Multicenter phase 2-3 study of donafenib versus sorafenib for unresectable or metastatic HCC

Donafenib is a modified form of sorafenib, with a trideuterated N-methyl group, potentially enhancing molecular stability. A multicenter phase 2-3 study in China compared donafenib versus sorafenib as first-line treatment for unresectable or metastatic hepatocellular carcinoma. The median overall survival was significantly longer with donafenib than with sorafenib (12.1 versus 10.3 months; HR 0.831; p=0.0245). There were no significant differences between both group in progression-free survival, objective response rate, and disease control rate. Drug-related grade 3 or higher adverse events occurred less frequently with donafenib than with sorafenib (38% versus 50%; p=0.0018).