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Publications

Journal Article Ahead of print

PubMed: 42683634 DOI: 10.1111/ddg.70440

Cemiplimab in cutaneous squamous cell carcinoma: a longer follow-up study focusing on the late toxicities.

J Dtsch Dermatol Ges

Authors: Marco Rubatto, Alice Baggi, Roberta Depenni, Michele Guida, Paolo Antonio Ascierto, Paola Queirolo, Ketty Peris, Francesco Spagnolo, Luca Bianchi, Federica De Galitiis, Manuel Zamparini, Ilaria Proietti, Riccardo Marconcini, Andrea Botticelli, Vito Barbieri, Salvatore Alfieri, Maria Concetta Fargnoli, Marcella Occelli, Paolo Fava, Alessio Capacchione, Valentina Comunanza, Paolo Bossi, Pietro Quaglino

Affiliations

  • Candiolo Cancer Institute, FPO - IRCCS, Candiolo, Turin, Italy.
  • Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Italy.
  • Medical Oncology Unit, Department of Medical & Surgical Specialties, Radiological Sciences & Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy.
  • Department of Oncology, Modena University Hospital, Modena, Italy.
  • Rare Tumors and Melanoma Unit, Istituto Tumori "Giovanni Paolo II", Bari, Italy.
  • Medical Oncology Department, Istituto Nazionale Tumori, IRCCS, Fondazione "G. Pascale,", Naples, Italy.
  • Division of Medical Oncology for Melanoma, European Institute of Oncology IRCCS, Milan, Italy.
  • Dermatology, Università Cattolica del Sacro Cuore, Rome, Italy.
  • Dermatologia, Dipartimento Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Medical Oncology 2, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
  • Dermatologic Unit, Department of Systems Medicine, University of Rome Tor Vergata - School of Medicine and Surgery, Rome, Italy.
  • Oncology Department, IDI - Istituto Dermopatico dell'Immacolata - IRCCS, Rome, Italy.
  • Dermatology Unit "Daniele Innocenzi", Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Polo Pontino, Terracina, Italy.
  • Medical Oncology Unit, AOU Pisana, Pisa, Italy.
  • Department of Radiology, Oncology and Human Pathology, Sapienza University of Rome, Rome, Italy.
  • Medical Oncology Unit, Azienda Ospedaliera di Catanzaro Pugliese Ciaccio, Catanzaro, Italy.
  • Medical Oncology Department, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Italy.
  • Department of Clinical Sciences and Applied Biotechnology, University of L'Aquila; San Salvatore Hospital, Coppito, Italy.
  • Department of Medicine, Clinical Oncology and Translational Research, Azienda Ospedaliera Santa Croce and Carle University Teaching Hospital, Cuneo, Italy.
  • Department of Medical Sciences, Section of Dermatology, AOU Città della Salute e della Scienza, University of Turin, Turin, Italy.
  • Department of Oncology, University of Torino, Turin, Italy.

Abstract

BACKGROUND AND OBJECTIVES

Cemiplimab was the first systemic therapy approved for advanced cutaneous squamous cell carcinoma (cSCC).

PATIENTS AND METHODS

We report findings from the Italian early access program cohort, comprising 134 patients treated with cemiplimab, with emphasis on late-onset toxicities and long-term clinical outcomes. Late toxicities were defined as treatment-related adverse events (TRAEs) occurring ≥ 6 months after therapy initiation. Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated.

RESULTS

Median PFS was 9 months. 58 (43.3%) patients experienced progression while 76 (56.7%) maintained a response. Median OS was 21 months (range 0-32), and 67 (50%) patients died. The ORR and DCR were 58.9% and 72.4%, respectively. CR increased from 15% (20 patients) in September 2020 to 19.4% (26 patients) in early 2022. 15 (11.2%) patients had at least one TRAE and 2 of them stopped cemiplimab. Median time to TRAE onset was 12 months (range 6-23); all events resolved after therapy discontinuation, and none of the AEs became chronic.

CONCLUSIONS

With a longer follow-up than that reported in registrational studies and real-world reports, the clinical activity of cemiplimab was confirmed, with a limited incidence of late toxicities. However, some TRAEs may emerge after prolonged treatment.

MeSH

Cells, Follow-Up Studies, Carcinoma, Squamous Cell, Skin Diseases, Therapeutics, Cutaneous Squamous Cell Carcinoma