At the June 13, 2025, data cutoff, findings from the first interim analysis of the study demonstrated that patients who received the combination (n = 87) achieved a median time to TTFS event of 14.59 months (95% CI, 11.07-17.97) compared with 9.46 months (95% CI, 6.97-11.27) among patients who received TACE (n = 81). These data conferred an HR for TTFS of 0.545 (95 CI, 0.359-0.826; P = .0043), which was statistically significant.
“These first signals clearly suggest superiority of systemic therapy compared [with] TACE in regard to TTFS in intermediate-stage HCC,” Peter R. Galle, MD, PhD, the chairman of the First Department of Internal Medicine at University Medical Center in Mainz, Germany, said during the presentation.
How was IKF/ABC-HCC designed and what were the baseline characteristics?
IKF/ABC-HCC was an international, multicenter, open-label, investigator-initiated study that enrolled patients with intermediate-stage HCC who were not amenable to curative surgery, liver transplantation, or curative ablation but were amenable to TACE. Other key inclusion criteria included being at least 18 years old, having a Child-Pugh score class of A or B7 without ascites necessitating over 100 mg of spironolactone per day, an ECOG performance status of 0 or 1, a life expectancy of at least 3 months, adequate organ and bone marrow function, adequate laboratory values, and the absence of sever comorbidities.2 Patients with a minimal vascular invasion of Vp1 or Vp2 were permitted to enroll.
Eligible patients were randomly assigned 1:1 to receive intravenous (IV) atezolizumab at 1200 mg in combination with IV bevacizumab at 15 mg/kg every 3 weeks or TACE. Treatment in the investigational arm continued for 32 cycles or for a maximum of 24 months. Patients in the control arm received TACE as long as they were able. Treatment continued in both arms until loss of clinical benefit, unacceptable toxicity, or patient withdrawal.
The primary end point was TTFS. Secondary end points included overall survival (OS) 24-month OS rate, objective response rate, time to progression, time to loss of systemic treatment options, progression-free survival, duration of treatment, duration of response, time to deterioration of liver function, safety, and quality of life. Baseline PD-L1 expression in formalin-fixed, paraffin-embedded tumor tissue was assessed as an exploratory end point.
At baseline, the median age in the overall population (n = 168) was 73 years (range, 45-89). Most patients were male (85.1%), had an ECOG performance status of 0 (84.5%), had status B disease per Barcelona Clinic Liver Cancer criteria (74.4%), and did not have minimal vascular invasion (93.5%).
What were the preliminary safety findings?
The median number of treatment cycles in the combination and TACE arms were 12 (range, 1-32) and 2 (range, 1-8), respectively. Most patients who received TACE experienced a failure of treatment strategy with disease progression (56.8%); patients had a failure of treatment strategy with disease progression at a rate of 37.9% in the atezolizumab plus bevacizumab arm. Five patients in the TACE arm experienced a failure of treatment strategy with stable disease and 7 patients in the combination arm experienced treatment toxicity without disease progression.
“These are [the] first data showing efficacy of atezolizumab plus bevacizumab vs TACE in intermediate-stage [HCC],” Galle said in his conclusion. “Based on this assessment, we are fortunate to [be able to] continue the trial to the second [interim] analysis.”
Disclosures: Galle is a principal investigator for Bayer and Roche. He also received research funding from Roche/Genentech and holds speaker, consultant, or advisor roles with Bayer, Boston Scientific, AstraZeneca, Adaptimmune, BMS, Eisai, MSD, Sirtex, Lilly, Roche, and Guerbet.
References
- Galle PR, Bruix J, Kloeckner R, et al. IKF/ABC-HCC: a phase IIIb, randomized, multicenter, open-label trial of atezolizumab plus bevacizumab versus transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA51.
- The ABC-HCC trial: atezolizumab plus bevacizumab vs. transarterial chemoembolization (TACE) in intermediate-stage hepatocellular carcinoma. ClinicalTrials.gov. Updated January 7, 2025. Accessed October 20, 2025. https://clinicaltrials.gov/study/NCT04803994
