Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years

Emily S. Ruiz; Eva Muñoz-Couselo; Henri Montaudié; Miguel Angel Berciano-Guerrero; Maria del Carmen Álamo de la Gala; Julie Charles; Gaëlle Quéreux; Charlée Nardin; Ricardo Yaya Tur; Stéphane Dalle; Marie Beylot-Barry; Rahul Ladwa; Margaret McGrath; Daniel Brungs; Dean Harris; Hong Shue; Andrea Tazbirkova; Samuel Fourie; Daniel R. Malan; James Oliviero; Lauren Neighbours Wilcoxen; W. Garrett Gray; Philip Clingan

doi:10.1016/j.jaad.2025.09.009

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Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years

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Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years

Emily S. Ruiz, Eva Muñoz-Couselo, Henri Montaudié, Miguel Angel Berciano-Guerrero, Maria del Carmen Álamo de la Gala, Julie Charles, Gaëlle Quéreux, Charlée Nardin, Ricardo Yaya Tur, Stéphane Dalle, …

Journal of the American Academy of Dermatology, Vol.94(1), pp.48-56

2026

DOI: https://doi.org/10.1016/j.jaad.2025.09.009

PMID: 41055628

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Abstract

advanced cutaneous squamous cell carcinoma

cosibelimab

immune checkpoint inhibitors

immunotherapy

programmed death-ligand 1

skin cancer

skin neoplasms

Background: Cosibelimab-ipdl, a high-affinity, programmed death-ligand 1—blocking antibody, is approved by the US Food and Drug Administration for treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or radiation. Objective: To report long-term efficacy and safety outcomes from a pivotal study of cosibelimab in mCSCC or laCSCC.Methods: Patients received intravenous cosibelimab 800 mg every 2 weeks (mCSCC and laCSCC cohorts) or 1200 mg every 3 weeks (mCSCC cohort). The primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DOR) and safety. Results: With a median follow-up duration of 29.3 months for the mCSCC cohort (n = 78), ORR was 50.0% (complete response [CR], 12.8%), median DOR was not reached, and estimated 24-month DOR was 72.1%. With a median follow-up duration of 24.1 months for the laCSCC cohort (n = 31), ORR was 54.8% (CR,25.8%), median DOR was not reached, and the estimated 24-month DOR was 80.2%. Immune-related adverse event rate was 27.6%; 3.6% grade 3, no grade $4 events. Limitations: Nonrandomized; limited biomarker analysis. Conclusion: Cosibelimab demonstrated robust and durable ORRs with increasing CR rates in advanced CSCC and low rates of severe immune-related adverse events.

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Title: Efficacy and safety of cosibelimab in advanced cutaneous squamous cell carcinoma: Results from a Pivotal Open-label Study with a median follow-up of ≥2 years
Authors: Emily S. Ruiz - Brigham and Women's Hospital
Eva Muñoz-Couselo - Vall d'Hebron Hospital Universitari
Henri Montaudié - Centre Hospitalier Universitaire de Nice
Miguel Angel Berciano-Guerrero - Instituto de Investigación Biomédica de Málaga
Maria del Carmen Álamo de la Gala - Hospital Universitario Virgen Macarena
Julie Charles - Université Grenoble Alpes
Gaëlle Quéreux - Centre National de la Recherche Scientifique
Charlée Nardin - Centre Hospitalier Universitaire de Besançon
Ricardo Yaya Tur - Fundación Instituto Valenciano de Oncología
Stéphane Dalle - Hospices Civils de Lyon
Marie Beylot-Barry - Hôpital Saint-André
Rahul Ladwa - Greenslopes Private Hospital
Margaret McGrath - Greenslopes Private Hospital
Daniel Brungs - University of Wollongong
Dean Harris - Christchurch Hospital
Hong Shue - University of the Sunshine Coast, Queensland, UniSC Clinical Trials Centre
Andrea Tazbirkova - Pindara Private Hospital (Australia, Benowa)
Samuel Fourie - ABJ Wilgers Oncology Centre (South Africa)
Daniel R. Malan - Phoenix Pharma (South Africa, Port Elizabeth)
James Oliviero - Checkpoint Therapeutics (Waltham, United States)
Lauren Neighbours Wilcoxen (Corresponding Author) - Checkpoint Therapeutics (Waltham, United States)
W. Garrett Gray - Checkpoint Therapeutics (Waltham, United States)
Philip Clingan - University of Wollongong
Publication details: Journal of the American Academy of Dermatology, Vol.94(1), pp.48-56
Publisher: Elsevier Inc.
Date published: 2026
DOI: 10.1016/j.jaad.2025.09.009
ISSN: 1097-6787
PMID: 41055628
Copyright note: © 2025 The Author(s). Published by Elsevier Inc. on behalf of the American Academy of Dermatology, Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Grant note: Funding for this study was provided by Checkpoint Therapeutics.
Organisation Unit: UniSC Clinical Trials Centre
Language: English
Record Identifier: 991183945802621
Output Type: Journal article

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