Tislelizumab (BeiGene) is a humanized monoclonal antibody that was designed to bind to the PD-1 receptor and prevent binding of PD-L1. In addition, tislelizumab was designed to minimize binding to Fc-gamma-receptors (FcyR) on macrophages. Preclinical studies found that binding to FcyR on macrophages compromises the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. BeiGene had initially established a partnership with Celgene to develop and commercialize tislelizumab in all major markets; however, following the news of Bristol-Myers Squibb’s acquisition of Celgene, the agreement was terminated and all rights were returned to BeiGene. Nonetheless, the drug’s development in hepatocellular carcinoma continues, and due to the failure of Opdivo’s (nivolumab; Bristol-Myers Squibb/Ono Pharmaceutical) Phase III CheckMate 459 trial (ClinicalTrials.gov identifier: NCT02576509), tislelizumab is currently the only PD-1/PD-L1 inhibitor in development specifically as a monotherapy for the first-line setting.
LIST OF FIGURES
9 Figure 1: Datamonitor Healthcare’s drug assessment summary of tislelizumab for HCC
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of tislelizumab for HCC
12 Figure 3: Tislelizumab sales for HCC across the US, Japan, and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Tislelizumab drug profile
7 Table 2: Trials of tislelizumab for HCC
8 Table 3: Tislelizumab for HCC – SWOT analysis
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