Innovent Biologics has dosed the first patient in the ORIENT-15 Phase III clinical trial investigating tyvyt (sintilimab injection) in combination with chemotherapy (paclitaxel and cisplatin) as first-line treatment for the treatment of patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
The randomised, double-blind, multi-centre trial is designed to assess the efficacy and safety of the tyvyt and chemotherapy combination.
It aims to enrol and randomly distribute 640 patients in a 1:1 ratio into either experimental or control groups.
Primary objective of the ORIENT-15 trial is overall survival in all participants and in programmed cell death-1 ligand-1 (PD-L1) positive patients.
The China-based trial follows Phase Ib and II studies that examined tyvyt (sintilimab injection) in esophageal cancer patients and against paclitaxel / irinotecan as second-line therapy for treating advanced / metastatic ESCC respectively.
Innovent Biologics founder, CEO and chairman Michael Yu said: “Esophageal cancer is the third most common malignant tumour in China. The development of new agents for the treatment of advanced esophageal squamous cell carcinoma has been stagnant, so there is a huge unmet medical need.
“Based on the preliminary result or the ongoing Phase II study, we have decided to conduct ORIENT-15, a Phase III study as a first-line treatment for patients with esophageal squamous cell carcinoma.
“Our goal is to provide more effective cancer treatment options for these patients and for their families.”