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Published VersionCC BY V4.0, Open
Journal article
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
Journal of the American Academy of Dermatology, Vol.94(1), pp.48-56
2026
PMID: 41055628
Abstract
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.
Details
- 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 HospitalEva Muñoz-Couselo - Vall d'Hebron Hospital UniversitariHenri Montaudié - Centre Hospitalier Universitaire de NiceMiguel Angel Berciano-Guerrero - Instituto de Investigación Biomédica de MálagaMaria del Carmen Álamo de la Gala - Hospital Universitario Virgen MacarenaJulie Charles - Université Grenoble AlpesGaëlle Quéreux - Centre National de la Recherche ScientifiqueCharlée Nardin - Centre Hospitalier Universitaire de BesançonRicardo Yaya Tur - Fundación Instituto Valenciano de OncologíaStéphane Dalle - Hospices Civils de LyonMarie Beylot-Barry - Hôpital Saint-AndréRahul Ladwa - Greenslopes Private HospitalMargaret McGrath - Greenslopes Private HospitalDaniel Brungs - University of WollongongDean Harris - Christchurch HospitalHong Shue - University of the Sunshine Coast, Queensland, UniSC Clinical Trials CentreAndrea 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; 0190-9622
- 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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