Tagrisso Phase III ADAURA trial to be unblinded on showing 'overwhelming' efficacy

The ADAURA Phase III trial for Tagrisso (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 tumor resection will be unblinded early following a recommendation from an Independent Data Monitoring Committee (IDMC) based on its determination of overwhelming efficacy, according to AstraZeneca (LSE: ZN), whose shares closed up 2.15% at £71.21 on the news ahead of the Easter holiday.

José Baselga, executive vice president, oncology R&D at AstraZeneca, 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."

Plans for regulatory submissions in this indication are already underway, the company noted. Tagrisso is already a growth-driver for AstraZeneca, which posted full-year 2019 sales of the drug at $3.19 billion, a year-on-year rise of 74% at constant exchange rates, with fourth-quarter revenues up 49% at $884 million.