO vs 44% on gefitinib/erlotinib1

Nearly 30% of patients were still being treated with first-line TAGRISSO at 3 years1

OS OS

At the time of DCO, 22% of patients remained on first-line TAGRISSO vs 5% for gefitinib/erlotinib.1

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PFS

First-line TAGRISSO delivered an unprecedented 18.9 months median PFS2,3

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)2,3
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PFS SUBGROUPS

First-line TAGRISSO demonstrated a consistent PFS benefit (HR <0.6) across all prespecified subgroups2,3

  • 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

CNS PFS per BICR in patients with CNS metastases at baseline2,5

CNS CNS

Fewer patients on TAGRISSO progressed due to a new CNS lesions vs gefitinib/erlotinib5

CNS CNS
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STUDY DESIGN

First-line TAGRISSO was studied in FLAURA, a global, Phase III, double-blind, randomised study vs gefitinib/erlotinib2-4

STUDY DESIGN STUDY 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)2

Secondary endpoints: included OS, CNS PFS, ORR, DoR, DCR, safety3,5

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Baseline demographics2

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. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis [oral presentation]. Presented at: European Society of Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA5. 2. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2019. 3. Soria J-C, 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. Soria J-C, 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 [protocol]. 5. 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 [published online August 28, 2018]. J Clin Oncol. doi:10.1200/JCO.2018.78.3118.