AstraZeneca announces results from FLAURA2 trial

Results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, or PFS, compared to Tagrisso alone for patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer, or NSCLC. These results were presented in a Presidential Symposium at the International Association for the Study of Lung Cancer, or IASLC, 2023 World Conference on Lung Cancer, or WCLC. Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone. By investigator assessment, the combination extended median PFS by 8.8 months versus Tagrisso alone. PFS results from blinded independent central review, or BICR, were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months. Importantly, a clinically meaningful PFS benefit was observed across all prespecified subgroups, including sex, race, type of EGFR mutation, age at time of diagnosis, smoking history and central nervous system, or CNS, metastasis status at baseline. At the time of this analysis, the overall survival, or OS, data were immature however, a favorable trend was observed for Tagrisso plus chemotherapy. Safety results and discontinuation rates due to adverse events, or AEs, were consistent with the established profiles of each medicine and no new safety concerns were reported. Grade 3 or higher AEs from all causes occurred in 64% of patients in the Tagrisso plus chemotherapy arm versus 27% in the Tagrisso monotherapy arm.