Evidence map›Paper›PMID 33323462›Full record

ArticleJournal for immunotherapy of cancer2020

Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with human papillomavirus-associated malignancies.

Julius Strauss, Margaret E Gatti-Mays, Byoung Chul Cho, Andrew Hill, Sébastien Salas, Edward McClay, Jason M Redman, Houssein A Sater, Renee N Donahue, Caroline Jochems and 13 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal for immunotherapy of cancer, 2020. 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 94 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 1 pooled it
17.6field-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.

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
NCT03427411 phase2completednot on this map

Phase II Trial of M7824 in Subjects With HPV Associated Malignancies

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2018 to 2022Enrolled57ConditionsHuman Papilloma Virus, Cervical Cancer, Oropharyngeal Cancer, Anal CancerArmsM7824
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 1 synthesis or guideline pooled it, 154 citations in OpenAlex.

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  10. Redefining oropharyngeal cancer in the HPV era: integrating precision medicine and immunotherapeutic frontiers.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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34 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

23 authors at 7 institutions in 5 countries.

Julius Strauss *Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Margaret E Gatti-Mays *Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-8914-2897
Byoung Chul ChoYonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-5562-270X
Andrew HillTasman Oncology Research Ltd, Southport, Queensland, Australia.
Sébastien SalasCEPCM Assistance Publique des Hôpitaux de Marseille; Aix-Marseille Université, Marseille, France.
Edward McClayCalifornia Cancer Associates for Research and Excellence, Encinitas, California, USA.
Jason M RedmanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Houssein A SaterGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-1975-3726
Renee N DonahueLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Caroline JochemsLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-9000-9855
Elizabeth LampingGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Andrea BurmeisterGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Jennifer L MartéGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Lisa M CordesGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-3833-4084
Marijo BilusicGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0003-1020-689X
Fatima KarzaiGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Laureen S OjalvoEMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; an affiliate of Merck KGaA, Darmstadt, Germany.
Genevieve JehlMerck KGaA, Darmstadt, Germany.
P Alexander RolfeEMD Serono Research & Development Institute, Inc, Billerica, Massachusetts, USA; an affiliate of Merck KGaA, Darmstadt, Germany.
Christian S HinrichsGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Ravi A MadanGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-5106-8636
Jeffrey SchlomLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0001-7932-4072
James L GulleyGenitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA gulleyj@mail.nih.gov.ORCID 0000-0002-6569-2912
National Institutes of Health · USMerck (Germany) · DEAix-Marseille Université · FRCalifornia Cancer Associates for Research and Excellence · USLeidos (United States) · USTrans Tasman Radiation Oncology Group · AUYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of transforming growth factor (TGF)-βRII (a TGF-β 'trap') fused to a human IgG1 mAb blocking programmed cell death ligand 1. This is the largest analysis of patients with advanced, pretreated human papillomavirus (HPV)-associated malignancies treated with bintrafusp alfa.

methodsIn these phase 1 (NCT02517398) and phase 2 trials (NCT03427411), 59 patients with advanced, pretreated, checkpoint inhibitor-naive HPV-associated cancers received bintrafusp alfa intravenously every 2 weeks until progressive disease, unacceptable toxicity, or withdrawal. Primary endpoint was best overall response per Response Evaluation Criteria in Solid Tumors (RECIST) V.1.1; other endpoints included safety.

resultsAs of April 17, 2019 (phase 1), and October 4, 2019 (phase 2), the confirmed objective response rate per RECIST V.1.1 in the checkpoint inhibitor-naive, full-analysis population was 30.5% (95% CI, 19.2% to 43.9%; five complete responses); eight patients had stable disease (disease control rate, 44.1% (95% CI, 31.2% to 57.6%)). In addition, three patients experienced a delayed partial response after initial disease progression, for a total clinical response rate of 35.6% (95% CI, 23.6% to 49.1%). An additional patient with vulvar cancer had an unconfirmed response. Forty-nine patients (83.1%) experienced treatment-related adverse events, which were grade 3/4 in 16 patients (27.1%). No treatment-related deaths occurred.

conclusionBintrafusp alfa showed clinical activity and manageable safety and is a promising treatment in HPV-associated cancers. These findings support further investigation of bintrafusp alfa in patients with advanced, pretreated HPV-associated cancers.

Indexed as

B7-H1 AntigenFemaleHumansMaleMiddle AgedNeoplasmsPapillomaviridaePapillomavirus InfectionsTransforming Growth Factor betaB7-H1 AntigenCD274 protein, humanTransforming Growth Factor betaprogrammed cell death 1 receptor

Identifiers

PMID33323462
PMCPMC7745517
OpenAlexW3110938402

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.