Efficacy and Safety of Nivolumab Plus Chemotherapy in Untreated Gastric Cancer: Real-world Study

Strategic Insights -

A recent observational study conducted in Japan has evaluated the effectiveness and safety of nivolumab plus chemotherapy in untreated patients with advanced or recurrent gastric cancer. The study found that the objective response rate (ORR) was 65.6% and the median real-world progression-free survival (rwPFS) was 6.9 months. The study's results support the use of nivolumab plus chemotherapy in this patient population.

Key Takeaways:

  • The study enrolled 527 patients with a median age of 70.3 years and 65.5% male.
  • The median follow-up period was 10.4 months, with 91.3% of patients experiencing treatment-related adverse events (TRAEs) and 40.4% experiencing grade 3 or higher TRAEs.
  • The objective response rate (ORR) was 65.6% (95% CI, 59.9-70.9%), with significant improvement in subgroups stratified by age (age ≥ 75 years) and PD-L1 combined positive score (CPS) = 5.
  • The median real-world progression-free survival (rwPFS) was 6.9 months, with subgroup analysis showing a longer PFS in patients aged ≥ 75 years and those with PD-L1 CPS = 5.

Statistics:

  • 527 patients were enrolled in the study, with a median age of 70.3 years.
  • 91.3% of patients experienced treatment-related adverse events (TRAEs), with 40.4% experiencing grade 3 or higher TRAEs.
  • The objective response rate (ORR) was 65.6% (95% CI, 59.9-70.9%).
  • The median follow-up period was 10.4 months.
  • The median real-world progression-free survival (rwPFS) was 6.9 months, with subgroup analysis showing a longer PFS in patients aged ≥ 75 years and those with PD-L1 CPS = 5.

Sources:

  • An Observational Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced or Recurrent Gastric Cancer In Japanese Real-world Settings: the G-knight Study. Gastric Cancer, 2025.
  • "Findings on Gastric Cancer Detailed by Investigators at Aichi Cancer Center Hospital (An Observational Study of the Effectiveness and Safety of Nivolumab Plus Chemotherapy for Untreated Advanced or Recurrent Gastric Cancer In Japanese ...). Immunotherapy Weekly. August 13, 2025; p 1073."