Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma

Alice Baggi, Pietro Quaglino, Marco Rubatto, Roberta Depenni, Michele Guida, Paolo Antonio Ascierto, Claudia Trojaniello, Paola Queirolo, Maristella Saponara, Ketty Peris, Francesco Spagnolo, Luca Bianchi, Federica De Galitiis, Maria Concetta Potenza, Ilaria Proietti, Riccardo Marconcini, Andrea Botticelli, Vito Barbieri, Pietro Vittorio Barbieri, Lisa LicitraSalvatore Alfieri, Sergio Alfieri, Corrado Ficorella, Alessio Cortellini, Maria Concetta Fargnoli, Teresa Troiani, Luca Tondulli, Paolo Bossi

Research output: Contribution to journalArticle


Background: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. Methods: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. Results: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3–4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. Conclusions: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical trials. We identified some clinical and biochemical factors potentially associated with response to cemiplimab.
Original languageEnglish
Pages (from-to)250-258
Number of pages9
JournalEuropean Journal of Cancer
Publication statusPublished - 2021


  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized
  • Carcinoma, Squamous Cell
  • Cemiplimab
  • Cutaneous squamous cell carcinoma
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Humans
  • Immune Checkpoint Inhibitors
  • Immunotherapy
  • Italy
  • Male
  • Middle Aged
  • Programmed Cell Death 1 Receptor
  • Real world
  • Response Evaluation Criteria in Solid Tumors
  • Retrospective Studies
  • Skin Neoplasms
  • Young Adult


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