Evidence map›Paper›PMID 37848259›Full record

ArticleJournal for immunotherapy of cancer2023

Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma.

Philip Clingan, Rahul Ladwa, Daniel Brungs, Dean Laurence Harris, Margaret McGrath, Susan Arnold, Jermaine Coward, Samuel Fourie, Andriy Kurochkin, Daniel R Malan and 16 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03212404 (A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers), which is not on this map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
–field-weighted citation impact
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.

NCT03212404 phase1active not recruitingnot on this map

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

TypeinterventionalSponsorCheckpoint Therapeutics, Inc.Ran2017 to 2025Enrolled272ConditionsLung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, AdvancedArmsCK-301 (cosibelimab)
3 · Its place in the literature

Who cites it

33 citing papers in PubMed.

  1. Article
  2. Understanding the Therapeutic Potential of PD-1 Agonism in Inflammatory and Autoimmune Disorders.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  3. Advances in Cancer Immunotherapy for Solid Tumors.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Cosibelimab: A Novel Therapeutic for Advanced Cutaneous Squamous Cell Carcinoma.The Journal of clinical and aesthetic dermatology · 2025
    Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. 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

26 authors.

Philip ClinganSouthern Medical Day Care Centre, Wollongong, New South Wales, Australia.
Rahul LadwaPrincess Alexandra Hospital, University of Queensland, Brisbane, Queensland, Australia.
Daniel BrungsSouthern Medical Day Care Centre, Wollongong, New South Wales, Australia.
Dean Laurence HarrisChristchurch Hospital, Christchurch, New Zealand.
Margaret McGrathMedical Oncology, Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, Queensland, Australia.
Susan ArnoldExellentis Clinical Trial Consultants, George, South Africa.
Jermaine CowardICON Cancer Centre, South Brisbane, Queensland, Australia.
Samuel FourieWilgers Oncology Centre, Pretoria, South Africa.
Andriy KurochkinMunicipal Nonprofit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Dispensary, Sumy, Ukraine.
Daniel R MalanPhoenix Pharma, Port Elizabeth, South Africa.
Andrew MantMedical Oncology Unit, Eastern Health, Melbourne, Victoria, Australia.
Vinay SharmaWits Clinical Research Chris Hani Baragwanath Clinical Trial Site, Johannesburg, South Africa.
Hong ShueSunshine Coast Haematology and Oncology Clinic, Buderim, Queensland, Australia.
Andrea TazbirkovaMedical Oncology, Pindara Private Hospital, Gold Coast, Queensland, Australia.
Miguel-Angel Berciano-GuerreroMedical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain.ORCID 0000-0002-5437-5196
Chaiyut CharoentumDepartment of Internal Medicine, Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand.
Stéphane DalleHospices Civils de Lyon - Hopital Lyon Sud, Pierre-Bénite, France.
Arunee DechaphunkulSongklanagarind Hospital, Prince of Songkla University, Songkhla, Thailand.
Oleksandr DudnichenkoKharkiv Medical Academy of Postgraduate Education, Chair of Oncology and Children's Oncology, Clinical base State institution "VT Zaycev Institute of General and Urgent Surgery of National Academy Medical Sciences of Ukraine", Kharkiv, Ukraine.
Piotr KoralewskiSzpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o.o., Oddział Onkologii Klinicznej z Pododdziałem Dziennym, Kraków, Poland.
Iwona LugowskaNarodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział Badań Wczesnych Faz, Warsaw, Poland.
Henri MontaudiéCentre Hospitalier Universitaire de Nice - Hôpital l'Archet, Nice, France.
Eva Muñoz-CouseloHospital Universitario Vall d'Hebron, Passeig de la Vall d'Hebron, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Virote SriuranpongKing Chulalongkorn Memorial Hospital, Bangkok, Thailand.
James OlivieroCheckpoint Therapeutics Inc, Waltham, Massachusetts, USA jfo@checkpointtx.com.ORCID 0009-0009-9857-1189
Jayesh DesaiDepartment of Medical Oncology, Peter MacCallum Cancer Centre; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProgrammed cell death receptor-1 (PD-1)-blocking antibodies are approved to treat metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) cases ineligible for curative surgery or radiation. Notwithstanding, some patients experience inadequate responses or severe immune-related adverse events (AEs), indicating the need for improved therapies. Cosibelimab is a high-affinity programmed cell death-ligand 1 (PD-L1)-blocking antibody that activates innate and adaptive immunity by blocking PD-L1 interaction with PD-1 and B7-1 receptors. It is an unmodified immunoglobulin G1 subtype with a functional Fc domain capable of inducing antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. Here, we present results of the pivotal study of patients with metastatic CSCC from an open-label, multicenter, multiregional, multicohort, phase 1 trial of cosibelimab.

methodsIn this trial, participants with metastatic CSCC received cosibelimab 800 mg intravenously every 2 weeks. Primary endpoint was objective response rate (ORR) by independent central review using Response Evaluation Criteria in Solid Tumors, V.1.1. Secondary endpoints included duration of response (DOR) and safety.

resultsObjective response was observed in 37 of 78 participants (47.4% (95% CI: 36.0% to 59.1%)), with median follow-up of 15.4 months (range: 0.4 to 40.5) as of data cut-off. Median DOR was not reached (range: 1.4+ to 34.1+ months), with response ongoing in 73.0% of participants. Common treatment-emergent AEs (≥15%) were fatigue (26.9%), rash (16.7%), and anemia (15.4%). Eighteen participants (23.1%) experienced immune-related AEs (grade 3: n=2 (2.6%); no grade 4/5). No treatment-related deaths were reported.

conclusionsCosibelimab demonstrated clinically meaningful ORR and DOR and was associated with a manageable safety profile. TRIAL REGISTRATION NUMBER: NCT03212404.

Indexed as

Carcinoma, Squamous CellSkin NeoplasmsAntibodies, MonoclonalB7-H1 AntigenHumansImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorAntibodies, MonoclonalB7-H1 AntigenImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorImmune Checkpoint InhibitorsImmunotherapyProgrammed Cell Death 1 ReceptorSkin Neoplasms

Identifiers

PMID37848259
PMCPMC10582968

What OpenQuestion holds

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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.