Positive Tagrisso Data Boost AstraZeneca's Lung Cancer Ambitions

AstraZeneca's Phase III AURA3 trial has met its primary endpoint, demonstrating better progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomized trial assessed the efficacy and safety of Tagrisso (osimertinib) 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 (TKI) therapy. Tagrisso also demonstrated a safety profile consistent with previous trials.

"[This data] means that AstraZeneca can now move to file for full approval of this treatment in the US and Europe where we had previously been granted accelerated/conditional approvals, respectively, on the strength of early data," an AstraZeneca spokesperson told Scrip. "Moving to full approval is a high priority for AstraZeneca. Once we achieve this, many more patients in need will be able to access Tagrisso as a new standard of care