AstraZeneca Announces Positive Phase III FLAURA2 Trial Results for Osimertinib Combined with Chemotherapy in First-Line EGFR-Mutated NSCLC

On May 17, AstraZeneca announced positive results from the Phase III Flaura2 study of the third-generation EGFR inhibitor osimertinib in combination with chemotherapy for the treatment of non-small cell lung cancer (NSCLC) patients with EGFR mutations.

Flaura2 is a global, multicenter, randomized, open-label clinical trial that enrolled 586 patients. It aims to evaluate the efficacy and safety of osimertinib with or without chemotherapy (pemetrexed + cisplatin/carboplatin) as first-line treatment for patients with locally advanced (stage IIIB-III) or metastatic (stage IV) NSCLC carrying EGFR mutations. The primary endpoint of the study is progression-free survival (PFS).

High-level positive results show that, compared with the osimertinib monotherapy group, PFS in patients of the osimertinib combined with chemotherapy group was significantly and clinically prolonged. At the time of this analysis, overall survival (OS) data were not yet mature and will be formally assessed in subsequent analyses. Safety data and discontinuation rates due to adverse events were consistent with prior study data for each drug.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, stated: "These significant FLAURA2 results demonstrate that osimertinib has the potential to provide a new first-line treatment option for patients, helping to extend their survival time without disease progression. This meaningful outcome builds on a series of clinical trials, with multiple previous studies already showing that osimertinib can improve clinical benefits for patients with EGFR-mutated lung cancer."

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