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Proffered paper session 1

2131 - Osimertinib vs standard of care EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC: FLAURA (413O)


18 Nov 2017


Proffered paper session 1


Yuichiro Ohe


Annals of Oncology (2017) 28 (suppl_10): x124-x143. 10.1093/annonc/mdx671


Y. Ohe1, S. Ramalingam2, T. Reungwetwattana3, B. Chewaskulyong4, A. Dechaphunkul5, K.H. Lee6, F. Imamura7, N. Nogami8, Y. Cheng9, B.C. Cho10, E.K. Cho11, J. Vansteenkiste12, P.J. Voon13, C. Zhou14, J. Gray15, R. Hodge16, Y. Rukazenkov16, J. Soria17

Author affiliations

  • 1 Department Of Thoracic Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Winship Cancer Institute, Emory University, Atlanta/US
  • 3 Faculty Of Medicine, Ramathibodi Hospital, Mahidol University, 10400 - Bangkok/TH
  • 4 Oncology Unit, Department Of Medicine, Chiang Mai University, Chiang Mai/TH
  • 5 Division Of Medical Oncology, Department Of Internal Medicine, Prince of Songkla University, Songkhla/TH
  • 6 Division Of Medical Oncology, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheong-ju/KR
  • 7 Department Of Thoracic Oncology, Osaka International Cancer Institute, 541-8567 - Osaka/JP
  • 8 Department Of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 9 Division Of Thoracic Oncology, Jilin Provincial Cancer Hospital, Changchun/CN
  • 10 Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul/KR
  • 11 Division Of Hematology And Oncology, Department Of Internal Medicine, Gachon University Gil Medical Center, Incheon/KR
  • 12 Respiratory Oncology Unit (pulmonology), University Hospital KU Leuven, 3000 - Leuven/BE
  • 13 Department Of Thoracic Oncology, Hospital Umum Sarawak, Kuching/MY
  • 14 Department Of Oncology, Pulmonary Hospital of Tongji University, Shanghai/CN
  • 15 Department Of Thoracic Oncology, H. Lee Moffitt Cancer Center & Research Institute, 33612 - Tampa/US
  • 16 Biostatistics And Informatics, AstraZeneca, Cambridge/GB
  • 17 Ditep, Institut Gustave Roussy, 94800 - Villejuif/FR


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Abstract 2131


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%. 

PFS benefit was consistent across all subgroups, including pts with/without CNS mets at study entry. Median total treatment duration (range): 16.2 (0.1–27.4) months with osimertinib; 11.5 (0–26.2) with SoC. All causality adverse events (AEs), by investigator: osimertinib, 98% (Gr ≥ 3, 34%); SoC, 98% (Gr ≥ 3, 45%). AEs leading to discontinuation: osimertinib, 13%; SoC, 18%. Most common all causality AEs with osimertinib: diarrhoea (58% [Gr ≥ 3, 2%]), dry skin (32% [


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

AstraZeneca LLP


AstraZeneca LLP


Y. Ohe: Honoraria: AstraZeneca, Chugai, Lilly, ONO, BMS, Daiichi-Sankyo, Nipponkayaku, Boehringer Ingelheim, Bayer, Pfizer, MSD, Taiho. Research Funding : AstraZeneca, Chugai, Lilly, ONO, BMS, Kyorin, Dainippon- Sumitomo, Pfizer, Taiho, Novartis, Merck Serono, Consulting or Advisory Role: AstraZeneca, Chugai, Lilly, ONO, Novartis. S. Ramalingam: Advisory Board Meeting for: AstraZeneca, Bristol-Myers Squibb, Genentech, Boehringer Ingelheim. F. Imamura: Research funding and honoraria from AstraZeneca. N. Nogami: Research funding: AstraZeneca. J. Vansteenkiste: Research funding: AstraZeneca; honoraria/consulting: 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: Employee of AstraZeneca and own AstraZeneca shares. Y. Rukazenkov: Full time employee of AstraZeneca and hold shares in AstraZeneca. J.-C. Soria: Consultancy fees for AstraZeneca, Roche. All other authors have declared no conflicts of interest.

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