PFS

First-line TAGRISSO delivered a superior 18.9 months median PFS vs 10.2 months for the EGFR TKI comparator arm1,2

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)1,2
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SUBGROUPS

First-line TAGRISSO delivered a consistent PFS benefit (HR <0.6) across all prespecified subgroups1,2

  • Including in patients with or without CNS metastases2
  • And in patients with exon 19 deletion or L858R1,2
SAFETY SAFETY
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CNS

First-line TAGRISSO reduced the risk of CNS progression by 52%1

CNS PFS per BICR in patients with CNS metastases at baseline1,3

CNS CNS

Fewer patients on TAGRISSO progressed due to new CNS lesions vs the EGFR TKI comparator arm3

CNS CNS
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OS

First-line TAGRISSO reduced the risk of death by 37% at the interim OS analysis1,2*

OS OS
OS
  • Crossover to second-line TAGRISSO from the EGFR TKI comparator arm was allowed for patients with confirmed progression and the EGFR T790M mutation1
OS
  • Crossover to second-line TAGRISSO from the EGFR TKI comparator arm was allowed for patients with confirmed progression and the EGFR T790M mutation1
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DoR/ORR

First-line TAGRISSO more than doubled median duration of response vs the EGFR TKI comparator arm1

DoR DoR

Objective response rates in the FLAURA study

ORR ORR
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STUDY DESIGN

First-line TAGRISSO was studied in FLAURA, a Phase III, randomised, double-blind, international trial vs the EGFR TKI comparator arm1,2,4

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

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

Secondary endpoints: included ORR, DoR, DCR, OS, safety1,2

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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 trial had CNS metastases at study entry2*

References:
1. AstraZeneca Pharmaceuticals. TAGRISSO® (osimertinib). Summary of Product Characteristics, 2018. 2. 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;378:113-125. 3. Vansteenkiste J, Reungwetwattana T, Nakagawa K, et al. CNS response to osimertinib vs standard-of-care EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC: FLAURA. Presented at ESMO Asia, November 2017, Suntec City, Singapore. Abstract LBA5. 4. Soria J-C, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non–small-cell lung cancer. N Engl J Med. 2018;378:113-125 [study protocol]. doi:10.1056/NEJMoa1713137. www.nejm.org/doi/full/10.1056/NEJMoa1713137. Accessed February 1, 2018.