The ADAURA Phase III trial for osimertinib in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with complete tumour resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy.
José Baselga, Executive Vice President, Oncology R&D, said: “We are thrilled by the recommendation to unblind the Phase III ADAURA trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure.”
The primary endpoint of the Phase III ADAURA trial is disease-free survival (DFS). Osimertinib was assessed against placebo for a treatment duration of up to three years. The trial will continue to assess the secondary endpoint of overall survival. In its communication to AstraZeneca, the IDMC did not raise any new safety concerns. The data will be presented at a forthcoming medical meeting.