Evidence map›Paper›PMID 29063313›Full record

Trial reportBreast cancer research and treatment2018

Avelumab, an anti-PD-L1 antibody, in patients with locally advanced or metastatic breast cancer: a phase 1b JAVELIN Solid Tumor study.

Luc Y Dirix, Istvan Takacs, Guy Jerusalem, Petros Nikolinakos, Hendrik-Tobias Arkenau, Andres Forero-Torres, Ralph Boccia, Marc E Lippman, Robert Somer, Martin Smakal and 8 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 471 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
471citing papers in PubMed, 7 pooled it
29.9field-weighted citation impact, top 1% 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.

NCT01772004 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2013 to 2019Enrolled1,756ConditionsSolid TumorsArmsAvelumab
NCT04360941 phase1active not recruitingnot on this mapstarted 2020, after this paper: background citation

PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2020 to 2027Enrolled45ConditionsTriple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast CancerArmsPalbociclib, Avelumab
3 · Its place in the literature

Who cites it

471 citing papers in PubMed, 7 syntheses or guidelines pooled it, 750 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Efficacy and safety of a combination treatment of immune checkpoint inhibitors in metastatic breast cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Effect ofCancer science · 2023
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review

411 more citing papers are in PubMed but not listed here.

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

18 authors at 16 institutions in 5 countries.

Luc Y DirixSint Augustinus-University of Antwerp, Antwerp, Belgium. luc.dirix@gza.be.ORCID http://orcid.org/0000-0002-7792-9964
Istvan TakacsSemmelweis University, Budapest, Hungary.
Guy JerusalemCHU Sart Tilman Liege and Liege University, Liege, Belgium.
Petros NikolinakosUniversity Cancer & Blood Center, LLC, Athens, GA, USA.
Hendrik-Tobias ArkenauSarah Cannon Research Institute, London, UK.
Andres Forero-TorresUniversity of Alabama, Birmingham, AL, USA.
Ralph BocciaCenter for Cancer and Blood Disorders, Bethesda, MD, USA.
Marc E LippmanUniversity of Miami Miller School of Medicine, Miami, FL, USA.
Robert SomerCooper Hospital University Medical Center, Camden, NJ, USA.
Martin SmakalNemocnice Horovice, Onkologicke Oddelení, Horovice, Czech Republic.
Leisha A EmensThe John Hopkins University School of Medicine, Baltimore, MD, USA.
Borys HrinczenkoMichigan State University, East Lansing, MI, USA.
William EdenfieldGreenville Hospital System, Greenville, SC, USA.
Jayne GurtlerMetairie Oncologist LLC, Metairie, LA, USA.
Anja von HeydebreckMerck KGaA, Darmstadt, Germany.
Hans Juergen GroteMerck KGaA, Darmstadt, Germany.
Kevin ChinEMD Serono, Billerica, MA, USA.
Erika P HamiltonSarah Cannon Research Institute, Nashville, TN, USA.
Merck (Germany) · DECenter for Cancer and Blood Disorders · USCooper University Hospital · USJohns Hopkins University · USLittoral Research Group (United States) · USMichigan State University · USOno Pharmaceutical (United States) · USPrisma Health · USSarah Cannon · USSarah Cannon Research Institute · GBSemmelweis University · HUUniversity Cancer and Blood Center · USUniversity of Alabama at Birmingham · USUniversity of Antwerp · BEUniversity of Liège · BEUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAgents targeting programmed death receptor 1 (PD-1) or its ligand (PD-L1) have shown antitumor activity in the treatment of metastatic breast cancer (MBC). The aim of this study was to assess the activity of avelumab, a PD-L1 inhibitor, in patients with MBC.

methodsIn a phase 1 trial (JAVELIN Solid Tumor; NCT01772004), patients with MBC refractory to or progressing after standard-of-care therapy received avelumab intravenously 10 mg/kg every 2 weeks. Tumors were assessed every 6 weeks by RECIST v1.1. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Membrane PD-L1 expression was assessed by immunohistochemistry (Dako PD-L1 IHC 73-10 pharmDx).

resultsA total of 168 patients with MBC, including 58 patients with triple-negative breast cancer (TNBC), were treated with avelumab for 2-50 weeks and followed for 6-15 months. Patients were heavily pretreated with a median of three prior therapies for metastatic or locally advanced disease. Grade ≥ 3 treatment-related AEs occurred in 13.7% of patients, including two treatment-related deaths. The confirmed objective response rate (ORR) was 3.0% overall (one complete response and four partial responses) and 5.2% in patients with TNBC. A trend toward a higher ORR was seen in patients with PD-L1+ versus PD-L1- tumor-associated immune cells in the overall population (16.7% vs. 1.6%) and in the TNBC subgroup (22.2% vs. 2.6%).

conclusionAvelumab showed an acceptable safety profile and clinical activity in a subset of patients with MBC. PD-L1 expression in tumor-associated immune cells may be associated with a higher probability of clinical response to avelumab in MBC.

Indexed as

AdultAgedAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenDisease-Free SurvivalFemaleGene Expression Regulation, NeoplasticHumansMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalTriple Negative Breast NeoplasmsAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabB7-H1 AntigenCD274 protein, humanAvelumabMetastatic breast cancerPD-L1Second-lineTriple-negative breast cancer

Identifiers

PMID29063313
PMCPMC5807460
OpenAlexW2766673799

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.