Avelumab plus cetuximab in patients with unresectable stage III or IV cutaneous squamous cell carcinoma: clinical activity and safety results from AliCe, a single-arm multicentre phase II DeCOG trial
In cutaneous squamous cell carcinoma (cSCC), programmed cell death protein 1 (PD-1) and epidermal growth factor receptor (EGFR) inhibitors are effective in a considerable proportion of patients. However, there is an unmet medical need for patients with perianogenital cSCC or cSCC refractory to PD-1...
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| Autores principales: | , , , , , , , , , , , , , , , , |
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| Formato: | Article (Journal) |
| Lenguaje: | inglés |
| Publicado: |
November 2025
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| In: |
British journal of dermatology
Year: 2025, Volumen: 193, Número: 5, Pages: 865-875 |
| ISSN: | 1365-2133 |
| DOI: | 10.1093/bjd/ljaf303 |
| Acceso en línea: | Resolving-System, lizenzpflichtig, Volltext: https://doi.org/10.1093/bjd/ljaf303
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| Notas de Autor: | Jürgen C Becker, Anja H Gesierich, Ulrike Leiter, Lisa Zimmer, Jessica C Hassel, Imke von Wasielewski, Mirjana Ziemer, Michael Fluck, Friedegund Meier, Alexandra N Spillner, Bastian Schilling, Thomas K Eigentler, Elisabeth Livingstone, Selma Ugurel, Yenny Angela, Christine Windemuth-Kieselbach, Ralf Gutzmer, on behalf of DeCOG |
| Sumario: | In cutaneous squamous cell carcinoma (cSCC), programmed cell death protein 1 (PD-1) and epidermal growth factor receptor (EGFR) inhibitors are effective in a considerable proportion of patients. However, there is an unmet medical need for patients with perianogenital cSCC or cSCC refractory to PD-1 therapy.To evaluate the combination avelumab (programmed death ligand 1 inhibitor) and cetuximab (EGFR inhibitor) in people with advanced cSCC treated for up to 1 year.This multicentre phase II trial enrolled patients with advanced cSCC (prior systemic therapy allowed) to receive avelumab (10 mg kg-1 Q2W) plus cetuximab (500 mg m-2 Q2W) for up to 1 year. The primary endpoint was objective response. Predefined subgroups were line of therapy and localization of the primary tumour (perianogenital/other locations).Of 52 enrolled patients, 49 received at least 1 treatment dose. Of these patients, 20 achieved an objective response [41%, 95% confidence interval (CI) 27-56; 9 partial responses/11 complete responses (CRs)]. While treatment-naïve patients (n = 35) achieved a higher objective response rate (46%, 95% CI 29-63) than those who were pretreated (29%, 95% CI 8-58), 4 of 14 pretreated patients experienced an objective response, 2 with prior PD-1 inhibition. Five of 14 patients with perianogenital cSCC achieved an objective response (36%, 95% CI 13-65), including 4 CRs. At a median follow-up of 35 months, median progression-free and overall survival were 8.4 and 23.1 months, respectively. Grade 1 and 2 treatment-related adverse events (TRAEs) were common, while grade ≥ 3 events occurred in only 10 patients (20%) and 7 experienced serious TRAEs (14%); 2 discontinued treatment due to drug-related toxicity. Notably, quality of life improved, especially in patients with perianogenital primaries.Avelumab in combination with cetuximab demonstrates encouraging clinical activity in advanced cSCC, including patients with challenging subgroups such as perianogenital primaries or those with disease that has progressed on anti-PD-1 monotherapy. This is especially true when patients are carefully selected for their ability to undergo treatment for at least 12 weeks.Cutaneous squamous cell carcinoma (cSCC) is a type of skin cancer that can be hard to treat. Sometimes, combining different medicines can help. Some drugs work well for many patients, but over time, the cancer can stop responding to these drugs. So, better treatments are needed.This study looked at two drugs, avelumab and cetuximab, used together in people with advanced cSCC. They were treated for up to 1 year. We wanted to see how well this treatment worked.Out of 49 patients who took at least one dose, 20 showed a positive response to the treatment. Patients who had never had treatment before responded better than those who had been treated before. The patients were followed for almost 3 years. On average, the cancer did not get worse for more than 8 months. After treatment, patients lived for almost 2 years.There were some side effects from the treatment. Two patients had to stop because of serious side effects. But overall, patients reported a better quality of life.Our results suggest that this treatment could be a good option for people with advanced cSCC. When patients can handle the treatment, it may also improve how they feel day-to-day. |
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| Notas: | Online veröffentlicht am: 26. Juli 2025 Gesehen am 27.05.2026 |
| Descripción Física: | Online Resource |
| ISSN: | 1365-2133 |
| DOI: | 10.1093/bjd/ljaf303 |