Evidence map›Paper›PMID 33840050›Full record

ArticleTargeted oncology2021

Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Patients with Esophageal Squamous Cell Carcinoma: Results from a Phase 1 Cohort in Asia.

Chia-Chi Lin, Toshihiko Doi, Kei Muro, Ming-Mo Hou, Taito Esaki, Hiroki Hara, Hyun Cheol Chung, Christoph Helwig, Isabelle Dussault, Motonobu Osada and 1 more

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 NCT02699515 (A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
1.9field-weighted citation impact, top 11% 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.

NCT02699515 phase1completednot on this map

A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0011359C (M7824) in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications in Asia

TypeinterventionalSponsorMerck KGaA, Darmstadt, GermanyRan2016 to 2022Enrolled114ConditionsSolid TumorsArmsMSB0011359C
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
  2. Article
  3. A Bioimaging Study ofMolecular imaging and biology · 2026
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  10. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
    Review
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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

11 authors at 9 institutions in 5 countries.

Chia-Chi LinNational Taiwan University Hospital, Taipei, Taiwan.
Toshihiko DoiNational Cancer Center Hospital East, Kashiwa, Japan.
Kei MuroAichi Cancer Center Hospital, Nagoya, Japan.
Ming-Mo HouChang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan.
Taito EsakiNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Hiroki HaraSaitama Cancer Center, Saitama, Japan.
Hyun Cheol ChungYonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Christoph HelwigMerck KGaA, Darmstadt, Germany.
Isabelle DussaultEMD Serono Research and Development Institute, Inc., Billerica, MA, USA.
Motonobu OsadaMerck Biopharma Co., Ltd., Tokyo, Japan.
Shunsuke KondoNational Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. shkondo@ncc.go.jp.ORCID 0000-0001-9565-117X
Merck (Germany) · DEAichi Cancer Center · JPChang Gung University · TWNational Cancer Center Hospital East · JPNational Cancer Centre Japan · JPNational Hospital Organization Kyushu Cancer Center · JPNational Taiwan University Hospital · TWSaitama Cancer Center · JPYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with esophageal squamous cell carcinoma (SCC) have limited treatment options. Blocking transforming growth factor-β (TGFβ), which can be overexpressed in these tumors, may enhance responses to programmed cell death protein 1/programmed death-ligand 1 [PD-(L)1] inhibitors. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the TGFβ receptor II (TGFβRII) (a TGFβ "trap") fused to a human IgG1 monoclonal antibody blocking PD-L1.

objectiveThe objective of this study was to investigate the safety and efficacy of bintrafusp alfa in Asian patients with pretreated, PD-L1-unselected esophageal SCC. PATIENTS AND

methodsIn a phase 1 study, Asian patients with pretreated esophageal SCC received bintrafusp alfa 1200 mg every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. The primary endpoint was safety/tolerability with a goal of exploring clinical activity.

resultsBy the database cutoff of August 24, 2018, 30 patients (76.7% had two or more prior anticancer regimens) received bintrafusp alfa for a median of 6.1 weeks; two remained on treatment. Nineteen patients (63.3%) had treatment-related adverse events, seven (23.3%) with grade 3/4 events, and there were no treatment-related deaths. The confirmed objective response rate (ORR) per independent review was 10.0% (95% confidence interval [CI] 2.1-26.5); responses lasted 2.8-8.3 + months. All responses occurred in immune-excluded tumors. Investigator-assessed confirmed ORR was 20.0% (95% CI 7.7-38.6). Median overall survival was 11.9 months (95% CI 5.7-not reached).

conclusionsBintrafusp alfa demonstrated a manageable safety profile and efficacy in Asian patients with pretreated esophageal SCC. CLINICAL TRIALS REGISTRATION: NCT02699515.

Indexed as

AdultAgedAged, 80 and overAsiaB7-H1 AntigenEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaFemaleHumansMaleMiddle AgedTransforming Growth Factor betaB7-H1 AntigenTransforming Growth Factor beta

Identifiers

PMID33840050
PMCPMC8266718
OpenAlexW3154461273

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.