Innovent Biologics, Inc. (Innovent), today announced that the first patient has been dosed in ORIENT-32, a trial that evaluates Tyvyt® (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody, in combination with IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, as first-line treatment for patients with advanced hepatocellular carcinoma (HCC).
The ORIENT-32 study is a randomized, open-label, multi-center, Phase II/III trial conducted in China to evaluate the safety and efficacy of Tyvyt® in combination with IBI305, compared to sorafenib as first-line treatment in patients with advanced HCC. 566 patients will be enrolled in the study. This study follows a Phase Ib study that evaluates Tyvyt® (sintilimab injection) in patients with advanced HCC.
“HCC is the fourth most common cancer and the second leading cause of cancer related death in China. The five-year survival rate is about 10%, and only 20-30% of patients have the opportunity for curative surgery. Current targeted therapies have only shown limited responses in HCC. Immune checkpoint inhibitors have brought new hope to patients with this life-threatening disease. We hope to validate the therapeutic potential of Tyvyt® in combination with IBI305 in the ORIENT-32 trial,” said Professor Fan Jia, President of Zhongshan Hospital, and an academician of the Chinese Academy of Sciences.
“China has a huge burden of HCC. Nearly 50% of HCC cases worldwide occur in China. 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. We seek to discover, develop, and commercialize products that provide more effective cancer treatment to help our patients and their families,” said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.