Long-term outcomes of atezolizumab-bevacizumab in unresectable hepatocellular carcinoma: A real-world study.

BACKGROUND AND AIMS: Unlike other immune-based combinations for hepatocellular carcinoma (HCC), long-term data for atezolizumab-bevacizumab (AB) are lacking, as the IMbrave150 trial closed after a median follow-up of 15.6 months. Consequently, reports of long-term outcomes for AB rely mainly on real-world evidence. We evaluated long-term effectiveness, safety, and clinically relevant on-treatment events in a large prospective real-world cohort of patients treated with AB.

APPROACH AND

RESULTS

We analyzed 538 patients prospectively enrolled in the Italian ARTE database. Outcomes included overall survival (OS), safety, liver decompensation, rate of patients achieving drug-free disease-free status. On-treatment events were modelled as time-dependent covariates in Cox regression models. After a median follow-up of 24.2 months, median OS was 19.7 months (95% CI 17.2-22.2), with a 36-month survival rate of 30.0%. Independent factors influencing OS included ECOG-PS >0, ALBI grade >1, AFP >400 ng/mL, multinodularity, macrovascular invasion, and on-treatment events (objective response, progression, or liver decompensation). Grade ≥3 AEs occurred in 36.8% of patients; 5 late-onset severe toxicities arose beyond 24 months. Liver decompensation unrelated to tumor progression occurred in 14.1% patients. Eighty patients (14.9%) underwent surgical or locoregional procedures after the initiation of AB; 24 (4.4%) achieved a drug-free disease-free status.

CONCLUSIONS

Our data confirmed the sustained effectiveness of AB without new safety concerns. Surgical/locoregional treatments after the start of AB and liver decompensation were common, highlighting the need for a multidisciplinary and integrated approach in advanced HCC.