Association of Metabolic‐Associated Steatotic Liver Disease With Clinical Outcomes of Durvalumab and Tremelimumab in Advanced Hepatocellular Carcinoma Patients: A Multicenter Study

AIM: This study aimed to evaluate the association between the efficacy of durvalumab plus tremelimumab (Dur/Tre) and metabolic dysfunction-associated steatotic liver disease (MASLD) in patients with hepatocellular carcinoma (HCC). METHODS: A total of 239 patients with HCC who received Dur/Tre between March 2023 and October 2024 at multiple institutions in Japan were retrospectively analyzed. Patients were categorized into three groups based on underlying liver disease: viral-related HCC (n = 126), MASLD-related HCC (n = 30), and nonviral, non-MASLD HCC (n = 83). RESULTS: The overall response rates (ORR) were 17.5%, 16.7%, and 19.3% in viral-related HCC, MASLD-related HCC, and nonviral, non-MASLD HCC, respectively. The disease control rates (DCR) were 44.4%, 46.7%, and 51.8%, respectively. No significant differences in ORR (p = 0.6) or DCR (p = 0.9) were observed among the three groups. The median PFS was 3.7 months (95% CI, 2.8-4.9) in patients with viral-related HCC, 3.6 months (95% CI, 2.3-4.8) in patients with MASLD-related HCC, and 4.4 months (95% CI, 2.6-5.8) in patients with nonviral, non-MASLD HCC. The median OS was 14.4 months (95% CI, 9.8-NA) in patients with viral-related HCC and 11.0 months (95% CI, 6.4-NA) in patients with MASLD-related HCC, whereas it was not reached in patients with nonviral, non-MASLD HCC. No statistically significant differences in PFS (p = 1.0) and OS (p = 0.3) were found among the groups. CONCLUSIONS: Dur/Tre showed comparable efficacy in MASLD-related HCC and other etiologies, warranting confirmation in larger cohorts.