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Gastrointestinal tumours, non-colorectal 1

4410 - A Phase 3 Study of Nivolumab (Nivo) in Previously Treated Advanced Gastric or Gastroesophageal Junction (G/GEJ) Cancer: Updated Results and Subset Analysis by PD-L1 Expression (ATTRACTION-02)


08 Sep 2017


Gastrointestinal tumours, non-colorectal 1


Immunotherapy;  Oesophageal Cancer;  Gastric Cancer;  Prostate Cancer


Narikazu Boku


Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369


N. Boku1, Y. Kang2, T. Satoh3, Y. Chao4, K. Kato5, H.C. Chung6, J. Chen7, K. Muro8, W.K. Kang9, T. Yoshikawa10, S.C. Oh11, T. Tamura12, K. Lee13, L. Chen14

Author affiliations

  • 1 Division Of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 2 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 3 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
  • 4 Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 5 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 6 Department Of Internal Medicine, Yonsei Cancer Center, Song Dang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, 120-752 - Seoul/KR
  • 7 Department Of Internal Medicine, Chang Gung Memorial Hospital-Linkou, 333 - Taoyuan/TW
  • 8 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 9 Oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 10 Department Of Gastrointestinal Surgery, Kanagawa Cancer Center, 2418515 - Yokohama/JP
  • 11 Division Of Hematology/oncology, Internal Medicine Department, College of Medicine, Korea University, Seoul, Korea, Seoul/KR
  • 12 Medical Oncology, Kindai University Faculty of Medicine, Osaka/JP
  • 13 Medical Oncology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam/KR
  • 14 National Institute Of Cancer Research, National Health Research Institutes, and National Cheng Kung University Hospital,, 704 - Tainan/TW


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Abstract 4410


Nivo monotherapy demonstrated its efficacy with manageable safety for G/GEJ cancer refractory or intolerant to standard chemotherapy at the primary analysis (ATTRACTION-02[ONO-4538-12]: ASCO-GI 2017, Kang YK et al. J Clin Oncol. 2017; 35 [suppl 4S abstract 2]). Here, we report updated results, and the relationship between efficacy of Nivo and PD-L1 expression levels.


493 patients(pts) aged ≥ 20 years with ECOG PS 0-1 and unresectable advanced or recurrent G/GEJ cancer after failure of two or more previous chemotherapy regimens were randomized in a 2:1 ratio to receive 3 mg/kg Nivo (N = 330) or placebo (N = 163) every 2 weeks until unacceptable toxicity or disease progression. The primary endpoint was overall survival (OS). The PD-L1 expression was assessed by immunohistochemistry (28-8 pharmDx assay). And updated results of the efficacy and safety were based on ≥ 1-year follow-up after last patient enrollment.


As of the data cut-off on February 25th 2017, one year after last patient enrollment, the median OS (mOS) was 5.32 months with Nivo versus 4.14 months with placebo (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.50-0.75; p 


With minimum 1-year of follow-up, long-term survival benefit of nivolumab was confirmed for patients with advanced G/GEJ cancer. Although tumor samples were available only in 40% of all enrolled patients, Nivo demonstrated benefit irrespective of PD-L1 expression in the exploratory analysis.

Clinical trial identification


Legal entity responsible for the study

Ono Pharmaceutical Co., Ltd


Ono Pharmaceutical Co., Ltd, Bristol-Myers Squibb


N. Boku: Ono, Taiho, Chugai, Eli-Lilly. Y-K. Kang: Ono, Bristol-Myers Squibb, Lilly/ImClone, Taiho Pharmaceutical, Roche/Genentech, Novartis, Bayer. T. Satoh: Ono. K. Kato: Ono, Shionogi, MSD. H.C. Chung: Lilly, GSK, MSD, Merck Serono, BMS, Ono, Taiho, Celltrion, Quintiles, BMS. K. Muro: Shionogi, MSD K.K., Daiichi Sankyo, Kyowa Hakko Kirin, Gilead Sciences, Chugai, Takeda, Eli Lilly Japan K.K., Merck Serono, Taiho, Yakult Honsha. T. Yoshikawa: Taiho, Chugai, Yakult, Ono, MSD. K-W. Lee: Ono. L-T. Chen: Ono, Eli-Lilly, MSD, PharmaEngine, Merrimack, TTY, Syncore, Five Prime, Novartis, GSK, Merck Serono, Polaris, Anti-Alpha Enolase (ENO-1) monoclonal antibody/HuniLife. All other authors have declared no conflicts of interest.

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