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May 7, 2026Journal of Clinical Oncology2 citations

Perioperative Toripalimab Plus Chemotherapy Versus Chemotherapy Alone in Locally Advanced Gastric or Gastroesophageal Junction Cancer: 3-Year Follow-Up of NEOSUMMIT-01 Trial

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RNRun‐Cong NieYJYing JinCLCheng-Cai Liang

Key Points

  • To evaluate the long-term outcomes of adding toripalimab to chemotherapy in patients with advanced gastric cancer.
  • Randomised trial comparing toripalimab plus chemotherapy to chemotherapy alone
  • Total of 108 patients enrolled
  • Median follow-up of 43.2 months
  • 3-year event-free survival was 74.7% for toripalimab plus chemotherapy versus 56.2% for chemotherapy alone
  • 3-year overall survival was 81.3% for the toripalimab group compared to 72.2% for chemotherapy
  • Hazard ratio for event-free survival was 0.51; overall survival hazard ratio was 0.45

Abstract

The NEOSUMMIT-01 trial previously showed that adding the PD-1 antibody toripalimab to perioperative chemotherapy improved the pathologic response in patients with locally advanced gastric or gastroesophageal junction cancer. Here, we present the event-free survival (EFS) and overall survival (OS) after extended follow-up. A total of 108 patients were enrolled (toripalimab plus chemotherapy, n = 54; chemotherapy alone, n = 54). At the data cutoff date (August 29, 2025), the median follow-up was 43.2 months (interquartile range: 36.6-53.7). The 3-year EFS was 74.7% (95% CI, 63.6% to 87.7%) in the toripalimab plus chemotherapy group and 56.2% (95% CI, 43.3% to 73.0%) in the chemotherapy group, with a hazard ratio (HR) of 0.51 (95% CI, 0.27 to 0.98; P = .044). The 3-year OS was 81.3% (95% CI, 71.4% to 92.4%) versus 72.2% (95% CI, 61.2% to 85.2%), respectively, with an HR of 0.45 (95% CI, 0.21 to 0.95; P = .036). The survival benefits were consistent across most predefined subgroups and were maintained in the analysis excluding patients with dMMR. In conclusion, perioperative toripalimab plus chemotherapy significantly improved 3-year EFS and OS compared with chemotherapy alone, suggesting it as a promising treatment option for patients with locally advanced gastric or gastroesophageal junction cancer.

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Cite This Study

Nie et al. (2026) studied this question.

synapsesocial.com/papers/69fbe357164b5133a91a2850https://doi.org/10.1200/jco-25-02842
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