TAGRISSO (osimertinib)

TAGRISSO (osimertinib) is an EGFR TKI indicated for adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC).1

Clinical trials

Efficacy

In the AURA3 clinical trial, TAGRISSO demonstrated superior efficacy vs. platinum pemetrexed2

Progression-free survival:
In the 279 patients administered TAGRISSO, median progression-free survival was more than twice as long as those taking platinum pemetrexed.2

Kaplan-Meier estimates
Kaplan-Meier estimates

Study design

AURA3 was a Phase III, randomised, international, open-label study comparing TAGRISSO with platinum-pemetrexed in 419 patients with EGFR T790M Mutation-positive NSCLC who had progressed on first-line TKI therapy.2

Primary endpoint: Progression-free survival.2
Secondary endpoints: Objective Response Rate (ORR), Duration of response (DoR), Overall Survival (OS), Disease Control Rate (DCR), Tumour Shrinkage, Health-related Quality of Life (HRQoL) and safety.2

Study design
Study design

* cobas® EGFR Mutation Test v2 (Roche Molecular Systems).2
Platinum-pemetrexed (every 3 weeks for up to 6 cycles of pemetrexed 500 mg/m2 plus either carboplatin AUC5 or cisplatin 75 mg/m2) Patients whose disease had not progressed after 4 cycles of platinum pemetrexed could continue maintenance pemetrexed according to the approved label.2
Patients could receive study treatment beyond RECIST-defined progression as long as they experienced clinical benefit, as judged by the investigator.2
§ In the platinum-pemetrexed group, 60% (n=82) of patients crossed over to receive TAGRISSO. Patients on platinum-pemetrexed could cross over to TAGRISSO after BICR-confirmed progression.2

Inclusion criteria:2

  • 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

Baseline demographics:2

Exclusion criteria
Exclusion criteria