Evidence map›Paper›PMID 34009501›Full record

ArticleTargeted oncology2021

Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients with Esophageal Adenocarcinoma: Results from a Phase 1 Cohort.

Benjamin Tan, Adnan Khattak, Enriqueta Felip, Karen Kelly, Patricia Rich, Ding Wang, Christoph Helwig, Isabelle Dussault, Laureen S Ojalvo, Nicolas Isambert

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Targeted oncology, 2021. 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 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 7% 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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  16. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
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  20. Molecular Pathways and Mechanisms of TGFβ in Cancer Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
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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

10 authors at 9 institutions in 5 countries.

Benjamin TanWashington University School of Medicine, St Louis, MO, USA.
Adnan KhattakFiona Stanley Hospital, Perth, WA, Australia.
Enriqueta FelipVall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), IOB-Quiron, UVic-UCC, Barcelona, Spain.
Karen KellyUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Patricia RichCancer Treatment Centers of America, Atlanta, GA, USA.
Ding WangHenry Ford Cancer Institute, Detroit, MI, USA.
Christoph HelwigMerck KGaA, Darmstadt, Germany.
Isabelle DussaultEMD Serono Research & Development Institute, Inc., Billerica, MA, USA.
Laureen S OjalvoEMD Serono Research & Development Institute, Inc., Billerica, MA, USA.
Nicolas IsambertPoitiers University Hospital, 2 rue de la Miléterie, BP 577, 86021, Poitiers, France. nicolas.isambert@chu-poitiers.fr.
Merck (Germany) · DECancer Treatment Centers of America · USFiona Stanley Hospital · AUHenry Ford Hospital · USResearch & Development Institute · USUniversité de Poitiers · FRUniversity of California, Davis · USVall d'Hebron Institute of OncologyWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEsophageal adenocarcinoma patients have limited treatment options. TGF-β can be upregulated in esophageal adenocarcinoma, and blocking this pathway may enhance clinical response to PD-(L)1 inhibitors. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-βRII receptor (a TGF-β "trap") fused to a human IgG1 mAb blocking PD-L1.

objectiveThe objective of this study was to investigate the efficacy and safety of bintrafusp alfa in patients with advanced, post-platinum esophageal adenocarcinoma, unselected for PD-L1 expression. PATIENTS AND

methodsIn this phase 1 study, patients with post-platinum, PD-L1-unselected esophageal adenocarcinoma received bintrafusp alfa 1200 mg every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was confirmed best overall response per RECIST 1.1 by independent review committee (IRC).

resultsBy the database cutoff of 24 August 2018, 30 patients (80.0% had two or more prior anticancer regimens) received bintrafusp alfa for a median of 6.1 weeks. The confirmed objective response rate (ORR) per IRC was 20.0% (95% CI 7.7-38.6); responses lasted 1.3-8.3 months. Most responses (83.3%) occurred in tumors with an immune-excluded phenotype. Investigator-assessed confirmed ORR was 13.3% (95% CI 3.8-30.7). Nineteen patients (63.3%) had treatment-related adverse events: seven patients (23.3%) had grade 3 events; no grade 4 events or treatment-related deaths occurred.

conclusionsBintrafusp alfa showed signs of clinical efficacy with a manageable safety profile in patients with heavily pretreated, advanced esophageal adenocarcinoma. CLINICAL TRIALS REGISTRATION: NCT02517398.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalB7-H1 AntigenCohort StudiesEsophageal NeoplasmsHumansMaleMiddle AgedTransforming Growth Factor betaAntineoplastic Agents, ImmunologicalB7-H1 AntigenTransforming Growth Factor beta

Identifiers

PMID34009501
PMCPMC8266790
OpenAlexW3162081323

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.