Innovent Biologics announced first patient dosing in a phase 2/3 trial of Tyvyt with IBI305 for patients with advanced hepatocellular carcinoma taking place in China, according to a press release.
"HCC is the fourth most common cancer and the second leading cause of cancer related death in China,” Fan Jia, president of Zhongshan Hospital, said in the release. “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.”
Tyvyt (sintilimab injection) is a fully human anti-programmed cell death protein 1 monocloncal antibody. IBI305 is recombinant humanized anti-vascular endothelial growth factor monoclonal antibody.
The randomized control ORIENT-32 study will include 566 patients with advanced HCC. Results from the trial will be compared with Nexavar (sorafenib, Bayer) for safety and efficacy.
“The development of new agents for the treatment of advanced HCC has been stagnant, so there is a huge unmet clinical need,” Michael Yu, founder, CEO and chairman of Innovent, said in the release. “Based on the encouraging data we have observed in our phase Ib study, we have decided to conduct the ORIENT-32 trial. We seek to discover, develop, and commercialize products that provide more effective cancer treatment to help our patients and their families.”