Evidence map›Paper›PMID 40286320›Full record

ArticleClinical and translational science2025

Alternative Dosing Regimens of Tislelizumab Using a Pharmacometrics Model-Based Approach.

Ahsan Rizwan, Hugh Giovinazzo, Tian Yu, Yuying Gao, Kun Wang, Fengyan Xu, Ya Wan, Jun Wang, Srikumar Sahasranaman, Marcia Campbell 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. Trial
  2. Trial
  3. Review
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.

Ahsan RizwanClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.ORCID 0000-0001-6638-1019
Hugh GiovinazzoClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.
Tian YuClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.ORCID 0000-0002-4044-7902
Yuying GaoPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.ORCID 0009-0009-0208-3210
Kun WangPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.
Fengyan XuPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.ORCID 0009-0005-9037-1765
Ya WanScientific Programming, BeiGene (Shanghai) Co., Ltd., Shanghai, China.
Jun WangGlobal Statistics and Data Sciences, BeiGene (Beijing), Co., Ltd., Beijing, China.
Srikumar SahasranamanClinical Pharmacology and Pharmacometrics, BeiGene USA, Inc., San Carlos, California, USA.ORCID 0000-0002-0762-2967
Marcia CampbellRegulatory Affairs, BeiGene (Canada) ULC, Toronto, Ontario, Canada.
Patrick SchnellProduct Safety, BeiGene USA, Inc., Ridgefield, New Jersey, USA.
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

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tislelizumab 200 mg once every 3 weeks (Q3W) is approved for the treatment of multiple cancers. We used a model-based approach to propose three alternative dosing regimens, 150 mg Q2W, 300 mg Q4W, and 400 mg Q6W, with the aims of providing flexible treatment regimens compatible with background chemotherapy and/or reducing infusion visits. A previously developed population pharmacokinetic model was used to simulate pharmacokinetic exposure of the alternative regimens. Regulatory guidance on alternative dosing was used to define pharmacokinetics-based criteria. Alternative doses were selected by simulation, exposure matching, and comparison to the reference regimen of 200 mg Q3W. Deviations from pharmacokinetics-based criteria were bridged using appropriate safety and efficacy references and exposure-response analyses. All three alternative dosing regimens produced comparable exposures versus 200 mg Q3W. Although simulated peak serum concentration (C

Indexed as

Antibodies, Monoclonal, HumanizedModels, BiologicalNeoplasmsAdultComputer SimulationDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, Humanizedtislelizumabalternative doseanti–PD‐1exposure–responseimmunotherapypharmacokineticspharmacometricstislelizumab

Identifiers

PMID40286320
PMCPMC12033006

What OpenQuestion holds

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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.