A Phase III trial evaluating AstraZeneca's Tagrisso lung cancer drug has met its primary endpoint in showing superior progression-free survival compared to standard chemotherapy.
The AURA3 randomized trial evaluated the efficacy and safety of Tagrisso as a 2nd-line treatment in over 400 patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy.
The drug also showed a safety profile consistent with previous trials.
Apart from PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy.
The company said it is fully assessing AURA3 data, including an analysis of overall survival (OS), is ongoing, with results due to be presented at an upcoming medical meeting.
AstraZeneca executive vice president of global medicines development and chief medical officer 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.”
Tagrisso 80mg once-daily tablet is the first medicine indicated to treat adult patients with locally-advanced or metastatic EGFR T790M mutation-positive NSCLC.
AstraZeneca is 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.
Tagrisso is also being assessed in NSCLC patients with and without brain metastases. The company presented encouraging data in a small cohort of patients with leptomeningeal disease.