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- W2891111529 startingPage "TPS3110" @default.
- W2891111529 abstract "TPS3110 Background: Advanced hepatocellular carcinoma (HCC) accounts for 70% of diagnosed HCC. Tislelizumab (also known as BGB-A317) is a humanized, IgG4 monoclonal antibody with high affinity and binding specificity for programmed cell death receptor-1 (PD-1). Furthermore, tislelizumab was specifically engineered to minimize FcgR binding on macrophages, thereby abrogating antibody-dependent phagocytosis, a potential mechanism of T-cell clearance. A first-in-human, phase 1A/1B study (NCT02407990) demonstrated that single-agent tislelizumab was generally well tolerated and showed evidence of antitumor activity in patients with advanced solid tumors, including HCC. A recommended phase 3 dose of 200 mg administered intravenously (IV) every 3 weeks (Q3W) has been established for tislelizumab. Methods: This global, phase 3, randomized, multicenter, non-inferiority study (NCT03412773) was designed to evaluate the efficacy and safety of tislelizumab compared with sorafenib as a first-line treatment of advanced HCC. Adult patients, aged ≥18 years, with unresectable, histologically confirmed HCC, an ECOG score ≤1, Child-Pugh A classification, BCLC Stage C disease or BCLC Stage B disease that has relapsed after loco-regional therapy, and who have not received prior systemic therapy, are being enrolled. Approximately 640 patients from 100 international centers will be randomized (1:1) to receive tislelizumab 200 mg IV Q3W or sorafenib 400 mg orally BID. The primary outcome of this non-inferiority study is overall survival (OS) of patients treated with tislelizumab compared with OS of patients treated with sorafenib; secondary outcomes include objective response rate, progression-free survival, duration of response, time to progression, and quality-of-life outcomes. Safety/tolerability assessments include monitoring adverse events (AEs), including immune-related AEs, as well as physical examinations, vital signs, and electrocardiograms. Clinical trial information: NCT03412773." @default.
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- W2891111529 date "2018-05-20" @default.
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- W2891111529 title "A phase 3, randomized, open-label, multicenter study to compare the efficacy and safety of tislelizumab, an anti-PD-1 antibody, versus sorafenib as first-line treatment in patients with advanced hepatocellular carcinoma." @default.
- W2891111529 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.tps3110" @default.
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