A phase 3 trial designed to compare osimertinib with standard first-line therapy for non-small cell lung cancer met its primary endpoint of improved PFS, according to the drug’s manufacturer.
The double-blind, randomized phase 3 FLAURA trial compared the efficacy, safety and tolerability of osimertinib (Tagrisso, AstraZeneca), an irreversible EGFR tyrosine kinase inhibitor, with standard first-line therapy in 556 treatment-naive patients with locally advanced or metastatic EGFR-positive NSCLC.
Patients received 80 mg osimertinib once daily, 150 mg oral erlotinib (Tarceva; Genentech, Astellas) once daily, or 250 mg oral gefitinib (Iressa, AstraZeneca) once daily.
PFS served as the primary endpoint. Secondary endpoints included OS, objective response rate, duration of response, disease control rate, safety and health-related quality of life.
Patients in the osimertinib arm demonstrated a statistically significant and clinically meaningful PFS benefit compared with those who received standard treatment.
The efficacy, safety and tolerability profiles of each treatment appeared consistent with prior studies, according to an AstraZeneca-issued press release.
A full evaluation of FLAURA data is ongoing.
“The strong results from the FLAURA trial are very exciting news for patients with EGFR mutation-positive NSCLC, providing physicians with a potential new first-line treatment option to improve outcomes in this disease,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in the release. “We will now initiate discussions with global health authorities on the data and regulatory submissions.”