AstraZeneca's study of its lung cancer treatment Tagrisso will be unblinded early following a recommendation from an Independent Data Monitoring Committee based on its determination of "overwhelming efficacy."
ADAURA is the first global trial for an EGFR inhibitor to show statistically significant and clinically meaningful benefit in adjuvant treatment of lung cancer. The global Phase III trial of 682 patients assessed Tagrisso against placebo 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.
The result that could significantly expand the use of the drugmaker's blockbuster drug, which already has approval in 80 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 87 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC.
"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," said José Baselga, Executive Vice President, Oncology R&D.
Plans for regulatory submission already underway.
Read the press release
