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 (14)
ABSTRACT
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.
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