PO4-03-YI Efficacy and safety of atezoliumab/bevacizumab for hepatocellular carcinoma in a real-world prospective cohort: a 2024 update

Background and aims: Atezolizumab/bevacizumab (atezo/bev) is a standard-of-care for patients with unresectable hepatocellular carcinoma. Most efficacy and safety data, however, stem from clinical trials, with fewer evidence from real-world practice. We aimed to provide real-world clinical data of patients with HCC treated with atezo/bev. Method: We analyzed clinical data and outcomes for patients with enrolled in the ARTE database, a nationwide, multicenter Italian dataset focused on immunotherapy treatments for HCC, covering the period from March 2022 to November 2024. The ARTE study group prospectively collects data from patients who began atezo/bev therapy outside the context of clinical trials. Results: Data from 397 patients across 15 centers were included. The majority had advanced HCC (59.9%). Sixty patients (15.1%) presented with one or more conditions outside the IMbrave150 enrollment criteria (thrombocytopenia <70,000/mmc [n=26], concurrent/recent malignancy [n=13], concurrent anticoagulation [n=9], arrhythmia [n=8], HIV infection [n=4], chronic heart failure [n=2]). Hepatitis C virus (HCV) was the most common etiology (45.1%), followed by metabolic-associated steatotic liver disease (MASLD, 33.0%), alcohol-related liver disease (ALD, 27.7%), and hepatitis B virus (HBV, 15.9%). 103 patients (25.9%) had multiple risk factors. Performance status (ECOG-PS) >0, macrovascular invasion (MVI), extrahepatic spread, and alpha-fetoprotein (AFP) >400 ng/ml were observed in 31.5%, 32.7%, 39.0%, and 28.0% of patients, respectively. Fifty-three patients (13.4%) received non-systemic therapies after starting atezo/bev, including surgical (transplant n=8, resection 145 EASL Liver Cancer Summit 2025 n=4), percutaneous (n=9), and trans-arterial procedures (n=18), or non-liver-directed radiotherapy (n=20). Median overall and progression-free survivals were 20.4 (95% CI 17.8-23.0) and 9.6 months (8.4-12.8), respectively. ECOG-PS >0, MVI, AFP >400 ng/ml, ALBI grade >1, and neutrophils-to-lymphocytes ratio >3 were independent negative prognostic factors. The most common treatment-related adverse events (AEs) included fatigue (45.1%), hypertension (24.7%), anorexia (17.1%), and diarrhea (13.9%). Most common treatment-related Grade 3-4 AEs were: hypertension (5.3%), variceal bleeding (3.5%), increased aminotransferases (2.8%), and digestive nonvariceal bleeding (2.5%) Conclusion: Real-world findings confirm previous efficacy and safety data for atezo/bev. Multiple HCC risk factors, comorbidities, and combination with surgical/locoregional treatments are common in clinical practice and warrant dedicated studies.