The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck - Two case reports

Sep 24, 2026

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Non-melanoma skin cancers, including basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), most often arise in the head and neck, where locoregional therapy is typical but systemic options are needed for advanced synchronous disease not amenable to local treatment. This case report presents two elderly patients with synBCC/cSCC treated with full-dose cemiplimab plus sonidegib, achieving remarkable clinical benefit and long-term responses without major adverse events. The findings highlight a potential feasible systemic strategy pending further exploration.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages7

Reading Time18 min

AccessFree to download

Introduction

Background on non-melanoma skin cancers

Risk factors and epidemiology

Case report summary

Combined full-dose cemiplimab and sonidegib therapy

Clinical outcomes and safety signals

Discussion and outlook

Need for evidence and future exploration

TYPE Case Report PUBLISHED 28 February 2023 DOI 10.3389/fonc.2023.1111146 OPEN ACCESS EDITED BY Chandra K. Singh, University of Wisconsin-Madison, United States REVIEWED BY Katja Harbst, Lund University, Sweden Sandeep Kumar, Augusta University, United States *CORRESPONDENCE Elena Colombo elena. colombo@istitutotumori. mi. it SPECIALTY SECTION This article was submitted to Skin Cancer, a section of the journal Frontiers in Oncology RECEIVED 29 November 2022 ACCEPTED 10 February 2023 PUBLISHED 28 February 2023 CITATION Colombo E, Gurizzan C, Ottini A, Caspani F, Bergamini C, Locati LD, Marchiselli C, Alberti A, Lorini L, Licitra LF, Bossi P and Resteghini C (2023) The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck: Two case reports. Front. Oncol. 13:1111146 . doi: 10.3389/fonc.2023.1111146 COPYRIGHT © 2023 Colombo, Gurizzan, Ottini, Caspani, Bergamini, Locati, Marchiselli, Alberti, Lorini, Licitra, Bossi and Resteghini. This is an openaccess article distributed under the terms of the Creative Commons Attribution License (CC BY) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. The association of cemiplimab plus sonidegib for synchronous cutaneous squamous cell carcinoma and basal cell carcinoma of the head and neck: Two case reports Elena Colombo 1*, Cristina Gurizzan 2, Arianna Ottini 1, Francesca Caspani 1, Cristiana Bergamini 1, Laura D. Locati 1, Chiara Marchiselli 2, Andrea Alberti 2, Luigi Lorini 2, Lisa F. Licitra 1,3, Paolo Bossi 2,4 and Carlo Resteghini 1 1 Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, 2 Division of Medical Oncology, Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, ASST Spedali Civili, Brescia, Italy, 3 Department of Oncology and Hematology , University of Milan, Milan, Italy, 4 Department of Oncology and Hematology , University of Brescia, Brescia, Italy Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most frequent cancers in humans, with cumulative ultraviolet radiation exposure, aging, and immunodepression as the main risk factors. In most cases, these malignancies arise in the head and neck area, and they can be treated with locoregional therapies. A minority of cases require systemic therapy. Currently, Sonic Hedgehog inhibitors (i.e., vismodegib and sonidegib) have been approved for advanced BCC, while the PD-1 checkpoint inhibitor cemiplimab has been approved as a ﬁrst-line treatment for cSCC and as a second-line treatment for BCC. Nevertheless, there is a clinical need for an effective and safe systemic therapies for advanced synchronous (syn) BCC/cSCC not amenable to local treatments. International guidelines do not provide speciﬁc recommendations for patients affected by this condition, and no case reports on the full-dose association of these medications have been previously reported. Here, we present the cases of two elderly patients affected by synBCC/cSCC of the head and neck, who received combined therapy with cemiplimab and sonidegib at full dose and standard schedule, achieving remarkable clinical beneﬁt and long-term responses, without major adverse events. The instance of a feasible treatment for patients with advanced synBCC/cSCC will become increasingly frequent with the advancement of life expectancy in the global population, and the synergistic activity of targeted therapies and immunotherapy—administered either in association or sequentially—deserves to be further explored. KEYWORDS cutaneous squamous ce

FAQs

What clinical problem does the article address?

It addresses the need for effective and safe systemic therapy for advanced synchronous BCC/cSCC of the head and neck when patients are not suitable for local treatments and guidelines offer no specific recommendations.

How were cemiplimab and sonidegib used in the reported cases?

Two elderly patients received combined therapy with cemiplimab and sonidegib at full dose and on the standard schedule.

What outcomes and adverse events were reported?

The patients achieved remarkable clinical benefit with long-term responses, without major adverse events.

Sep 24, 2026

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