A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data

Li Tzong Chen, Taroh Satoh, Min Hee Ryu, Yee Chao, Ken Kato, Hyun Cheol Chung, Jen Shi Chen, Kei Muro, Won Ki Kang, Kun Huei Yeh, Takaki Yoshikawa, Sang Cheul Oh, Li Yuan Bai, Takao Tamura, Keun Wook Lee, Yasuo Hamamoto, Jong Gwang Kim, Keisho Chin, Do Youn Oh, Keiko MinashiJae Yong Cho, Masahiro Tsuda, Hiroki Sameshima, Yoon Koo Kang, Narikazu Boku

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4 Citations (Scopus)

Abstract

Background: Nivolumab showed improvement in overall survival (OS) in ATTRACTION-2, the first phase 3 study in patients with gastric/gastroesophageal junction (G/GEJ) cancer treated with ≥ 2 chemotherapy regimens. The 2-year follow-up results of ATTRACTION-2 are presented herein. Methods: ATTRACTION-2 was a randomized, double-blind, placebo-controlled, phase 3 trial (49 sites; Japan, South Korea, and Taiwan). The median (min–max) follow-up period was 27.3 (24.1–36.3) months. The primary endpoint was OS. A subanalysis of OS was performed based on best overall response and tumor-programmed death ligand-1 (PD-L1) expression status. Results: Overall, 493 of 601 screened patients were randomized (2:1) to receive nivolumab (330) or placebo (163). OS (median [95% confidence interval; CI]) was significantly longer in the nivolumab group (5.26 [4.60–6.37] vs 4.14 [3.42–4.86] months in placebo group) at the 2-year follow-up (hazard ratio [95% CI], 0.62 [0.51–0.76]; P < 0.0001). A higher OS rate was observed in the nivolumab vs placebo group at 1 (27.3% vs 11.6%) and 2 years (10.6% vs 3.2%). The OS benefit was observed regardless of tumor PD-L1 expression. Among patients with a complete or partial response (CR or PR) in the nivolumab group, the median OS (95% CI) was 26.6 (21.65—not applicable) months; the OS rates at 1 and 2 years were 87.1% and 61.3%, respectively. No new safety signals were identified. Conclusions: Nivolumab treatment resulted in clinically meaningful long-term improvements in OS in patients with previously treated G/GEJ cancer. The long-term survival benefit of nivolumab was most evident in patients with a CR or PR.

Original languageEnglish
Pages (from-to)510-519
Number of pages10
JournalGastric Cancer
Volume23
Issue number3
DOIs
Publication statusPublished - 2020 May 1

Keywords

  • Gastric cancer
  • Gastroesophageal junction cancer
  • Long-term
  • Nivolumab
  • Placebo

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

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    Chen, L. T., Satoh, T., Ryu, M. H., Chao, Y., Kato, K., Chung, H. C., Chen, J. S., Muro, K., Kang, W. K., Yeh, K. H., Yoshikawa, T., Oh, S. C., Bai, L. Y., Tamura, T., Lee, K. W., Hamamoto, Y., Kim, J. G., Chin, K., Oh, D. Y., ... Boku, N. (2020). A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data. Gastric Cancer, 23(3), 510-519. https://doi.org/10.1007/s10120-019-01034-7