TAGRISSO (osimertinib)

TAGRISSO is an EGFR TKI indicated as a monotherapy for:

First-line TAGRISSO

FLAURA study design

FLAURA is a phase III, randomised, double-blind, international trial comparing TAGRISSO versus first-generation TKIs, gefitinib and erlotinib, in 556 patients with EGFR mutated NSCLC:2

FLAURA study design
FLAURA study design

Baseline characteristics

TAGRISSO was studied across a broad population of patients with NSCLC in FLAURA.2

Baseline characteristics
Baseline characteristics

Efficacy

Overall survival

First-line TAGRISSO: The only treatment with median overall survival beyond 3 years1,4

In the FLAURA study progression free survival was the primary endpoint. Overall survival was a secondary endpoint

In a global Phase III study of advanced EGFRm NSCLC4

Statistically significant overall survival

Overall survival
Overall survival

Nearly 30% of patients were still being treated with first-line TAGRISSO at 3 years4

Duration of therapy

Duration of therapy
Duration of therapy

PFS

In the FLAURA trial, 1L TAGRISSO met its primary endpoint and delivered an unprecedented median PFS of 18.9 months versus 10.2 months in the first-generation TKIs gefitinib and erlotinib.2

Kaplan-Meier estimates of the duration of PFS by investigator assessment 2*

Kaplan-Meier estimates
Kaplan-Meier estimates
Subgroup analysis of PFS
Subgroup analysis of PFS

CNS efficacy

1L TAGRISSO reduced the risk of CNS progression by 52% (HR 0.48 (95% CI 0.26-0.86) p=0.014) (nominally significant) versus first-generation EGFR TKIs.5

CNS efficacy
CNS efficacy

Overall response rate

The ORR with 1L TAGRISSO was similar to first-generation EGFR TKIs:2

PFS per blinded independent central review (BICR) in patients with CNS metastases at baseline:2

Overall response rate
Overall response rate

Duration of response

1L TAGRISSO more than doubled median duration of response duration of response versus first-generation EGFR TKIs.2

Duration of response
Duration of response