AstraZeneca has reported positive results from the ADAURA Phase III trial of Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II, IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The global, placebo-controlled, randomised, double-blind study has enrolled 682 patients across more than 20 countries including the US, Europe, Asia, South America, and the Middle East.
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Patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy were administered with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.
The primary endpoint of the trial was DFS in Stage II and IIIA patients while key secondary endpoints included DFS in Stage IB, II and IIIA patients, and overall survival (OS) in both the primary and overall populations.
Tagrisso reduced death risk by 51% compared to placebo in both the primary analysis and the overall trial populations.
The study demonstrated a statistically significant and clinically meaningful improvement in OS against placebo in the adjuvant treatment.
AstraZeneca Oncology research and development executive vice-president Susan Galbraith: “Tagrisso cut the risk of death by more than half in the adjuvant setting, further establishing this transformative medicine as the backbone treatment for EGFR-mutated lung cancer.
“These results emphasise the importance of diagnosing patients with lung cancer early, testing for EGFR mutations and treating all those with an EGFR mutation with Tagrisso.”
Tagrisso is also being tested in Phase III trials in the neoadjuvant resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting (ADAURA2) and the Stage III locally advanced unresectable setting (LAURA).
