Innovent's Sintilimab/Chemo Regime Shows Overall Survival Benefit In Gastric Cancer

  • Innovent Biologics Inc IVBIY has announced topline results from Phase 3 ORIENT-16 study evaluating sintilimab, meeting the primary endpoint of overall survival (OS).
  • The trial assessed sintilimab in combination with chemotherapy (oxaliplatin and capecitabine) compared to chemotherapy alone in the first-line treatment of patients with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • In an interim analysis, the sintilimab - chemotherapy regime demonstrated a statistically significant improvement in OS compared to placebo plus chemotherapy in both the intention-to-treat (ITT) and PD-L1 positive groups. 
  • No additional safety signals were identified. 
  • The results will be presented at an upcoming medical meeting.
  • Based on the study's Independent Data Monitoring Committee recommendation, Innovent plans to review these results and file a supplemental marketing application of sintilimab in China.
  • Sintilimab, marketed as Tyvyt (sintilimab injection) in China, is a PD-1 inhibitor jointly developed by Innovent and Eli Lilly And Co LLY.
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