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Osimertinib is a potent, irreversible epidermal growth factor receptor ( EGFR ) tyrosine kinase inhibitor ( TKI ) selective for  EGFR ‑ TKI  sensitizing ( EGFR m) and T790M resistance mutations. The primary objective of the cytology cohort in the  AURA  study was to investigate safety and efficacy of osimertinib in pretreated Japanese patients with   EGFR   T790M mutation‐positive non‐small cell lung cancer ( NSCLC ), with screening   EGFR   T790M mutation status determined from cytology samples. The cytology cohort was included in the Phase I dose expansion component of the  AURA  study. Patients were enrolled based on a positive result of T790M by using cytology samples, and received osimertinib 80 mg in tablet form once daily until disease progression or until clinical benefit was no longer observed at the discretion of the investigator. Primary endpoint for efficacy was objective response rate ( ORR ) by investigator assessment. Twenty‐eight Japanese patients were enrolled into the cytology cohort. At data cut‐off (February 1, 2016), 12 (43%) were on treatment. Investigator‐assessed  ORR  was 75% (95% confidence interval [ CI ] 55, 89) and median duration of response was 9.7 months (95%  CI  3.8, not calculable [ NC ]). Median progression‐free survival was 8.3 months (95%  CI  4.2,  NC ) and disease control rate was 96% (95%  CI  82, 100). The most common all‐causality adverse events were paronychia (46%), dry skin (46%), diarrhea (36%) and rash (36%). Osimertinib provided clinical benefit with a manageable safety profile in patients with pretreated   EGFR   T790M mutation‐positive  NSCLC  whose screening   EGFR   T790M mutation‐positive status was determined from cytology samples. (ClinicalTrials.gov number  NCT 01802632).

Osimertinib in patients with epidermal growth factor receptor T790M advanced non‐small cell lung cancer selected using cytology samples