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EP4 Antagonist ONO-4578 Plus Nivolumab and Chemotherapy in HER2-Negative Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer - PubMed

4 hours ago
  • #Gastric Cancer
  • #Immunotherapy
  • #Phase 2 Trial
  • EP4 antagonist ONO-4578 combined with nivolumab and chemotherapy improved progression-free survival in HER2-negative unresectable advanced or recurrent gastric/gastroesophageal junction cancer.
  • The study showed a hazard ratio of 0.67 for PFS and 0.60 for OS, with an objective response rate of 62.0% in the ONO-4578 group versus 48.7% in the placebo group.
  • Greater benefit was observed in patients with PD-L1 CPS ≥1, while no clear benefit was seen in those with CPS <1 or indeterminate status.
  • Common adverse events included diarrhoea (55.7%) and anaemia (55.0%) in the ONO-4578 group, with manageable safety overall.
  • The findings support further investigation in a phase 3 trial for this first-line treatment regimen.