AstraZeneca's Tagrisso Hits Primary Endpoint in Phase 3 Lung Cancer Trial

AstraZeneca announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed following 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials.

In addition to PFS, the objective response rate (ORR), disease control rate (DCR) and duration of response (DoR) also achieved clinically meaningful improvement versus chemotherapy. A full evaluation of AURA3 data, including an analysis of overall survival (OS), is ongoing, and results will be presented at an upcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer. We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need.”

Tagrisso is one of the fastest development programmes 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 advanced 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 tumour.

AstraZeneca is committed to exploring the full potential of Tagrisso as monotherapy and in combination, for patients with lung cancer, including in adjuvant and locally-advanced/ metastatic 1st-line EGFRm settings. In addition, AstraZeneca is exploring Tagrisso in NSCLC patients with and without brain metastases, and has presented encouraging data in a small cohort of patients with leptomeningeal disease.