A Phase III trial assessing AstraZeneca's lung cancer drug Tagrisso has met its primary endpoint in showing superior progression-free survival compared to standard chemotherapy.
The AURA3 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 non-small cell lung cancer (NSCLC), whose disease had progressed following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.
Full data are to be unveiled at an upcoming medical conference, AZ said, but did also reveal that, in addition to PFS, the objective response rate, disease control rate and duration of response also achieved clinically meaningful improvement versus chemotherapy, while the drug's safety profile was also consistent with earlier findings.
"These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients," said Sean Bohen, AZ' chief medical officer. "We remain committed to exploring the potential of Tagrisso to further extend its reach and help meet patient need."
AZ said that its drug, once-daily pill, has been through one of the fastest development programmes ever - from start of clinical trials to approval in just over two and a half years.
It is cleared in the US, EU, Japan, Canada, Switzerland, Israel and Mexico as the first treatment for patients with EGFR T790M mutation-positive advanced NSCLC, with eligibility for treatment dependent on confirmation that the EGFR T790M mutation is present in the tumour.
In Europe, Tagrisso was the new first medicine to win clearance under the European Commission's expedited process, after Phase II studies showed an objective response rate of 66 percent and median progression-free survival of 9.7 months.