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| Home > Publications database > 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 2 DeCOG trial. |
| Home > Publications database > 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 2 DeCOG trial. |
| Journal Article | DKFZ-2025-01553 |
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2025
Oxford University Press
Oxford
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Please use a persistent id in citations: doi:10.1093/bjd/ljaf303
Abstract: In cutaneous squamous cell carcinoma (cSCC), PD-1 and 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.This multicentre phase-2 trial enrolled patients with advanced cSCC (prior systemic therapy allowed) to receive the PD-L1 inhibitor avelumab (10 mg/kg q2w) plus the EGFR inhibitor cetuximab (500 mg/m2 q2w) for up to 1 year. The primary endpoint was objective response (OR). Predefined subgroups were line of therapy and localisation of the primary tumor (perianogenital/other locations).Of 52 enrolled patients, 49 received at least 1 dose of treatment. Of these, 20 patients achieved an OR (41%, 95% confidence interval (CI) 27-56, 9 partial/11 complete responses (PRs/CRs)). While treatment-naïve patients (n=35) achieved a higher OR rate (46%, 95% CI 29-63) than those pretreated (29%, 95% CI 8-58), 4/14 pretreated patients experienced an OR, 2 with prior PD-1 inhibition. 5 out of 14 patients with perianogenital cSCC achieved an OR (36%, 95% CI 13-65), including 4 CRs. At a median follow-up of 35 months, the median progression free/overall survival (PFS/OS) was 8.4/23.1 months. Grade 1-2 treatment related adverse events (TRAEs) were common, while grade 3 or higher events occurred in only 10 patients (20%) and 7 patients 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.
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