Multicenter phase 3 study of second-line pembrolizumab versus placebo for aHCC in Asian patients

The phase 3 KEYNOTE-394 trial, in mainland China, Hong Kong, Malaysia, Taiwan, and South Korea, evaluated second-line pembrolizumab versus placebo in patients with advanced hepatocellular carcinoma after failure of sorafenib or oxaliplatin-based chemotherapy. Patients in the pembrolizumab group had longer OS and PFS and greater ORR compared with patients in the placebo group. Treatment-related adverse events occurred in 66.9% of the patients in the pembrolizumab group (1% grade 5) versus 49.7% of the patients in the placebo group (no grade 5).