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Epidermal growth factor receptor ( EGFR )‐tyrosine kinase inhibitors ( TKI s) are the standard of care for non‐small‐cell lung cancer ( NSCLC ) patients harboring EGFR mutations. However, almost all patients develop resistance after approximately 1 y of treatment, with >50% of cases due to the T790M secondary mutation of the EGFR gene. A large global Phase  III  study ( AURA 3) demonstrated that osimertinib significantly prolonged progression‐free survival ( PFS ) over platinum‐doublet chemotherapy in patients with T790M‐positive  NSCLC  who had progressed on previous  EGFR ‐ TKI  therapy. However, it is not clear whether efficacy or safety of osimertinib in Japanese patients is similar to the overall population. We report a pre‐planned subgroup analysis of pooled Phase  II  data from the  AURA  Extension and  AURA 2 trials to investigate the efficacy and safety of osimertinib in Japanese patients. This study included 81 Japanese patients. Patients were administered 80 mg osimertinib orally once daily until disease progression. The main endpoints were objective response rate ( ORR ),  PFS , and safety. The  ORR  was 63.6% and median  PFS  was 13.8 mo. Overall survival rate at 36 mo was 54.0%. The most common all‐cause adverse events (AEs) were rash (grouped term; 65.4%), diarrhea (51.9%), paronychia (grouped term; 49.4%), and dry skin (grouped term; 39.5%). Most  AE s were grade 1‐2. Five patients (6.2%) developed interstitial lung disease, resulting in two deaths (2.5%). Osimertinib demonstrated favorable  ORR  and  PFS  in Japanese patients, similar to the overall population. Additionally, osimertinib has good efficacy and a manageable safety profile in Japanese patients with  NSCLC  who had acquired resistance due to the T790M mutation.

Osimertinib for Japanese patients with T790M‐positive advanced non‐small‐cell lung cancer: A pooled subgroup analysis