Evidence map›Paper›PMID 40286322›Full record

ArticleClinical and translational science2025

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

Tian Yu, Chi-Yuan Wu, Srikumar Sahasranaman, Xianbin Tian, Ying Fei Li, Zhiyu Tang, Yanfei Yang, Ya Wan, Quting Zhang, Patrick Schnell and 4 more

Abstract read
In one paragraph

Article in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Tian YuClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.ORCID 0000-0002-4044-7902
Chi-Yuan WuClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.
Srikumar SahasranamanClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.
Xianbin TianPK Sciences, Novartis Biomedical Research, Novartis Pharmaceutical, Inc., East Hanover, New Jersey, USA.
Ying Fei LiPharmacometrics, Oncology, Global Drug Development, Novartis Pharmaceutical, Inc., East Hanover, New Jersey, USA.
Zhiyu TangClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.
Yanfei YangClinical BA BeiGene (Shanghai) Co., Ltd., Shanghai, China.
Ya WanScientific Programming, BeiGene (Shanghai) Co., Ltd., Shanghai, China.
Quting ZhangScientific Programming, BeiGene (Shanghai) Co., Ltd., Shanghai, China.
Patrick SchnellGlobal Product Safety, BeiGene USA, Inc., Ridgefield Park, New Jersey, USA.
Ariadna Mendoza-NaranjoClinical Development, BeiGene UK, Ltd., London, UK.
Ramil AbdrashitovClinical Development, BeiGene USA, Inc., Fulton, Maryland, USA.
William D HanleyClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.
Nageshwar BudhaClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.ORCID 0009-0005-3373-657X

Funding

BeiGene Ltd
6 · The paper itself

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 tislelizumab's pharmacokinetic properties, correlations with efficacy and safety, and immunogenicity, with a focus on racial impact. Non-compartmental pharmacokinetic analysis was conducted using data from Asian and White patients enrolled in BGB-A317-001 and BGB-A317-102. Population pharmacokinetic analyses used pooled data from 12 clinical studies to evaluate the impact of intrinsic/extrinsic factors on tislelizumab's pharmacokinetic properties, including race effect. Exposure-efficacy/exposure-safety relationships and immunogenicity assessments were evaluated for the phase III BGB-A317-302/-303 studies. Tislelizumab exhibited dose-proportional pharmacokinetics, and there were no clinically meaningful differences in tislelizumab's pharmacokinetic parameters at 200 mg once every 3 weeks between BGB-A317-001 (n = 12, 83% White patients) and BGB-A317-102 (n = 20, 100% Chinese patients); race was not a significant covariate. No clinically relevant exposure-efficacy/-safety relationships were observed in BGB-A317-302/-303. Incidence of anti-drug antibodies (ADAs) was similar between Asian and White patients. The presence of ADAs was not clinically relevant for tislelizumab's pharmacokinetic properties, efficacy, or safety. There were no differences in tislelizumab's pharmacokinetic or ADA characteristics between Asian and White patients with advanced cancer and no clinically relevant exposure-efficacy/-safety dependency or impact of immunogenicity on efficacy and safety. Data from the extensive clinical program of tislelizumab support the use of tislelizumab across broad patient populations with relevant tumor types.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalNeoplasmsAsian PeopleClinical Trials, Phase III as TopicDose-Response Relationship, DrugFemaleHumansMaleTreatment OutcomeWhite PeopleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicaltislelizumabexposure–responseimmunogenicitypharmacokineticsrace impacttislelizumab

Identifiers

PMID40286322
PMCPMC12033005

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.