Multicenter phase 3 trial of first-line anlotinib plus penpulimab versus sorafenib for unresectable hepatocellular carcinoma

The phase 3 APOLLO trial, at 79 centers in China, compared the combination of anlotinib and penpulimab (anti-PD-1) versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma (uHCC). Median progression-free survival was 6.9 months versus 2.8 months (HR 0.52; p<0.0001) and median overall survival was 16.5 months versus 13.2 months (HR 0.69; p=0.0014). The most common grade ≥ 3 treatment-related adverse events were hypertension (17% with anlotinib-penpulimab and 10% with sorafenib) and decrease in platelet count (9% versus 6%); treatment-related deaths occurred in one versus two patients. The authors conclude that anlotinib plus penpulimab significantly improved PFS and OS versus sorafenib as first-line treatment for uHCC.