The research article by Dr. Shitara et al. was published in the journal Nature on March 24, 2022

March 24, 2022
日本語

The research article by Dr. Shitara et al. was published in the journal Nature on March 24 2022, Japan time.

Author：Kohei Shitara

Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Japan

「The combination of nivolumab plus chemotherapy for gastric cancer has already been approved and recommended as first-line treatment in Japan. Current research reconfirms its efficacy after long-term follow-up and suggests the importance of biomarkers such as PD-L1 CPS and MSI. Although nivolumab plus ipilimumab did not show a significant survival benefit, I think that these results are important for future studies. I am honored to report the results of a clinical trial that has changed the standard of care in gastric cancer in the Nature.」

Publication

• Journal name: Nature
• Title: Nivolumab plus chemotherapy or ipilimumab in gastroesophageal cancer
• Authors: Kohei Shitara, Jaffer A. Ajani, Markus Moehler, Marcelo Garrido, Carlos Gallardo, Lin Shen, Kensei Yamaguchi, Lucjan Wyrwicz, Tomasz Skoczylas, Arinilda Campos Bragagnoli, Tianshu Liu, Mustapha Tehfe, Elena Elimova, Ricardo Bruges, Thomas Zander, Sergio de Azevedo, Ruben Kowalyszyn, Roberto Pazo-Cid, Michael Schenker, James M. Cleary, Patricio Yanez, Kynan Feeney, Michalis V Karamouzis, Valerie Poulart, Ming Lei, Hong Xiao, Kaoru Kondo, Mingshun Li, and Yelena Y. Janjigian
• DOI: 10.1038/s41586-022-04508-4
• URL: https://www.nature.com/articles/s41586-022-04508-4
• Publication date: March 24,2022(Japan time) 

Highlights

• National Cancer Center Hospital East joined a sponsor-initiated clinical trial (CheckMate 649) to evaluate the efficacy and safety of the combination of first-line chemotherapy plus nivolumab, an anti-PD-1 antibody therapy, or nivolumab plus anti-CTLA4 inhibitor ipilimumab versus chemotherapy alone for patients with advanced gastric/gastroesophageal junction/esophageal adenocarcinoma.
• We report both long-term follow-up results from nivolumab-plus-chemotherapy versus chemotherapy and first results from nivolumab-plus-ipilimumab versus chemotherapy
• After 24.0-month minimum follow-up, nivolumab-plus-chemotherapy versus chemotherapy continued to demonstrate improvement in OS in PD-L1 CPS ≥5 (hazard ratio (HR) 0.70) and all-randomized patients (0.79)
• OS in patients with PD-L1 CPS ≥5 for nivolumab-plus-ipilimumab versus chemotherapy did not meet the prespecified boundary for significance.
• No new safety signals were identified with nivolumab-plus-chemotherapy.
• The results support the continued use of nivolumab-plus-chemotherapy as standard first-line treatment for advanced gastroesophageal adenocarcinoma.

Support

• CheckMate 649 (NCT02872116) is a randomized, open-label, multicenter, global phase 3 trial conducted at 175 hospitals and cancer centers in 29 countries across Asia, Australia, Europe, North America, and South America.
• This study was supported by Bristol Myers Squibb and Ono Pharmaceutical Co., Ltd.