ESMO GI 2025 | TALENTACE: TACE combined with atezolizumab + bevacizumab in uHCC

TALENTACE is a phase 3 trial that tested the combination of atezolizumab plus bevacizumab with on-demand TACE in patients with intermediate stage HCC, so patients with liver limited disease with let’s say high tumor burn and patients with high risk of disease progression. This trial is a randomized phase 3, so patients receive on-demand TACE in both arms and atezolizumab plus bevacizumab in the experimental arm versus control. This is an Asian study conducted in Japan and China, and at ESMO GI, the progression-free survival data were presented. The primary endpoints, the co-primary endpoints of the trial are TASPFS and OS. OS data are not mature so we will not be talking about overall survival. TACE PFS is a composite endpoint that evaluates radiographic disease progression but also in different ways so considering the liver lesions, the macrovascular invasion and other aspects and also includes the worsening of liver function. In this trial no centralized review of the imaging was predefined this can be an issue to me for progression-free survival as a primary endpoint. The trial is positive there is a clear benefit in progression free survival both measured according to this let’s say composite endpoint progression-free taste PFS and also according to the classical PFS according to RECIST 1.1 so the trial is positive in this sense. I mentioned that is an Asian trial conducted in China and Japan and 90% of the patients were from China so this is a mostly Chinese trial and 80% of the patients had the HBV etiology as expected for Chinese population. There is a clear benefit of combining TACE and atezolizumab plus bevacizumab also in terms of response. Responses are higher compared to taste alone and the authors use two criteria to evaluate responses the RECIST criteria and the recycle criteria that are specific for HCC similar in some way to the modified resist and using the criteria specific for HCC the response rate and the complete responses are much higher compared to the evaluation according to the RECIST 1.1 so for local regional therapy criteria that are specific for the liver are probably better and better capture the response. In terms of safety the combination seems to be well tolerated however the authors didn’t present any data regarding the duration of treatment with Atezo-Bev and the number of cases that patients received because this trial tested on-demand cases so patients received taste at at baseline. Actually, they should have received also taste before entering the child, but then they receive at baseline. But they could have received taste during the treatment with atezolizumab plus bevacizumab. And this can, we don’t know, but can raise some safety concerns related to the combination of taste and bevacizumab in terms of risk of bleeding or thrombosis, but we don’t have the data yet. Then, so these are the results that have been presented at ESMO GI, progression-free survival, response rate, and safety. And overall, this is a positive phase three, so there is a clear benefit in combining TACE and atezolizumab plus bevacizumab versus TACE alone in patients with a high tumor burden in the liver. However, before this can be considered a new option in clinical practice, I think we need to see more data in terms of safety, in terms of duration of treatment, in terms of number of tests. And also we have to see the overall survival data that are not mature at this time.