Adjuvant atezolizumab plus bevacizumab falls short of improving RFS in high-risk HCC

An updated analysis of the IMbrave050 study reveals no sustained benefit on recurrence-free survival (RFS) among patients with high-risk hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab. Moreover, data on overall survival (OS) remains incomplete.

In this post hoc analysis, RFS did not reach statistical significance (hazard ratio [HR], 0.90, 95 percent confidence interval [CI], 0.72‒1.12) following treatment with atezolizumab plus bevacizumab. At the second interim analysis, OS data were still immature (HR, 1.26, 95 percent CI, 0.85‒1.87).

These findings persisted across clinically relevant subgroups, while updated safety data remained consistent with that of the primary analysis.

“The safety profile of atezolizumab plus bevacizumab remained manageable and consistent with that of each agent and the underlying disease,” the investigators said. “Overall, the benefit–risk profile does not support atezolizumab plus bevacizumab as adjuvant therapy.”

IMbrave 050 included HCC patients with high recurrence risk following resection or ablation. They were randomized to receive atezolizumab 1,200 mg plus bevacizumab 15 mg/kg intravenously every 3 weeks (17 cycles) or active surveillance for 1 year.

At the prespecified interim analysis, IMbrave050 met its primary endpoint of improved RFS in patients with high-risk HCC over a median follow-up of 17.4 months. The HR for the combination treatment was 0.72 (95 percent CI, 0.53‒0.98; p=0.012).

“The updated results of IMbrave050 do not support the use of atezolizumab plus bevacizumab in the adjuvant setting,” the investigators said. “However, subgroup analyses suggest a potential benefit in select patients, warranting further prospective evaluation.”