The efficacy and safety of donafenib combined with anti–PD-1 antibody plus transarterial chemoembolization (TACE) as first-line treatment for patients (pts) with hepatocellular carcinoma (HCC): A retrospective study.

e16219 Background: Transarterial chemoembolization (TACE), anti-angiogenic therapy, immune checkpoint inhibitor (ICI) therapy, and their combination strategies have an important role in decreasing tumor disease progression and improving survival in HCC patients. Donafenib has been approved as a standard first-line systemic therapy for patients with unresectable HCC in China, combination therapies have shown favorable results. However, triple therapy with donafenib, anti-PD-1 antibodies, and transarterial therapy has not yet been investigated. Here, we describe our preliminary results regarding the efficacy and safety of donafenib combined anti-PD-1 antibody and TACE as first-line therapy for patients with HCC. Methods: We retrospectively reviewed the data of pts who had received the combination therapy of donafenib, anti-PD-1 antibody and TACE as fist-line therapy in routine practice at The First Affiliated Hospital of Fujian Medical University from December 2022 to August 2024. Efficacy was evaluated using objective response rates based on RECIST1.1 criteria. Results: Thirty patients were enrolled in this study. The median age was 64 years (range, 41–68), 86.7% were males, 20 patients(66.7%) had Child-Pugh scores of B, 26 patients (86.7%) had ECOG PS scores of 1, 76.7% had tumor diameters＞5cm, 50.0% had tumor numbers＞3, 6 patients (20.0%) in BCLC stage B and 22 patient (73.3%) in BCLC stage C, 83.3% with HBV, 63.3% had serum a-fetoprotein levels ≥400 ng/mL, 17patients (56.7%) with tumor thrombus and 46.7% had metastasis. The median follow-up time for the entire patient cohort was 20.4 months, The ORR and DCR were 50.0% and 93.3% by RECIST 1.1, respectively; At the data cut-off, the 1 year PFS rate was 53.4%, the mOS had not yet been achieved and 1 year OS rate was 96.7%. Among the overall population, 30 pts (100.0%) had treatment-related adverse events (TRAEs) of any grade. The most common treatment-related adverse events were alanine aminotransferase increased (86.7%), aspartate aminotransferase increased (80.0%), total bilirubin increased (80.0%) and lymphocyte count decreased (70.0%). Conclusions: The combination therapy of donafenib and anti-PD-1 antibody plus TACE showed promising efficacy and acceptable safety as the first-line treatment for HCC in this retrospective study.