AstraZeneca has reported positive results from the Phase III FLAURA trial of Tagrisso (osimertinib) to treat patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC).
The trial has met the primary endpoint of statistically significant and clinically meaningful progression-free survival (PFS) in previously untreated patients who were epidermal growth factor receptor mutation (EGFRm) positive.
Tagrisso is an irreversible EGFR tyrosine kinase inhibitor (TKI) currently being developed to inhibit EGFR sensitising and EGFR T790M resistance mutations.
The double-blinded, randomised Phase III trial compared the efficacy and safety of 80mg once-daily Tagrisso with standard-of-care EGFR-TKIs, oral once-daily 150mg of erlotinib and 250mg once-daily oral gefitinib in a total of 556 subjects across 30 countries.
AstraZeneca global medicines development executive vice-president and chief medical officer Sean Bohen said: “The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive non-small-cell lung cancer, providing physicians with a potential new first-line treatment option to improve outcomes in this disease.
“We will now initiate discussions with global health authorities on the data and regulatory submissions.”
The FLAURA trial’s primary endpoint was PFS, while secondary endpoints comprised safety, overall survival, objective response rate, duration of response, disease control rate and measures of health-related quality of life (HRQoL).
During the trial period, the efficacy, safety and tolerability of Tagrisso, erlotinib and gefitinib were observed to be consistent with their documented profiles.
AstraZeneca also reported that the combination of its Imfinzi with tremelimumab did not meet the primary endpoint during interim analysis of the Phase III MYSTIC trial conducted in collaboration with MedImmune for previously untreated metastatic first-line NSCLC patients.