Innovent Biologics has commenced dosing in the Phase II/III ORIENT-32 clinical trial of its Tyvyt (sintilimab injection) plus IBI305 combination as first-line therapy for advanced hepatocellular carcinoma (HCC), a common type of liver cancer.
Tyvyt is a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody.
IBI305 is a recombinant humanised monoclonal antibody and a biosimilar candidate of bevacizumab that targets vascular endothelial growth factor (VEGF).
The randomised, open-label, multi-centre ORIENT-32 trial is designed to assess the safety and efficacy of the combination therapy, compared to sorafenib, in 566 participants.
The primary endpoint of the trial is overall survival, while the primary outcome measures also include objective response rate.
Second outcome measures are disease control rate, duration of response, time to progression, progression-free survival and time to response.
Innovent Biologics founder, CEO and chairman Michael Yu said: “The development of new agents for the treatment of advanced HCC has been stagnant, so there is a huge unmet clinical need.
“Based on the encouraging data we have observed in our Phase Ib study, we have decided to conduct the ORIENT-32 trial, a Phase II/III study in first-line advanced HCC.”
Innovent is developing Tyvyt in China in alliance with Eli Lilly. Sintilimab injection is currently undergoing 20 clinical studies for a variety of solid tumours.
The therapeutic received marketing approval from the National Medical Products Administration (NMPA) in China for treating relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL).
Innovent announced acceptance of IBI305’s new drug application (NDA) last month.