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Front-Line Osimertinib Improves Overall Survival in EGFR-Mutation Positive NSCLC

(ESMO 2019) Sept 28, 2019 - First-line osimertinib significantly lengthens overall survival compared to older generation EGFR-TKIs in patients with Ex19del/L858R EGFR mutated advanced non–small cell lung cancer (NSCLC), according to late breaking results of the FLAURA trial presented at the ESMO Congress 2019 in Barcelona, Spain. (1) The primary endpoint of progression free survival (PFS) was previously reported. (2) Survival data are now mature: the median overall survival with osimertinib was 38.6 months versus 31.8 months with first generation EGFR-TKIs, with a hazard ratio of 0.799 (p=0.0462). More than half (54%) of patients in the osimertinib group were alive at three years compared to 44% in the standard care group.

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H. Jack West, MD (Posted: October 01, 2019)

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An important result that should satisfy the holdouts who were waiting on a demonstrated improvement in overall survival while considering the potential utility of a sequential approach. The trial has a few flaws, most notably not requiring a baseline MRI and not requiring treatment of detected brain mets -- both factors that clearly benefit the osimertinib arm -- and the rate of subsequent therapies is conspicuously lower than expected. Nevertheless, the efficacy, tolerability, and CNS activity of osimertinib are all very favorable, and the biggest limitation in its global use is the aggressive pricing, which precludes its availability for many EGFR mutation-positive patients around the world and makes it a financial challenge for many of those who can access it.

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