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Poster display session

4540 - Interim safety and clinical activity of nivolumab (Nivo) in combination with S-1/capecitabine plus oxaliplatin in patients (pts) with previously untreated unresectable advanced or recurrent gastric/gastroesophageal junction (G/GEJ) cancer: part 1 study of ATTRACTION-04 (ONO-4538-37)

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Immunotherapy;  Oesophageal Cancer;  Gastric Cancer

Presenters

Yoon-Koo Kang

Citation

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

Authors

Y. Kang1, K. Kato2, H.C. Chung3, K. Minashi4, K. Lee5, H. Cho6, W.K. Kang7, Y. Komatsu8, M. Tsuda9, K. Yamaguchi10, H. Hara11, S. Fumita12, M. Azuma13, N. Boku14, L. Chen15

Author affiliations

  • 1 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 2 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 3 Division Of Medical Oncology, 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
  • 4 Clinical Trial Promotion Department, Chiba Cancer Center Hospital, 260-8717 - Chiba/JP
  • 5 Division Of Hematology/oncology, Department Of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam/KR
  • 6 Department Of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, (previous Kanagawa Cancer Center), 113-8677 - Tokyo/JP
  • 7 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 135-710 - Seoul/KR
  • 8 Department Of Cancer Chemotherapy, Hokkaido University Hospital Cancer Center, 060-8638 - Sapporo/JP
  • 9 Division Of Gastroenterology, Hyogo Cancer Center, 673-8558 - Akashi/JP
  • 10 Department Of Gastroenterological Chemotherapy, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 135-8550 - Tokyo/JP
  • 11 Gastroenterology, Saitama Cancer Center, Saitama/JP
  • 12 Department Of Medical Oncology, Research Associate, Nara hospital Kindai University faculty of medicine, Ikoma/JP
  • 13 Department Of Gastroenterology, Kitasato University School of Medicine, Kanagawa/JP
  • 14 Division Of Gastrointestinal Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 15 National Institute Of Cancer Research, National Health Research Institutes, and National Cheng Kung University Hospital,, 704 - Tainan/TW
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Resources

Abstract 4540

Background

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]). This randomized phase 2/3 trial is to evaluate the efficacy and safety of Nivo in combination with 1st line chemotherapy in unresectable advanced or recurrent G/GEJ cancer (NCT02746796).

Methods

This trial includes previously untreated pts aged ≥ 20 years with ECOG PS 0-1 and had measurable, unresectable advanced or recurrent HER2 (-) G/GEJ cancer. It consists of 2 parts. Part 1 is a randomized, open-label trial to evaluate the feasibility of Nivo (360 mg, Q3W) in combination with oxaliplatin (130 mg/m2, Q3W) plus either S-1 (40 mg/m2 twice daily, day 1-14, SOX) or capecitabine (1000 mg/m2 twice daily, day 1-14, CapeOX) in terms of activity and safety. Part 2 is a randomized, double-blind, placebo-controlled trial comparing Nivo to placebo in combination with SOX/CapeOX in terms of overall survival and progression free survival (PFS).

Results

A total of 40 pts were included into part 1, 21 pts were randomized to Nivo+SOX and 19 to Nivo+CapeOX. The median age was 62.5 years, 27 pts (67.5%) were male, 20 pts (50.0%) had ECOG PS 1. Median duration of treatment was 7.03 months (range 0.1-9.9) as of 24 Feb 2017. Both treatments were well tolerated. Grade 3-4 treatment-related adverse events (AEs) were reported 23 pts (57.5%). No Nivo-related AEs leading to discontinuation were reported. Overall response rate was 68.4% (26/38, CR10, PR16) and disease control rate was 86.8%. Median PFS was not reached. 18 pts (46.2%) remain on treatment at the time of the data cut off. There were no significant differences in activity and safety between the 2 treatments.

Conclusions

Nivo+SOX/CapeOX were feasible with promising activity as the 1st-line chemotherapy in pts with previously untreated unresectable advanced or recurrent G/GEJ cancer. Part 2 of the study is ongoing.

Clinical trial identification

NCT02746796

Legal entity responsible for the study

Ono Pharmaceutical Co., ltd.

Funding

Ono Pharmaceutical Co., ltd., Bristol-Myers Squibb

Disclosure

Y-K. Kang: Ono, Bristol-Myers Squibb, Lilly/ImClone, Taiho Pharmaceutical, Roche/Genentech, Novartis, Bayer. K. Kato: Ono Pharmaceutical Co., Ltd., Shionogi, MSD. H.C. Chung: Lilly, GSK, MSD, Merck-Serono, BMS/Ono, Taiho, Celltrion, Quintiles, BMS. K-W. Lee, K. Yamaguchi: Ono. Y. Komatsu: Taiho, Lilly, MSD, Ono, Novartis, Bayer, Chugai, Yakult, Pfizer, Merck. H. Hara: Chugai Pharma, Taiho Pharmaceutical, Merck Serono, Yakult Honsha, Lilly, AstraZeneca, MSD, Ono Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo. N. Boku: Ono, Taiho, Chugai, Eli-Lily. L-T. Chen: Novartis, GSK, Merck Serono, TTY, Polaris, ONO, Eli Lilly, MSD, PharmaEngine, Merrimack, Syncore, Five Prime, anti-alpha enolase (ENO-1) monoclonal antibody/HuniLife. All other authors have declared no conflicts of interest.

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