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However, almost all patients develop resistance after approximately 1\u00a0y of treatment, with &gt;50% of cases due to the T790M secondary mutation of the EGFR gene. A large global Phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> study (<jats:styled-content style=\"fixed-case\">AURA<\/jats:styled-content>3) demonstrated that osimertinib significantly prolonged progression\u2010free survival (<jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content>) over platinum\u2010doublet chemotherapy in patients with T790M\u2010positive <jats:styled-content style=\"fixed-case\">NSCLC<\/jats:styled-content> who had progressed on previous <jats:styled-content style=\"fixed-case\">EGFR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">TKI<\/jats:styled-content> 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\u2010planned subgroup analysis of pooled Phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> data from the <jats:styled-content style=\"fixed-case\">AURA<\/jats:styled-content> Extension and <jats:styled-content style=\"fixed-case\">AURA<\/jats:styled-content>2 trials to investigate the efficacy and safety of osimertinib in Japanese patients. This study included 81 Japanese patients. Patients were administered 80\u00a0mg osimertinib orally once daily until disease progression. The main endpoints were objective response rate (<jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>), <jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content>, and safety. The <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 63.6% and median <jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content> was 13.8\u00a0mo. Overall survival rate at 36\u00a0mo was 54.0%. The most common all\u2010cause 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 <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were grade 1\u20102. Five patients (6.2%) developed interstitial lung disease, resulting in two deaths (2.5%). Osimertinib demonstrated favorable <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content> in Japanese patients, similar to the overall population. Additionally, osimertinib has good efficacy and a manageable safety profile in Japanese patients with <jats:styled-content style=\"fixed-case\">NSCLC<\/jats:styled-content> who had acquired resistance due to the T790M mutation.<\/jats:p>","DOI":"10.1111\/cas.14120","type":"journal-article","created":{"date-parts":[[2019,7,2]],"date-time":"2019-07-02T15:05:45Z","timestamp":1562079945000},"page":"2884-2893","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Osimertinib for Japanese patients with T790M\u2010positive advanced non\u2010small\u2010cell lung cancer: A pooled subgroup analysis"],"prefix":"10.1111","volume":"110","author":[{"given":"Tomonori","family":"Hirashima","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology Osaka Habikino Medical Center Habikino\u2010city, Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miyako","family":"Satouchi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Hyogo Cancer Center Akashi Hyogo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3537-0020","authenticated-orcid":false,"given":"Toyoaki","family":"Hida","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Aichi Cancer Center Hospital Chikusa\u2010ku, Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4969-4165","authenticated-orcid":false,"given":"Makoto","family":"Nishio","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto\u2010ku, Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Terufumi","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Kanagawa Cardiovascular and Respiratory Center Kanazawa\u2010ku, Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Saitama Cancer Center, Ina Kita\u2010adachi\u2010gun, Saitama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fumio","family":"Imamura","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Osaka International Cancer Institute Chuo\u2010ku, Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuyuki","family":"Kiura","sequence":"additional","affiliation":[{"name":"Department of Allergy and Respiratory Medicine Okayama University Hospital Kita\u2010ku, Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7587-6096","authenticated-orcid":false,"given":"Isamu","family":"Okamoto","sequence":"additional","affiliation":[{"name":"Research Institute for Diseases of the Chest Graduate School of Medical Sciences Kyushu University Higashi\u2010ku, Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuo","family":"Kasahara","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Kanazawa University Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences Kanazawa, Ishikawa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirohiko","family":"Uchida","sequence":"additional","affiliation":[{"name":"Research and Development AstraZeneca K.K. 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