Phase 3 study of adjuvant atezolizumab plus bevacizumab for hepatocellular carcinoma with high risk of recurrence after resection or ablation

The risk of hepatocellular carcinoma (HCC) recurrence is 70%-80% at five years after resection or ablation, indicating an unmet need for effective adjuvant therapies. The combination of atezolizumab and bevacizumab (atezo-bev) is standard of care for unresectable HCC. The multinational phase 3 IMbrave050 study evaluated atezo-bev versus active surveillance (AS) after resection or ablation of high-risk HCC (high-risk defined based on tumor size and number, vascular invasion, and tumor differentiation). At an interim analysis after median follow-up of 17.4 months, the independent review facility assessed recurrence-free survival was significantly longer with atezo-bev compared with AS (HR 0.72; p=0.0120). Results were generally consistent across clinical subgroups. The safety of atezo-bev was generally manageable and consistent with the known safety profile of both agents. The authors conclude that atezo-bev is the first adjuvant regime to demonstrate a significant and clinically meaningful improvement in RFS versus AS in patients at high risk of recurrence following resection or ablation.