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Poster Discussion session -Gastrointestinal, non-colorectal

1905 - A phase 3 study of nivolumab (Nivo) in previously treated advanced gastric or gastric esophageal junction (G/GEJ) cancer (ATTRACTION-2): Two-years update data.

Date

19 Oct 2018

Session

Poster Discussion session -Gastrointestinal, non-colorectal

Topics

Immunotherapy

Tumour Site

Gastric Cancer

Presenters

Taroh Satoh

Citation

Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282

Authors

T. Satoh1, L. Chen2, Y. Kang3, Y. Chao4, K. Kato5, H.C. Chung6, J. Chen7, K. Muro8, W.K. Kang9, T. Yoshikawa10, S.C. Oh11, T. Tamura12, K. Lee13, N. Boku14

Author affiliations

  • 1 Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, 565-0871 - Suita/JP
  • 2 Internal Medicine, National Cheng-Kung University Hospital, 704 - Tainan/TW
  • 3 Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 4 Department Of Oncology, Taipei Veterans General Hospital, Taipei/TW
  • 5 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 6 Oncology, Yonsei University College of Medicine, Seoul/KR
  • 7 School Of Medicine, Chung Gung University, 333 - Tao Yuan/TW
  • 8 Department Of Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 9 Hematology-oncology, Samsung Medical Center Sungkyunkwan University School of Medicine, 06351 - Seoul/KR
  • 10 Gastrointestinal Surgery, Kanagawa Cancer Center, 2410815 - Yokohama/JP
  • 11 Division Of Hematology/oncology, Internal Medicine Department, Korea University Guro Hospital, College of Medicine, Korea University, Seoul/KR
  • 12 Department Of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama/JP
  • 13 Department Of Internal Medicine, Seoul National University Bundang Hospital, Seoul/KR
  • 14 Gastrointestinal Medical Oncology, National Cancer Center Hospital, 1040045 - Tokyo/JP
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Resources

Abstract 1905

Background

Nivo monotherapy has shown superior efficacy with manageable safety for G/GEJ cancer refractory to, or intolerant of standard chemotherapy in a phase 3 study (ATTRACTION-2). Here, we report 2-year updated results of survival.

Methods

A total of 493 patients with 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) until progressive disease or unacceptable toxicity. The primary endpoint was overall survival (OS). Updated results of the efficacy and safety were based on ≥ 2-year follow-up after last patient enrollment. As a subgroup analysis, the OS data by BOR was evaluated.

Results

As of data cut-off on February 2018, 2 years after last patient enrollment, the median OS (mOS) was 5.3 months with Nivo versus 4.1 months with placebo (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.51-0.76). The OS rates of Nivo and Placebo were 27.3% and 11.6% at 12 months, and 10.6% and 3.2% at 24 months, respectively. In a OS subgroup analysis stratified by BOR, mOS in PR patients in Nivo arm was not reached. Median OS in SD patients were 9.4 and 7.6 months (HR 0.70, 95%CI 0.44-1.09), and mOS in PD patients were 3.8 and 3.8 months (HR 0.86, 5%CI 0.64-1.16) in Nivo and placebo arm, respectively. In addition, 12-month OS rate in PR patients was 86.7% in Nivo arm. OS rate at 12 months in SD patients were 36.9 and 24.2%, and OS rate at 12 months in PD patients were 12.4 and 6.9% in Nivo and placebo arm, respectively. The safety analysis for 2-year follow-up will be presented.

Conclusions

Nivo has significantly improved OS with 2-year follow-up. In PR and SD patients, the subgroup analysis of OS favored Nivo over placebo.

Clinical trial identification

NCT02267343. Other Study ID Numbers: ONO-4538-12.

Legal entity responsible for the study

Ono Pharmaceutical Co., Ltd.

Funding

Ono Pharmaceutical Co., Ltd and Bristol-Myers Squibb.

Editorial Acknowledgement

We thank Naokazu Gion for providing statistical support, the project leader Mitsunobu Tanimoto (ONO Pharmaceutical,.CO.LTD.).

Disclosure

T. Satoh: Consulting fees: Chugai, Ono, Taiho, Eli Lilly, Daiichi Sankyo; Honoraria: Chugai, Ono, Yakult Honsha, Bristol-Myers Squibb, Merck Serono, Taiho, Eli Lilly, Daiichi Sankyo; Departmental research grants: Chugai, Ono, Yakult Honsha. L-T. Chen: Advisory board role: Ono, BMS, MSD, Eli Lilly, PhamaEngine, Five Prime, Novartis, AstraZeneca; Honoraria: Ono, BMS, MSD, Eli Lilly, PhamaEngine, TTY, SyncoreBio, Five Prime, Novartis, AstraZeneca, Ipsen; Research funds: Novartis, Pfizer, Merck Serono, Polaris, TTY, SyncoreBio, Celgene. Y-K. Kang: Personal fees: Ono Pharmaceutical. Co., Ltd., Bristol-Myers Squibb, Lilly / ImClone, Taiho Pharmaceutical, Novartis, Roche / Genentech, Bayer; Grants: Roche / Genentech, Novartis, Bayer. K. Kato: Research funds: Ono Pharmaceutics, Merck and Co. Shionogi, Merck Serono. H.C. Chung: Consultation honoraria: Taiho, Celltrion, MSD, Lilly, Quintiles, BMS, Merck-Serono; Research funds: Lilly, GSK, MSD, Merck-Serono, BMS-Ono, Taiho; Speaker\'s bureau: Merck-Serono, Lilly, Foundation-Medicine. J-S. Chen: Research funds: Ono/BMS, MSD, Ill Lilly, Roche; Speaker\'s bureau: Ono/BMS, MSD, Ill Lilly, TTY Biopharm, Novartis. K. Muro: Honoraria: Ono, Chugai, Bayer, Takeda, Taiho and Eli Lilly; Research funds: MSD, Ono, Daiichi Sankyo, Shionogi, Kyowa Hakko Kirin, Gilead Science. T. Yoshikawa: Honoraria: Ono, Bristol, Lilly, Chugai, Taiho, Yakult, MSD, Abbott, Takeda, Daiichi-Sankyo, Nihon-Kayaku, Kaken-Seiyaku, Olympus, Johnson and Johnson, and Covidien; Research funds: Chugai, Taiho, Yakult, Novartis. T. Tamura: Research funds: Ono, Bristol-Myers Squibb. K-W. Lee: Research funds: Ono Pharmaceutical (to institution). N. Boku: Honoraria: Ono, Bristol-Myers Squibb; Research funds: Ono, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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