Updated data from IMbrave050: Adjuvant atezolizumab plus bevacizumab for high-risk hepatocellular carcinoma
- Study type
- Clinical trial
- Study name
- IMbrave050
- Design
- Randomised trial (1:1 ratio) comparing adjuvant treatment with active surveillance; updated post hoc analysis of recurrence-free survival and second interim analysis of overall survival
- Sample size
- Not stated in the abstract
- Source
- Journal of Hepatology · 2026
- Trial registration
- NCT04102098
In plain words
This study looked at whether giving two drugs, atezolizumab and bevacizumab, after surgery or ablation (burning away) of a liver tumour in patients at high risk of the cancer coming back would stop the cancer from returning. In the first analysis, the cancer seemed to come back less often in the group that received the drugs, but with longer follow-up this benefit did not last. The overall survival data are not yet complete, and the side effects of the drugs were manageable. For this reason, the authors concluded that this combination is not currently recommended as additional (adjuvant) treatment after surgery.
Key results
Treatment arms and regimens
Atezolizumab 1200 mg IV infusion + bevacizumab 15 mg/kg IV infusion on day 1 of each 21-day cycle, for 17 cycles (12 months) or until recurrence or unacceptable toxicity. Randomisation took place 4 to 12 weeks after resection or ablation.
This regimen is not approved as adjuvant therapy; in the updated analysis (J Hepatol 2026) the recurrence-free survival benefit was not sustained.
Active monitoring without drug treatment for 12 months; after recurrence confirmed by the independent review facility (IRF), crossover to atezolizumab + bevacizumab was allowed.
Source of the regimen details: Abstract of the paper (doses); this paper is a follow-up report and the regimen is that of the original IMbrave050 trial: ClinicalTrials.gov NCT04102098 (Interventions section) and the abstract of the original paper (Lancet 2023)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Adults with a first diagnosis of HCC who had undergone curative-intent surgical resection or ablation (radiofrequency or microwave only) 4 to 12 weeks before randomisation and were at high risk of recurrence (high-risk features defined in the full text); no major macrovascular invasion (except Vp1/Vp2) and no extrahepatic spread; Child-Pugh A and ECOG 0 or 1. Up to one cycle of adjuvant TACE after resection was allowed. Exclusion criteria (ClinicalTrials.gov): any HCC treatment before resection or ablation, clinically significant ascites, history of hepatic encephalopathy, bleeding from untreated or incompletely treated varices within the past 6 months, autoimmune disease, HBV and HCV (or HBV and HDV) co-infection, uncontrolled hypertension, and full-dose aspirin or anticoagulant use.
Endpoints
Primary endpoint at the primary interim analysis: recurrence-free survival (RFS) assessed by an independent review facility (IRF). Secondary endpoints included overall survival (OS) and safety. Stratification factors were geographical region and a composite factor (number of high-risk features, type of curative treatment and use of optional adjuvant transarterial chemoembolisation [one cycle] after resection).
Safety and side effects
The updated safety data were consistent with the primary analysis. The safety profile of atezolizumab + bevacizumab was reported as manageable and consistent with each drug and the underlying disease. Exact rates of grade ≥3 adverse events are not stated in the abstract.
Clinical significance and place in guidelines
Based on this updated analysis, the initial recurrence-free survival benefit was not durable, and the benefit–risk balance does not support atezolizumab + bevacizumab as adjuvant therapy in high-risk HCC after curative treatment. Subgroup analyses suggest possible benefit in some selected patients, which requires prospective evaluation. Effective adjuvant or perioperative therapy remains an unmet need. The status of this question in current guidelines should be checked separately.
Limitations
Based on the abstract: overall survival data remain immature and the updated RFS analysis was post hoc. Patients in the active surveillance group could cross over to atezolizumab + bevacizumab after recurrence, which may affect the interpretation of overall survival. The number of patients is not stated in the abstract. The suggestion of benefit in subgroups is exploratory and needs prospective evaluation.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.