AstraZeneca announces results from FLAURA2 Phase III trial of TAGRISSO

Positive results from the final overall survival, OS, analysis of the FLAURA2 Phase III trial showed AstraZeneca’s (AZN) TAGRISSO with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to TAGRISSO monotherapy in the 1st-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer, NSCLC. In the final OS analysis, TAGRISSO plus chemotherapy demonstrated a median OS of nearly four years compared to approximately three years for TAGRISSO monotherapy. At 57% data maturity, results showed TAGRISSO plus chemotherapy reduced the risk of death by 23% compared to TAGRISSO monotherapy. An estimated 63.1% of patients treated with the combination were alive at three years and 49.1% of patients were alive at four years compared to 50.9% and 40.8%, respectively, in the monotherapy arm. Importantly, the observed OS benefit for TAGRISSO plus chemotherapy versus TAGRISSO monotherapy was consistent across all prespecified subgroups. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the relevance of the OS results.