Evidence map›Paper›PMID 31152605›Full record

Trial reportClinical pharmacology and therapeutics2019

Population Pharmacokinetic Modeling and Exposure-Response Assessment for the Antibody-Drug Conjugate Brentuximab Vedotin in Hodgkin's Lymphoma in the Phase III ECHELON-1 Study.

Ajit Suri, Diane R Mould, Gregory Song, Graham P Collins, Christopher J Endres, Jesús Gomez-Navarro, Karthik Venkatakrishnan

Open access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. 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

7 authors at 5 institutions in 3 countries.

Ajit SuriMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
Diane R MouldProjections Research, Inc., Phoenixville, Pennsylvania, USA.
Gregory SongMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
Graham P CollinsOxford Cancer and Haematology Centre, Oxford University Hospital, Oxford, UK.
Christopher J EndresSeattle Genetics, Inc., Bothell, Washington, USA.
Jesús Gomez-NavarroMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
Karthik VenkatakrishnanMillennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
Millennium Engineering and Integration (United States) · USTakeda (United States) · USCancer Research UK Oxford Centre · GBPhoenixville Hospital · USSeagen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The efficacy of the CD30-directed antibody-drug conjugate (ADC) brentuximab vedotin was established in combination with chemotherapy as frontline treatment for advanced classical Hodgkin's lymphoma in the randomized phase III ECHELON-1 study. Population pharmacokinetic (PK) and exposure-response models were developed to quantify sources of PK variability and relationships between exposure and safety/efficacy end points in ECHELON-1. The influence of patient-specific factors on the PK of the ADC and the microtubule-disrupting payload monomethyl auristatin E (MMAE) was investigated; none of the significant covariates had a clinically relevant impact. Exposure-response analyses evaluated relationships between time-averaged area under the curve (AUC; ADC, MMAE) and efficacy end points (ADC) or safety parameters (ADC, MMAE). Exposure-efficacy analyses supported consistent treatment benefit with brentuximab vedotin across observed exposure ranges. Exposure-safety analyses supported the recommended brentuximab vedotin starting dose (1.2 mg/kg every 2 weeks), and effective management of peripheral neuropathy and neutropenia with dose modification/reduction and febrile neutropenia with granulocyte colony-stimulating factor primary prophylaxis.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalArea Under CurveBrentuximab VedotinChemotherapy-Induced Febrile NeutropeniaDose-Response Relationship, DrugFemaleGranulocyte Colony-Stimulating FactorHodgkin DiseaseHumansMaleMiddle AgedNeutropeniaAntineoplastic Agents, ImmunologicalBrentuximab VedotinGranulocyte Colony-Stimulating Factormonomethyl auristatin EOligopeptides

Identifiers

PMID31152605
PMCPMC6896233
OpenAlexW2947505996

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.