• 1 Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. Electronic address:
  • 2 Oncology Unit, Department of Medicine, Chiang Mai University, Chiang Mai, Thailand
  • 3 Division of Medical Oncology, Chungbuk National University Hospital, Cheong-ju, Republic of Korea
  • 4 Division of Medical Oncology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
  • 5 Division of Medical Oncology, Department of Medicine, Chulalongkorn University and the King Chulalongkorn Memorial Hospital, Bangkok, Thailand
  • 6 Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan
  • 7 Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan
  • 8 Department of Thoracic Oncology, Kansai Medical University Hospital, Osaka, Japan
  • 9 Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University Hospital, Fukuoka, Japan
  • 10 Department of Oncology, Shanghai Pulmonary Hospital of Tongji University, Shanghai, People's Republic of China
  • 11 Division of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun, People's Republic of China
  • 12 Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea
  • 13 Radiotherapy and Oncology Department, Hospital Umum Sarawak, Kuching, Malaysia
  • 14 Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
  • 15 Global Medicines Development, AstraZeneca, Cambridge, United Kingdom
  • 16 Division of Medical Oncology, Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand
  • 17 Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University School of Medicine, Atlanta, Georgia
  • 18 Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
J Thorac Oncol, 2019 01;14(1):99-106.
PMID: 30240852 DOI: 10.1016/j.jtho.2018.09.004


INTRODUCTION: Here we report efficacy and safety data of an Asian subset of the phase III FLAURA trial (NCT02296125), which compares osimertinib with standard of care (SoC) EGFR tyrosine kinase inhibitors (TKIs) in patients with previously untreated advanced NSCLC with tumors harboring exon 19 deletion (Ex19del)/L858R EGFR TKI-sensitizing mutations.

METHODS: Eligible Asian patients (enrolled at Asian sites) who were at least 18 years of age (≥20 years in Japan) and had untreated EGFR-mutated advanced NSCLC were randomized 1:1 to receive osimertinib (80 mg, orally once daily) or an SoC EGFR TKI (gefitinib, 250 mg, or erlotinib, 150 mg, orally once daily). The primary end point was investigator-assessed progression-free survival (PFS). The key secondary end points were overall survival, objective response rate, central nervous system efficacy, and safety.

RESULTS: The median PFS was 16.5 versus 11.0 months for the osimertinib and SoC EGFR TKI groups, respectively (hazard ratio = 0.54, 95% confidence interval: 0.41-0.72, p < 0.0001). The overall survival data were immature (24% maturity). The objective response rates were 80% for osimertinib and 75% for an SoC EGFR TKI. The median central nervous system PFS was not calculable for the osimertinib group and was 13.8 months for the SoC EGFR TKI group (hazard ratio = 0.55, 95% confidence interval: 0.25-1.17, p = 0.118). Fewer adverse events of grade 3 or higher (40% versus 48%) and fewer adverse events leading to treatment discontinuation (15% versus 21%) were reported with osimertinib versus with an SoC EGFR TKI, respectively.

CONCLUSION: In this Asian population, first-line osimertinib demonstrated a clinically meaningful improvement in PFS over an SoC EGFR TKI, with a safety profile consistent with that for the overall FLAURA study population.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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