TAGRISSO™▼ (osimertinib)
TAGRISSO is an EGFR TKI indicated as a monotherapy for:
Second-line TAGRISSO
AURA3 study design
AURA3 was a Phase Ill, randomised, international, open-label study comparing TAGRISSO with platinum-pemetrexed in 419 patients with EGFR T790M mutation-positive NSCLC who had disease progression on 1L EGFR-TKI therapy:9-11
- Primary endpoint: PFS (by investigator assessment)
- Secondary endpoints: ORR, DoR, OS, DCR, tumour shrinkage, health-related quality of life (HRQoL), and safety
Inclusion criteria:9-10
- Locally-advanced or metastatic NSCLC
- Radiological documentation of disease following 1st-line EGFR TKI treatment without any further treatment
- At least one lesion, not previously irradiated
- Eligible to receive treatment with platinum-pemetrexed
- Central confirmation of T790M+ mutation status
- World Health Organization performance status 0–1