Efficacy and safety of durvalumab plus tremelimumab for unresectable hepatocellular carcinoma in Thailand: A real-world multicenter observational study.

539 Background: Durvalumab plus tremelimumab (Durva/Treme) andatezolizumab plus bevacizumab are preferable first-line therapy for unresectable hepatocellular carcinoma (uHCC). This study aimed to evaluate the efficacy and safety of Durva/Treme in real world setting. Methods: Fifty patients with uHCC who enrolled in the expanded access program (EAP) for Durva/Treme as the first-line treatment from 12 centers in Thailand were included. Analysis was assessed for objective response rate (ORR), survival, and adverse events. We also compared data with the HIMALAYA study. Results: Median follow-up time was 9.8 months. There were 24 patients alive and 26 patients deceased. The median age was 62 years. Majority of the patients were male (80%). Hepatitis B, C and non-viral cause were identified in 44%, 30%, and 26%, respectively. Ninety-two percent of patients had Child-Pugh A, while 8% had Child-Pugh B(7). Macrovascular invasion was found in 24% of cases. The full data on efficacy and safety were summarized in table below. Conclusions: To date,this is the largest real-world data of Durva/Treme in the first-line treatment of uHCC. Our study demonstrated that Durva/Treme was effective but had lower ORR and higher liver toxicities than what reported in the HIMALAYA study. EAP (N=50) HIMALAYA (N=393) Response by RECIST1.1, n (%) CR PR SD PD Not evaluable 2(4)4(8)24(48)18(36)2(4) 12(3.1)67(17)157(39.9)157(39.9) - ORR (%) 12 20.1 DCR (%) 60 60.1 mPFS (range), mo 5.36(0.2-12.5) 3.78(3.7-5.3) mOS (range), mo NA 16.4 (14.2-19.6) Adverse events, n (%) A ny grade G rade > 3 A ny grade G rade > 3 Any AE Diarrhea Rash AST elevation ALT elevation Increase bilirubin Hypothyroidism Myocarditis Myositis 37(74) 3(6) 12(24) 23(46) 21(42) 8(16) 7(14) 1(2) 1(2) 12(24) 1(2) 0 6(12) 7(14) 4(8) 01(2) 1(2) 378(97.4)103(26.5) 87(22.4) 48(12.4) 36(9.3) 20(5.2) 47(12.1) -- 196(50.5)17(4.4) 6(1.5) 20(5.2) 10(2.6) 3(0.8) 02(0.5) 3(0.8)