Evidence map›Paper›PMID 38471711›Full record

Trial reportJournal for immunotherapy of cancer2024

High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma.

Danny Rischin, Brett G M Hughes, Nicole Basset-Séguin, Dirk Schadendorf, Samantha Bowyer, Sabiha Trabelsi Messai, Friedegund Meier, Thomas K Eigentler, Victoria Casado Echarren, Brian Stein and 17 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02760498 (A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.5field-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.

NCT02760498 phase2completednot on this map

A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2016 to 2023Enrolled432ConditionsAdvanced Cutaneous Squamous Cell CarcinomaArmscemiplimab
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
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  8. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 17 institutions in 7 countries.

Danny RischinDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia danny.rischin@petermac.org.ORCID 0000-0002-3368-0386
Brett G M HughesRoyal Brisbane and Women's Hospital and University of Queensland, Brisbane, Queensland, Australia.
Nicole Basset-SéguinDepartment of Dermatology, Hôpital Saint-Louis, Paris, France.
Dirk SchadendorfUniversity Hospital Essen and Essen and German Cancer Consortium, Essen, Germany.ORCID 0000-0003-3524-7858
Samantha BowyerDepartment of Medical Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.
Sabiha Trabelsi MessaiDepartment of Dermatology, Grenoble Alpes University Hospital, Grenoble, France.
Friedegund MeierSkin Cancer Center at the University Cancer Centre Dresden and National Center for Tumor Diseases Dresden, Dresden, Germany.ORCID 0000-0003-4340-9706
Thomas K EigentlerDepartment of Dermatology, Venereology and Allergology, Charité Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-0019-2770
Victoria Casado EcharrenDepartment of Oncology, Oncohealth Institute, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain.
Brian SteinICON Cancer Centre, Adelaide, South Australia, Australia.
Marie Beylot-BarryDepartment of Dermatology, University Hospital of Bordeaux, Bordeaux, France.
Sophie DalacHospital Center University Dijon Bourgogne, Dijon, France.
Brigitte DrénoCHU de Nantes and University de Nantes, Nantes, France.
Michael R MigdenDepartments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Axel HauschildSchleswig-Holstein University Hospital, Kiel, Germany.
Chrysalyne D SchmultsDermatologic Surgery, Mohs Micrographic Surgery Center, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
Annette M LimDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Suk-Young YooRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Anne J PaccalyRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Apostolos PapachristosRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jenny-Hoa NguyenRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Emmanuel OkoyeRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Frank SeebachRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Jocelyn BoothRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Israel LowyRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Matthew G FuryRegeneron Pharmaceuticals, Inc, Tarrytown, New York, USA.
Alexander GuminskiDepartment of Medical Oncology, Royal North Shore Hospital, St Leonards, New South Wales, Australia.ORCID 0000-0003-3681-7015
Regeneron (United States) · USPeter MacCallum Cancer Centre · AUCentre Hospitalier Universitaire de Nantes · FRCharité - Universitätsmedizin Berlin · DEDana-Farber Cancer Institute · USEssen University Hospital · DEHôpital Saint-Louis · FRHospital Universitario Fundación Jiménez Díaz · ESNational Cancer Centre Japan · JPNational Center for Tumor Diseases · DERoyal North Shore Hospital · AUSir Charles Gairdner Hospital · AUThe University of Queensland · AUThe University of Texas MD Anderson Cancer Center · USUniversité de Bordeaux · FRUniversité Grenoble Alpes · FRUniversity Hospital Schleswig-Holstein · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCemiplimab (Libtayo

methodsIn this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review.

resultsSixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0-39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n

conclusionsExtended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit-risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.

Indexed as

Carcinoma, Squamous CellSkin NeoplasmsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedcemiplimabclinical trials, phase II as topicimmune checkpoint inhibitorsimmunotherapyprogrammed cell death 1 receptor

Identifiers

PMID38471711
PMCPMC10936461
OpenAlexW4392710900

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.