AstraZeneca celebrates success in latest Tagrisso trial

AstraZeneca announced on Monday that the Phase III AURA3 trial has met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy.

The FTSE 100 pharmaceutical giant said the AURA3 randomised 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 non-small cell lung cancer, whose disease had progressed following first-line EGFR tyrosine kinase inhibitor therapy.

Tagrisso also demonstrated a safety profile consistent with previous trials, the company reported.

“These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients,” said AstraZeneca’s executive vice president, global medicines development and chief medical officer Sean Bohen.

“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,” Bohen added.

AstraZeneca said that in addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically-meaningful improvement against chemotherapy.

A full evaluation of AURA3 data, including an analysis of overall survival, is ongoing, with results to be presented at an “upcoming medical meeting”, the firm’s board said.