Evidence map›Paper›PMID 36568239›Full record

ArticleFrontiers in oncology2022

Identification of

Alexander Spira, Ahmad Awada, Nicolas Isambert, David Lorente, Nicolas Penel, Yue Zhang, Laureen S Ojalvo, Christine Hicking, P Alexander Rolfe, Christian Ihling and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02517398 (A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

NCT02517398 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2015 to 2022Enrolled600ConditionsSolid TumorsArmsMSB0011359C
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. 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

13 authors at 7 institutions in 5 countries.

Alexander SpiraDepartment of Medical Oncology, Virginia Cancer Specialists, Fairfax, VA, United States.
Ahmad AwadaMedical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Nicolas IsambertDepartment of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.
David LorenteDepartment of Medical Oncology, Hospital Universitari I Politècnic La Fe, Valencia, Spain.
Nicolas PenelDepartment of Medical Oncology, Centre Oscar Lambret, Lille, France.
Yue ZhangEMD Serono Research & Development Institute, Inc, an Affiliate of Merck KGaA, Billerica, MA, United States.
Laureen S OjalvoEMD Serono Research & Development Institute, Inc, an Affiliate of Merck KGaA, Billerica, MA, United States.
Christine HickingMerck Healthcare KGaA, Darmstadt, Germany.
P Alexander RolfeEMD Serono Research & Development Institute, Inc, an Affiliate of Merck KGaA, Billerica, MA, United States.
Christian IhlingMerck Healthcare KGaA, Darmstadt, Germany.
Isabelle DussaultEMD Serono Research & Development Institute, Inc, an Affiliate of Merck KGaA, Billerica, MA, United States.
George LockeEMD Serono Research & Development Institute, Inc, an Affiliate of Merck KGaA, Billerica, MA, United States.
Christian BorelDepartment of Medical Oncology, Centre Paul Strauss, Strasbourg, France.
Research & Development Institute · USMerck (Germany) · DECentre Georges François Leclerc · FRHospital Universitari i Politècnic La Fe · ESUniversité de Lille · FRUniversité Libre de Bruxelles · BEVirginia Cancer Specialists · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: We report the clinical activity, safety, and identification of a predictive biomarker for bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGFβRII (a TGF-β "trap") fused to a human IgG1 mAb blocking PD-L1, in patients with advanced triple-negative breast cancer (TNBC). Methods: In this expansion cohort of a global phase 1 study, patients with pretreated, advanced TNBC received bintrafusp alfa 1200 mg every 2 weeks intravenously until disease progression, unacceptable toxicity, or withdrawal. The primary objective was confirmed best overall response by RECIST 1.1 assessed per independent review committee (IRC). Results: As of May 15, 2020, a total of 33 patients had received bintrafusp alfa, for a median of 6.0 (range, 2.0-48.1) weeks. The objective response rate was 9.1% (95% CI, 1.9%-24.3%) by IRC and investigator assessment. The median progression-free survival per IRC was 1.3 (95% CI, 1.2-1.4) months, and median overall survival was 7.7 (95% CI, 2.1-10.9) months. Twenty-five patients (75.8%) experienced treatment-related adverse events (TRAEs). Grade 3 TRAEs occurred in 5 patients (15.2%); no patients had a grade 4 TRAE. There was 1 treatment-related death (dyspnea, hemolysis, and thrombocytopenia in a patient with extensive disease at trial entry). Responses occurred independently of PD-L1 expression, and tumor RNAseq data identified Conclusions: Bintrafusp alfa showed clinical activity and manageable safety in patients with heavily pretreated advanced TNBC. ClinicalTrialsgov identifier: NCT02517398.

Indexed as

bintrafusp alfaPD-L1TGF-βtriple-negative breast cancertumor microenvironment

Identifiers

PMID36568239
PMCPMC9773992
OpenAlexW4311870276

What OpenQuestion holds

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LicenceCC BY
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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.