Findings from the phase 3 FLAURA study evaluating osimertinib (Tagrisso; AstraZeneca) as a first-line therapy in adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) showed that the treatment was associated with a statistically significant and clinically meaningful improvement in overall survival.

In the FLAURA study, the safety and efficacy of osimertinib was compared with standard of care EGFR-tyrosine kinase inhibitors (gefitinib, erlotinib). In 2017, the trial met its primary end point showing significant improvement in progression-free survival with osimertinib. 

An analysis of key secondary end points showed that treatment with osimertinib was associated with a median overall survival of 38.6 months compared with 31.8 months in the comparator group. In addition, 28% of osimertinib-treated patients remained on their treatment at 3 years vs 9% of patients on gefitinib or erlotinib. Moreover, osimertinib treatment resulted in a 52% reduction in the risk of CNS disease progression (HR 0.48; 95% CI, 0.26-0.86; P =.014). 

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“The results of the FLAURA trial provide further evidence to support the role of osimertinib as the preferred 1st-line therapy option for patients with EGFR-mutated non-small cell lung cancer,” said Dr Suresh S. Ramalingam, Principal Investigator of the FLAURA trial from Winship Cancer Institute of Emory University, Atlanta, US. 


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