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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 Minashi  ;  Jae Yong Cho  ;  Masahiro Tsuda  ;  Hiroki Sameshima  ;  Yoon-Koo Kang  ;  Narikazu Boku 
 GASTRIC CANCER, Vol.23(3) : 510-519, 2020-05 
Journal Title
Issue Date
Gastric cancer ; Gastroesophageal junction cancer ; Long-term ; Nivolumab ; Placebo
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
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