Nivolumab plus chemotherapy or ipilimumab in gastro-oesophageal cancer

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 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 ()
Additional contact information
Kohei Shitara: National Cancer Center Hospital East
Jaffer A. Ajani: The University of Texas MD Anderson Cancer Center
Markus Moehler: Johannes-Gutenberg University Clinic
Marcelo Garrido: Pontificia Universidad Católica
Carlos Gallardo: Fundación Arturo López Pérez
Lin Shen: Peking University Cancer Hospital and Institute
Kensei Yamaguchi: The Cancer Institute Hospital of JFCR
Lucjan Wyrwicz: Narodowy Instytut Onkologii
Tomasz Skoczylas: Medical University of Lublin
Arinilda Campos Bragagnoli: Fundacao Pio Xii Hospital Cancer De Barretos
Tianshu Liu: Zhongshan Hospital Fudan University
Mustapha Tehfe: Oncology Center – Centre Hospitalier de l’Universite de Montreal
Elena Elimova: Princess Margaret Cancer Centre
Ricardo Bruges: Instituto Nacional de Cancerologia E.S.E.
Thomas Zander: University of Cologne, Department of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Düesseldorf; Gastrointestinal Cancer Group Cologne (GCGC)
Sergio Azevedo: Hospital de Clínicas de Porto Alegre
Ruben Kowalyszyn: Clinica Viedma S.A.
Roberto Pazo-Cid: Hospital Universitario Miguel Servet
Michael Schenker: SF Nectarie Oncology Center
James M. Cleary: Dana Farber Cancer Institute
Patricio Yanez: Universidad de La Frontera, James Lind Cancer Research Center
Kynan Feeney: St John of God Murdoch Hospital
Michalis V. Karamouzis: Laiko General Hospital of Athens
Valerie Poulart: Bristol Myers Squibb
Ming Lei: Bristol Myers Squibb
Hong Xiao: Bristol Myers Squibb
Kaoru Kondo: Bristol Myers Squibb
Mingshun Li: Bristol Myers Squibb
Yelena Y. Janjigian: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College

Nature, 2022, vol. 603, issue 7903, 942-948

Abstract: Abstract Standard first-line chemotherapy results in disease progression and death within one year in most patients with human epidermal growth factor receptor 2 (HER2)-negative gastro-oesophageal adenocarcinoma1–4. Nivolumab plus chemotherapy demonstrated superior overall survival versus chemotherapy at 12-month follow-up in gastric, gastro-oesophageal junction or oesophageal adenocarcinoma in the randomized, global CheckMate 649 phase 3 trial5 (programmed death ligand-1 (PD-L1) combined positive score ≥5 and all randomized patients). On the basis of these results, nivolumab plus chemotherapy is now approved as a first-line treatment for these patients in many countries6. Nivolumab and the cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitor ipilimumab have distinct but complementary mechanisms of action that contribute to the restoration of anti-tumour T-cell function and induction of de novo anti-tumour T-cell responses, respectively7–11. Treatment combining 1 mg kg−1 nivolumab with 3 mg kg−1 ipilimumab demonstrated clinically meaningful anti-tumour activity with a manageable safety profile in heavily pre-treated patients with advanced gastro-oesophageal cancer12. Here we report both long-term follow-up results comparing nivolumab plus chemotherapy versus chemotherapy alone and the first results comparing nivolumab plus ipilimumab versus chemotherapy alone from CheckMate 649. After the 24.0-month minimum follow-up, nivolumab plus chemotherapy continued to demonstrate improvement in overall survival versus chemotherapy alone in patients with PD-L1 combined positive score ≥5 (hazard ratio 0.70; 95% confidence interval 0.61, 0.81) and all randomized patients (hazard ratio 0.79; 95% confidence interval 0.71, 0.88). Overall survival in patients with PD-L1 combined positive score ≥ 5 for nivolumab plus ipilimumab versus chemotherapy alone did not meet the prespecified boundary for significance. No new safety signals were identified. Our results support the continued use of nivolumab plus chemotherapy as standard first-line treatment for advanced gastro-oesophageal adenocarcinoma.

Date: 2022
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DOI: 10.1038/s41586-022-04508-4

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