Real-world experience with vismodegib and sonidegib in advanced basal cell carcinoma: a multicenter Italian study

Mario Valenti; Sara Di Giulio; Andrea Carugno; Pasquale Frascione; Angelo Valerio Marzano; Santo Raffaele Mercuri; Gianluca Nazzaro; Giulia Spallone; Giovanni Paolino; Marco Ardigò

doi:10.4081/dr.2025.10196

Vismodegib and sonidegib are smoothened (SMO) inhibitors approved for the treatment of advanced basal cell carcinoma (aBCC). This study investigates the real-world experiences and outcomes associated with these therapies across multiple Italian centers. A retrospective, observational, multicenter study was conducted. Medical records of patients with local advanced basal cell carcinoma (laBCC) treated with SMO inhibitors outside of clinical trials from July 2019 to April 2024 were analyzed. A total of 57 patients were included in the study, with 19 (33.3%) receiving vismodegib and 38 (66.7%) receiving sonidegib. Vismodegib demonstrated a complete response (CR) in 31.6% of cases and a partial response (PR) in 26.3%. Sonidegib achieved a CR of 47.4% and a PR of 36.8%. The median treatment duration was 8 months for vismodegib and 12 months for sonidegib. Adverse events were more frequently reported with vismodegib. Treatment interruption due to adverse events occurred in 47.4% of vismodegib recipients and in 13.2% of those receiving sonidegib. The progression of the disease under treatment occurred in 7.9% of cases of patients under sonidegib and in 26.3% of cases under vismodegib.

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*Appendix Authors list

Valentina Benzecry Mancin,¹ Veronica Benzi,² Matteo Bianco,^2,3 Alessandra Bulotta,⁴ Antonio Costanzo,^2,3 Giuseppe Damiano,⁵ Nerina Denaro,⁶ Laura Eibenschutz,⁷ Barbara Merelli,⁸ Giulia Murgia,¹ Alessandra Narcisi,³ Emanuela Passoni,¹ Francesco Piscazzi,^2,3 Vincenzo Russo⁵

¹Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan; ²Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan; ³Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan; ⁴Department of Oncology, IRCCS San Raffaele, Milan; ⁵Unit of Immuno-Biotherapy of Melanoma and Solid Tumors, IRCCS Ospedale San Raffaele, Milan; ⁶Oncology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan; ⁷Oncologic and Preventive Dermatology Unit, IFO-San Gallicano Dermatological Institute IRCCS, Rome; ⁸Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy

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Supporting Agencies

Sun-Pharmaceutical Industries (Europe) B.V.

Valenti, M., Di Giulio, S., Carugno, A., Frascione, P., Marzano, A. V., Mercuri, S. R., Nazzaro, G., Spallone, G., Paolino, G., & Ardigò, M. (2025). Real-world experience with vismodegib and sonidegib in advanced basal cell carcinoma: a multicenter Italian study. Dermatology Reports. https://doi.org/10.4081/dr.2025.10196