Promising Biomarker for Gastric Cancer Identified in Osaka, Japan

Strategic Insights -

Researchers from Osaka, Japan have identified a promising biomarker for gastric cancer, which could potentially aid in predicting the effectiveness of a specific immunotherapy treatment. The study, conducted by the Osaka International Cancer Institute, found that a tumor-infiltrating lymphocyte (TIL) biomarker was predictive of the efficacy of nivolumab monotherapy in patients with advanced non-small cell lung cancer (NSCLC) and gastric cancer.

Key Takeaways:

  • The study evaluated the potential of the TIL biomarker in predicting the effectiveness of nivolumab monotherapy in patients with advanced NSCLC and gastric cancer.
  • The research involved a phase II study (ONO-4538-88) that screened 37 patients with NSCLC and 127 patients with gastric cancer between March 2021 and January 2022.
  • The study found that 6 (16.2%) patients with NSCLC and 15 patients (11.8%) with gastric cancer met the TIL biomarker criteria.
  • The overall response rate (ORR) for NSCLC and gastric cancer was 80% (4/5 patients) and 36.4% (4/11 patients), respectively.
  • The median overall survival for NSCLC and gastric cancer was not reached and 25 months, respectively.
  • The median progression-free survival for NSCLC and gastric cancer was not reached and 5.59 months, respectively.
  • Treatment-related adverse events occurred in 13/19 patients overall: 5/6 patients for NSCLC and 8/13 patients for gastric cancer.
  • The study suggests that the TIL biomarker may have predictive utility for nivolumab monotherapy in patients with advanced NSCLC and gastric cancer.

Statistics:

  • 37 patients with NSCLC and 127 patients with gastric cancer were screened for the TIL biomarker.
  • 6 (16.2%) patients with NSCLC and 15 patients (11.8%) with gastric cancer met the TIL biomarker criteria.
  • The ORR for NSCLC was 80% (4/5 patients) and 36.4% (4/11 patients) for gastric cancer.
  • The median overall survival for NSCLC was not reached and 25 months for gastric cancer.
  • The median progression-free survival for NSCLC was not reached and 5.59 months for gastric cancer.

Sources:

  • Cancer Research Communications. Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1-Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter Study. 2025;5(10):1809-1820.
  • NewsRx. New Gastric Cancer Study Findings Reported from Osaka International Cancer Institute (Efficacy and Safety of Nivolumab Monotherapy in Patients with High PD-1-Positive CD8/Treg Ratio in Advanced NSCLC and Gastric Cancer: A Phase II, Multicenter ...). Immunotherapy Weekly. October 29, 2025; p 1227.