Randomized phase 2-3 study of sintilimab plus IBI305 versus sorafenib for unresectable HCC

The multicenter phase 2-3 study ORIENT-32 in China compared sintilimab (a PD-1 inhibitor) plus the bevacizumab biosimilar IBI305 versus sorafenib as first-line treatment for unresectable HBV-associated hepatocellular carcinoma. The median PFS was 4.6 months with sintilimab plus IBI305 versus 2.8 months with sorafenib (HR 0.56; p<0.0001). At the first interim analysis of overall survival, the median OS was not reached with sintilimab plus IBI305 versus 10.4 months with sorafenib (HR 0.57; p<0.0001). The safety profile of sintilimab plus IBI305 was acceptable.