By Fineline Cube 
UK-based AstraZeneca (AZ, NASDAQ: AZN) announced the final overall survival (OS) results from the Phase III FLAURA2 study. The data demonstrate that osimertinib (Tagrisso) in combination with pemetrexed and platinum-based chemotherapy significantly outperformed osimertinib monotherapy. This combination therapy provided a statistically significant and clinically meaningful OS benefit in the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
Clinical Trial Results
Previously reported interim OS and median progression-free survival (PFS) data from the study showed that the combination regimen achieved the longest median PFS reported to date for this indication. The final OS analysis further solidifies osimertinib’s position as the foundational treatment for EGFR-mutated NSCLC.
Safety Profile
The incidence of adverse events (AEs) was slightly higher in the combination therapy group, primarily due to known chemotherapy-related AEs. However, the rate of treatment discontinuation due to AEs or targeted toxicities remained low in both arms of the trial.
Global Approval and Trial Details
The FLAURA2 trial enrolled 557 patients across over 150 centers in more than 20 countries. The primary endpoint was PFS, with overall survival as a key secondary endpoint. Currently, osimertinib in combination with chemotherapy has been approved for the first-line treatment of EGFR-mutated NSCLC in over 80 countries, including the United States, the European Union, China, and Japan.-Fineline Info & Tech