Clinical Pharmacology Overview of Tislelizumab in Patients With Advanced Tumors With a Focus on Racial Impact

• DOI: 10.1111/cts.70221
• Publication Date: 2025-04-26T18:04:54Z
• Authors: Tian Yu; Chi‐Yuan Wu; Srikumar Sahasran...; Xianbin Tian; Ying Fei Li; Zhiyu Tang; Yanfei Yang; Ya Wan; Quting Zhang; Patrick Schnell; Ariadna Mendoza‐N...; Ramil Abdrashitov; William D. Hanley; Nageshwar Budha

ABSTRACT Tislelizumab, an anti‐programmed cell death protein‐1 monoclonal antibody, has demonstrated improved survival over the standard of care for multiple cancers. However, tislelizumab's effectiveness across different racial/ethnicity groups warrants further evaluation. This clinical pharmacology overview includes pharmacokinetic properties, correlations with efficacy and safety, immunogenicity, a focus on racial impact. Non‐compartmental analysis was conducted using data from Asian White patients enrolled in BGB‐A317‐001 BGB‐A317‐102. Population analyses used pooled 12 studies to evaluate impact intrinsic/extrinsic factors including race effect. Exposure–efficacy/exposure–safety relationships immunogenicity assessments were evaluated phase III BGB‐A317‐302/‐303 studies. Tislelizumab exhibited dose‐proportional pharmacokinetics, there no clinically meaningful differences parameters at 200 mg once every 3 weeks between ( n = 12, 83% patients) BGB‐A317‐102 20, 100% Chinese patients); not significant covariate. No relevant exposure–efficacy/−safety observed BGB‐A317‐302/‐303. Incidence anti‐drug antibodies (ADAs) similar patients. The presence ADAs efficacy, or safety. There ADA characteristics advanced cancer dependency Data extensive program tislelizumab support use broad patient populations tumor types.