Evidence map›Paper›PMID 36330700›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

Model-based population pharmacokinetic analysis of tislelizumab in patients with advanced tumors.

Nageshwar Budha, Chi-Yuan Wu, Zhiyu Tang, Tian Yu, Lucy Liu, Fengyan Xu, Yuying Gao, Ruiying Li, Qiuyang Zhang, Ya Wan and 1 more

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.7field-weighted citation impact, top 14% of its field
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

15 citing papers in PubMed, 17 citations in OpenAlex.

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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

11 authors at 2 institutions in 2 countries.

Nageshwar BudhaClinical Pharmacology, BeiGene (USA), Inc., San Mateo, California, USA.
Chi-Yuan WuClinical Pharmacology, BeiGene (USA), Inc., San Mateo, California, USA.
Zhiyu TangClinical Pharmacology, BeiGene (USA), Inc., San Mateo, California, USA.
Tian YuClinical Pharmacology, BeiGene (USA), Inc., San Mateo, California, USA.
Lucy LiuPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.
Fengyan XuPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.
Yuying GaoPharmacometrics, Shanghai Qiangshi Information Technology Co., Ltd., Shanghai, China.
Ruiying LiClinical Pharmacology, BeiGene (Shanghai), Co., Ltd, Shanghai, China.
Qiuyang ZhangClinical Pharmacology, BeiGene (Shanghai), Co., Ltd, Shanghai, China.
Ya WanClinical Pharmacology, BeiGene (Shanghai), Co., Ltd, Shanghai, China.
Srikumar SahasranamanClinical Pharmacology, BeiGene (USA), Inc., San Mateo, California, USA.
Deltagen (United States) · USBeiGene (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tislelizumab, a humanized immunoglobulin G4 monoclonal antibody, is a programmed cell death protein 1 (PD-1) inhibitor designed to minimize Fc gamma receptor binding on macrophages to limit antibody-dependent phagocytosis, a potential mechanism of resistance to anti-PD-1 therapy. The pharmacokinetic (PK) profile of tislelizumab was analyzed with population PK modeling using 14,473 observed serum concentration data points from 2596 cancer patients who received intravenous (i.v.) tislelizumab at 0.5-10 mg/kg every 2 weeks or every 3 weeks (q3w), or a 200 mg i.v. flat dose q3w in 12 clinical studies. Tislelizumab exhibited linear PK across the dose range tested. Baseline body weight, albumin, tumor size, tumor type, and presence of antidrug antibodies were identified as significant covariates on central clearance, whereas baseline body weight, sex, and age significantly affected central volume of distribution. Sensitivity analysis showed that these covariates did not have clinically relevant effects on tislelizumab PK. Other covariates evaluated, including race (Asian vs. White), lactate dehydrogenase, estimated glomerular filtration rate, renal function categories, hepatic function measures and categories, Eastern Cooperative Oncology Group performance status, therapy (monotherapy vs. combination therapy), and line of therapy did not show a statistically significant impact on tislelizumab PK. These results support the use of tislelizumab 200 mg i.v. q3w without dose adjustment in a variety of patient subpopulations.

Indexed as

Antibodies, Monoclonal, HumanizedNeoplasmsAdministration, IntravenousBody WeightHumansAntibodies, Monoclonal, Humanizedtislelizumab

Identifiers

PMID36330700
PMCPMC9835120
OpenAlexW4308183799

What OpenQuestion holds

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Registered trials

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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.