Proffered Paper Session 1 – Part 2

At ESMO GI 2025, Dr Ana-Maria Bucalau, digestive oncologist at HUBruxelles, provided MediMix with an overview of the proffered paper session 1. 

The TALENTACE study was a Phase 3, randomised, open-label trial that evaluated the combination of on-demand TACE plus systemic therapy (atezolizumab and bevacizumab) versus on-demand TACE alone in treatment-naive patients with unresectable HCC. The primary endpoint, TACE PFS, was achieved, showing a benefit for the combination therapy. Secondary endpoints, including PFS according to RECIST 1.1, were also positive. However, OS did not show a significant benefit, although the data for OS remains immature and will be presented later. The study, primarily conducted in Asia, involved patients with intermediate to high tumour burden, predominantly due to viral hepatitis B. Treatment-related adverse events were more common in the combination arm due to the addition of systemic therapy. Despite the positive results for TACE PFS, several questions remain regarding the number of TACE procedures and the duration of systemic treatment.

The CheckMate 9DW study presented important data on QoL and safety, particularly in relation to patients requiring high-dose steroid treatments. QoL, measured using the FACT-Hep test, showed positive results for the NIVO-IPI combination, with a favourable time to symptom deterioration. AEs primarily occurred within the first three months, with hepatic and dermatological issues emerging early on. Approximately 80% of patients experienced treatment-related AEs, 30% of which were grade 3 or 4, and 18% discontinued treatment due to these events. About 29% received high-dose steroids for immune-related AEs. Despite these challenges, the study demonstrated that discontinuation of treatment or steroid use did not impact the efficacy of the treatment. OS for patients was around 27-28 months, with the ITT population showing a survival of 23.7 months, offering reassurance for patients requiring such interventions.