Astrazeneca Says Tagrisso Met Primary Endpoint In Phase III AURA3 Trial
AstraZeneca (AZN) announced that the AURA3 Phase III trial met its primary endpoint, demonstrating superior progression-free survival compared to standard platinum-based doublet chemotherapy. The AURA3 randomized trial assessed the efficacy and safety of TAGRISSO as a second-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following first-line EGFR tyrosine kinase inhibitor therapy.
TAGRISSO also demonstrated a safety profile consistent with previous trials. In addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy. A full evaluation of AURA3 data, including an analysis of overall survival, is ongoing, and results will be presented at an upcoming medical meeting.
TAGRISSO is one of the fastest development programs ever, from start of clinical trials to approval in just over two and a half years. It was approved in the US, EU, Japan, Canada, Switzerland, Israel, and Mexico as the first treatment for patients with EGFR T790M mutation-positive locally advanced/metastatic NSCLC.
TAGRISSO is also approved in South Korea in the same indication. Eligibility for treatment with TAGRISSO is dependent on confirmation that the EGFR T790M mutation is present in the tumor. AstraZeneca is committed to exploring the full potential of TAGRISSO along with the rest of our outstanding oncology portfolio.
Disclosure: None.