AstraZeneca presents OS results from Phase III FLAURA trial of TAGRISSO
AstraZeneca presented detailed overall survival results from the Phase III FLAURA trial of TAGRISSO in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer. Results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint for TAGRISSO versus gefitinib or erlotinib, both of which were previous standard-of-care treatments in this setting. TAGRISSO delivered a median OS of 38.6 months versus 31.8 months for the comparator arm. At three years, 28% of patients in the TAGRISSO arm and 9% of patients in the comparator arm remained on 1st-line study treatment. TAGRISSO also showed a statistically significant and clinically meaningful 52% reduction in the risk of central nervous system disease progression, increasing the time patients with CNS metastases lived without CNS disease progression or death. In the FLAURA trial, the safety and tolerability of TAGRISSO was consistent with its established profile. TAGRISSO was generally well tolerated, with Grade 3 or higher adverse events occurring in 42% of patients taking TAGRISSO versus 47% in the comparator arm. The FLAURA trial met its primary endpoint in July 2017, showing a statistically significant and clinically meaningful improvement in PFS, increasing the time patients lived without disease progression or death from any cause. TAGRISSO is currently approved in 78 countries, including the U.S., Japan, China and the EU, for 1st-line EGFR-mutated metastatic NSCLC.