Evidence map›Paper›PMID 33792763›Full record

ReviewCancer chemotherapy and pharmacology2021

Clinical pharmacology strategies in supporting drug development and approval of antibody-drug conjugates in oncology.

Stephanie N Liu, Chunze Li

Open access · hybridAbstract readReview
In one paragraph

Review in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
1.8field-weighted citation impact, top 12% 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

18 citing papers in PubMed, 31 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

2 authors at 1 institution in 1 country.

Stephanie N LiuDepartment of Clinical Pharmacology, Genentech, Inc, 1 DNA Way, South San Francisco, CA, 94080, USA.
Chunze LiDepartment of Clinical Pharmacology, Genentech, Inc, 1 DNA Way, South San Francisco, CA, 94080, USA. li.chunze@gene.com.ORCID 0000-0002-8906-6553
Gene Therapy Laboratory · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-drug conjugates (ADCs) are important molecular entities in the treatment of cancer. These conjugates combine the target specificity of monoclonal antibodies with the potent anti-cancer activity of small-molecule therapeutics. The complex structure of ADCs poses unique challenges to characterize the drug's pharmacokinetics (PKs) and pharmacodynamics (PDs) since it requires a quantitative understanding of the PK and PD properties of multiple different molecular species (e.g., ADC conjugate, total antibody and unconjugated cytotoxic drug). As a result, clinical pharmacology strategy of an ADC is rather unique and dependent on the linker/cytotoxic drug technology, heterogeneity of the ADC, PK and safety/efficacy profile of the specific ADC in clinical development. In this review, we summarize the clinical pharmacology strategies in supporting development and approval of ADCs using the approved ADCs as specific examples to illustrate the customized approach to clinical pharmacology assessments in their clinical development.

Indexed as

AnimalsAntibodies, MonoclonalAntineoplastic AgentsAntineoplastic Agents, ImmunologicalDrug DevelopmentHumansImmunoconjugatesMedical OncologyNeoplasmsPharmacology, ClinicalAntibodies, MonoclonalAntineoplastic AgentsAntineoplastic Agents, ImmunologicalImmunoconjugatesAntibody–drug conjugateClinical pharmacologyDrug interactionExposure–response analysisPopulation pharmacokineticsQTc prolongationSpecific population

Identifiers

PMID33792763
PMCPMC8110483
OpenAlexW3149651509

What OpenQuestion holds

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LicenceCC BY
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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.