Cemiplimab for Locally Advanced and Metastatic Cutaneous Squamous-Cell Carcinomas: Real-Life Experience from the French CAREPI Study Group
C. Hober, Lisa Fredeau, Anne Pham‐Ledard, Marouane Boubaya, F. Herms, P. Celérier, F. Aubin, N. Bénéton, Monica Dinulescu, A. Jannic, Nicolás Meyer, Anne-Bénédicte Duval-Modeste, Laure Césaire, Eve‐Marie Neidhardt, E. Archier, Brigitte Dréno, C. Lesage, C. Berthin, N. Kramkimel, Florent Grange, Julie De Quatrebarbes, Pierre‐Emmanuel Stoebner, Nicolas Poulalhon, Jean‐Philippe Arnault, Safia Abed, B. Bonniaud, Sophie Darras, Valentine Heidelberger, S. Devaux, M. Moncourier, L. Misery, Sandrine Mansard, M. Étienne, F. Brunet‐Possenti, C. Jacobzone, Romain Lesbazeilles, F. Skowron, Julia Sanchez, Stéphanie Catala, M. Samimi, Youssef Tazi, Dominique Spaëth, Caroline Gaudy‐Marqueste, Olivier Collard, Raoul Triller, Marc Pracht, Marc‐Emmanuel Dumas, L. Peuvrel, Pierre Combe, O. Lauche, Pierre Guillet, Yves Réguerre, I. Kupfer‐Bessaguet, D. Solub, A. Schoeffler, Christophe Bédane, G. Quéreux, S. Dalac, Laurent Mortier, E. Maubec
Abstract
Although cemiplimab has been approved for locally advanced (la) and metastatic (m) cutaneous squamous-cell carcinomas (CSCCs), its real-life value has not yet been demonstrated. An early-access program enrolled patients with la/mCSCCs to receive cemiplimab. Endpoints were best overall response rate (BOR), progression-free survival (PFS), overall survival (OS), duration of response (DOR) and safety. The 245 patients (mean age 77 years, 73% male, 49% prior systemic treatment, 24% immunocompromised, 27% Eastern Cooperative Oncology Group performance status (PS) ≥ 2) had laCSCCs (35%) or mCSCCs (65%). For the 240 recipients of ≥1 infusion(s), the BOR was 50.4% (complete, 21%; partial, 29%). With median follow-up at 12.6 months, median PFS was 7.9 months, and median OS and DOR were not reached. One-year OS was 73% versus 36%, respectively, for patients with PS < 2 versus ≥ 2. Multivariate analysis retained PS ≥ 2 as being associated during the first 6 months with PFS and OS. Head-and-neck location was associated with longer PFS. Immune status had no impact. Severe treatment-related adverse events occurred in 9% of the patients, including one death from toxic epidermal necrolysis. Cemiplimab real-life safety and efficacy support its use for la/mCSCCs. Patients with PS ≥ 2 benefited less from cemiplimab, but it might represent an option for immunocompromised patients.