Osimertinib is a third-generation EGFR-TKI indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who progressed after first-line targeted therapy. The phase III FLAURA study assessed the efficacy and safety of osimertinib (80mg once daily) versus standard-of-care EGFR TKI therapy with gefitinib (250mg once daily) or erlotinib (150mg once daily). The trial recruited 556 treatment-naïve patients with EGFR exon 19 deletion or L858R EGFR mutation advanced NSCLC. The results of the trial showed that osimertinib was superior to current therapies (primary endpoint: median progression-free survival: 18.9 months vs. 10.2 months; P<0.001), suggesting that osimertinib could be a suitable first-line treatment for advanced EGFR mutation-positive NSCLC patients in the future.

Soria JC, et al. N. Engl. J. Med. 378, 113–125 (2018)