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.