Evidence map›Paper›PMID 31749251›Full record

ArticleCPT: pharmacometrics & systems pharmacology2020

Integrated Two-Analyte Population Pharmacokinetic Model of Polatuzumab Vedotin in Patients With Non-Hodgkin Lymphoma.

Dan Lu, Tong Lu, Leonid Gibiansky, Xiaobin Li, Chunze Li, Priya Agarwal, Colby S Shemesh, Rong Shi, Randall C Dere, Jamie Hirata and 4 more

Open access · goldAbstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 10% 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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 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

14 authors at 1 institution in 1 country.

Dan LuGenentech Inc., South San Francisco, California, USA.ORCID 0000-0003-4531-3599
Tong LuGenentech Inc., South San Francisco, California, USA.ORCID 0000-0001-5899-6857
Leonid GibianskyQuantPharm LLC, North Potomac, Maryland, USA.
Xiaobin LiGenentech Inc., South San Francisco, California, USA.
Chunze LiGenentech Inc., South San Francisco, California, USA.
Priya AgarwalGenentech Inc., South San Francisco, California, USA.
Colby S ShemeshGenentech Inc., South San Francisco, California, USA.
Rong ShiGenentech Inc., South San Francisco, California, USA.
Randall C DereGenentech Inc., South San Francisco, California, USA.
Jamie HirataGenentech Inc., South San Francisco, California, USA.
Dale MilesGenentech Inc., South San Francisco, California, USA.ORCID 0000-0002-6351-0441
Pascal ChanuGenentech/Roche, Lyon, France.
Sandhya GirishGenentech Inc., South San Francisco, California, USA.
Jin Yan JinGenentech Inc., South San Francisco, California, USA.
Roche (France) · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A two-analyte integrated population pharmacokinetic (PK) model that simultaneously describes concentrations of antibody-conjugated monomethyl auristatin E (acMMAE) and unconjugated MMAE following repeated administrations of polatuzumab vedotin (pola) was developed based on data from four clinical studies of pola in patients with non-Hodgkin lymphoma. A two-compartment model with a nonspecific, time-dependent linear clearance, a linear time-dependent exponentially declining clearance, and a Michaelis-Menten clearance provided a good fit of the acMMAE plasma PK profiles. All three acMMAE elimination pathways contributed to the input to the central compartment of unconjugated MMAE, which was also described by a two-compartment model. Population PK parameters, covariate effects, and interindividual variability of model parameters were estimated. The impact of clinically relevant covariates on PK exposures of each analyte were quantified and reported to support key label claims.

Indexed as

Models, BiologicalAntibodies, MonoclonalClinical Trials as TopicHumansImmunoconjugatesLinear ModelsLymphoma, Non-HodgkinTime FactorsAntibodies, MonoclonalImmunoconjugatespolatuzumab vedotin

Identifiers

PMID31749251
PMCPMC6966185
OpenAlexW2991590450

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.