Atezolizumab Plus Bevacizumab Shows Superior Outcomes Compared to TACE in Intermediate-Stage Hepatocellular Carcinoma
Key Insights
Interim analysis from the phase 3b IKF-035/ABC-HCC (search) trial demonstrates that atezolizumab plus bevacizumab achieved a median time to treatment failure of 14.59 months compared to 9.46 months with TACE in intermediate-stage hepatocellular carcinoma (search) patients.
The combination therapy showed a statistically significant 45.5% reduction in risk of treatment failure compared to transarterial chemoembolization (search) (HR, 0.545; P = .0043).
Safety profile was manageable with slightly more adverse events in the immunotherapy combination arm, including higher rates of hypertension, diarrhea, and anorexia compared to TACE.
Systemic therapy with atezolizumab plus bevacizumab demonstrated superior outcomes compared with transarterial chemoembolization (search) (TACE) among patients with intermediate-stage hepatocellular carcinoma (search) (HCC (search)), according to interim analysis findings from the phase 3b IKF-035/ABC-HCC trial presented at the 2026 ASCO Gastrointestinal Cancers Symposium.
The combination immunotherapy achieved a median time to failure of treatment strategy (TTFS) of 14.59 months (95% CI, 11.07-17.97) among 87 patients compared with 9.46 months (95% CI, 6.97-11.27) among 81 patients who received TACE (HR, 0.545; 95% CI, 0.359-0.826; P = .0043).
Trial Design and Patient Population
The international, multicenter, open-label phase 3b trial is evaluating the safety and efficacy of atezolizumab/bevacizumab versus TACE among patients with intermediate-stage HCC (search). The study plans to randomly assign 320 patients 1:1 to receive either atezolizumab at 1200 mg intravenously plus bevacizumab at 15 mg/kg every 3 weeks or TACE.
Investigators are conducting the study at approximately 70 sites across Germany, Spain, France, Italy, Austria, Japan, and India. As of December 2025, 231 patients have enrolled in the study.
Eligible patients have intermediate-stage HCC (search) that is not amenable to curative surgery, liver transplantation, or curative ablation but is amenable to TACE. Additional eligibility criteria include a Child-Pugh-Score of A or B7, no extrahepatic disease, no massive multinodular pattern preventing adequate TACE, an ECOG performance status of 0 or 1, and no other severe comorbidities.
Treatment Delivery and Patient Characteristics
In the atezolizumab/bevacizumab arm, 97.7% of patients completed at least one dose, with a median of 12 dosing cycles (range, 1-32). In the TACE arm, 93.8% of patients received at least one dose, with a median of 2 TACE cycles (range, 1-8).
At the time of analysis, the median age was 73 years in both arms (range, 51-89 for atezolizumab arm; 45-88 for TACE arm), with most patients being male (86.2% vs 84.0%). Most patients in each respective arm had an ECOG performance status of 0 (81.6% vs 93.8%), a BCLC status of B (59.8% vs 77.8%), and no minimal vascular invasion (90.8% vs 96.3%).
Safety Profile
All patients (100%) experienced at least one adverse event across both arms, with 55.2% from the atezolizumab/bevacizumab arm and 40.7% from the TACE arm having grade 3 or higher toxicities. Any-grade serious adverse events were reported in 44.8% and 35.8% of patients in each respective arm; 18.4% and 13.6% had grade 3 or higher serious adverse events.
Fatal serious adverse events occurred in 6.9% and 5.2% of patients, which included one patient in the atezolizumab/bevacizumab arm (1.1%) who had an event related to study treatment.
The most common adverse events in the atezolizumab/bevacizumab versus TACE arms included hypertension (26.4% vs 9.9%), diarrhea (24.1% vs 8.6%), anorexia (16.1% vs 6.2%), weight loss (14.9% vs 6.2%) and pruritus (12.6% vs 4.9%).
Study Endpoints and Future Analysis
The trial's primary endpoint is TTFS. For patients receiving atezolizumab/bevacizumab, this encompasses radiologic progression plus any of the following: loss of clinical benefit, unacceptable toxicity, liver function deterioration, or therapy becoming inapplicable for other reasons. In the TACE arm, patients who experience radiologic progression or stable disease fulfill the criteria for TTFS.
Secondary endpoints include overall survival, objective response rate, time to progression, time to loss of systemic treatment, progression-free survival, duration of response, and safety. Investigators will also evaluate baseline PD-L1 (search) protein expression in FFPE tumor tissue as an exploratory endpoint.
"This is a first interim analysis of the comparison of systemic therapy with [atezolizumab/bevacizumab] vs TACE in patients with intermediate-stage disease. We see nothing unexpected with respect to safety, but [there were slightly] more safety events in arm A," stated presenting study author Peter Galle, MD, PhD, Chairman of the First Department of Internal Medicine at University Medical Center in Mainz, Germany. "Based on these positive data, this trial continues."
The second interim analysis at 66% information times is expected to occur in the third quarter of 2026. With a data cutoff of June 13, 2025, investigators noted that data from the interim analysis were still premature and based on specific site reporting, with data cleaning underway and potential for slight changes at the time of final analysis.