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Presidential Symposium I

4738 - Osimertinib vs standard of care (SoC) EGFR-TKI as first-line therapy in patients (pts) with EGFRm advanced NSCLC: FLAURA


09 Sep 2017


Presidential Symposium I


Suresh Ramalingam


Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440


S. Ramalingam1, T. Reungwetwattana2, B. Chewaskulyong3, A. Dechaphunkul4, K.H. Lee5, F. Imamura6, N. Nogami7, Y. Ohe8, Y. Cheng9, B.C. Cho10, E.K. Cho11, J.F. Vansteenkiste12, P.J. Voon13, C. Zhou14, J. Gray15, R. Hodge16, Y. Rukazenkov17, J. Soria18

Author affiliations

  • 1 Winship Cancer Institute, Emory University, 30322 - Atlanta/US
  • 2 Faculty Of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok/TH
  • 3 Oncology Unit, Department Of Medicine, Chiang Mai University, Chiang Mai/TH
  • 4 Internal Medicine, Division Of Medical Oncology, Prince of Songkla University, Hat-Yai/TH
  • 5 Division Of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, 218644 - Cheongju/KR
  • 6 Department Of Thoracic Oncology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
  • 7 Department Of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 8 Department Of Internal Medicine, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 9 Medical Oncology, Jilin Cancer Hospital, Jilin/CN
  • 10 Division Of Medical Oncology, Department Of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Yonsei/KR
  • 11 Division Of Hematology And Oncology, Department Of Internal Medicine, Gachon University Gil Medical Center, Inchon/KR
  • 12 Respiratory Oncology Unit (pulmonology), University Hospital KU Leuven, 3000 - Leuven/BE
  • 13 Radiotherapy And Oncology, Hospital Umum Sarawak, Kuching/MY
  • 14 Department Of Oncology, Shanghai Pulmonary Hospital, Tongji University, 200433 - Shanghai/CN
  • 15 Department Of Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa/US
  • 16 Biostatistics And Informatics, AstraZeneca, Cambridge/GB
  • 17 Research And Development, Astrazeneca, Cambridge/GB
  • 18 Department Of Drug Development, Gustave Roussy Cancer Campus and University Paris-Sud, 94800 - Villejuif/FR


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Abstract 4738


Osimertinib is a third-generation, CNS-active EGFR-TKI that potently and selectively inhibits both EGFRm and EGFR T790M resistance mutations. Pre- and early clinical data suggest osimertinib may also be effective as initial therapy for EGFRm advanced NSCLC. FLAURA (NCT02296125) is a PhIII, double-blind, randomised study assessing efficacy and safety of osimertinib vs SoC EGFR-TKI in first-line pts with EGFRm advanced NSCLC.


Eligible pts: ≥18 years, no prior EGFR-TKI/systemic anti-cancer therapy for advanced disease, with Ex19del/L858R EGFRm advanced NSCLC. Neurologically stable pts with CNS mets were allowed, provided definitive treatment/steroids were completed for ≥2 weeks. Pts were randomised 1:1 to osimertinib 80 mg once daily (qd) orally (po) or SoC EGFR-TKI (gefitinib 250 mg or erlotinib 150 mg qd po), stratified by mutation status (Ex19del/L858R) and race (Asian/non-Asian). Primary endpoint: progression-free survival (PFS) by RECIST v1.1, by investigator. Data cut-off: 12 June 2017.


Globally, 556 pts were randomised to treatment. Baseline characteristics were balanced across arms (osimertinib/SoC): female 64/62%; Asian 62/62%, Ex19del 57/56%, L858R 35/32%, CNS mets 19/23%.Table:


Efficacy endpointOsimertinibSoC
n = 279n = 277
PFS hazard ratio (HR)0.46 (0.37, 0.57); p 


Osimertinib demonstrated a superior risk/benefit over SoC as first-line therapy in pts with advanced EGFRm NSCLC.

Clinical trial identification


Legal entity responsible for the study





S. Ramalingam: Advisory Board Meeting for: Astra Zeneca, Bristol-Myers Squibb, Genentech, Boehringer-Ingelheim. F. Imamura: Research fund and honoraria from AstraZeneca. N. Nogami: Funding from AstraZeneca. Y. Ohe: Honorarium/Consultant/Expert Testimony/Research Funding (Institution); AstraZeneca, Chugai, Lilly, ONO, BMS, Daiichi-Sankyo, Nippon Kayaku, Boehringer, Bayer, Pfizer, MSD, Taiho, Clovis, Sanofi, Novartis, Kyorin, Dainippon-Sumitomo, Merck. J.F. Vansteenkiste: Grants/research support: AstraZeneca Honoraria/consultation fees: AstraZeneca, Novartis, MSD, Boehringer-Ingelheim, Eli-Lilly, Roche. C. Zhou: Lecture honorarium: Eli Lily, AstraZeneca, Roche, Pfizer, Sanofi, Boehringer-Ingelheim, Henrui Advisory Board: Roche, Boehringer-Ingelheim, AstraZeneca. J. Gray: Consultant/Advisory Boards: AstraZeneca, Celgene, Eli Lilly, Janssen, Boehringer-Ingelheim, Clovis. Research Funding: Array, AstraZeneca, Merck, Trovagene. R. Hodge, Y. Rukazenkov: Employee of, and shareholder in, AstraZeneca. J-C. Soria: Consultancy fees for AstraZeneca, Roche. All other authors have declared no conflicts of interest.

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