High response rate with extended dosing of cemiplimab in advanced cutaneous squamous cell carcinoma

Rischin, D; Hughes, BGM; Basset-S&#233;guin, N; Schadendorf, D; Bowyer, S; Trabelsi Messai, S; Meier, F; Eigentler, TK; Casado Echarren, V; Stein, B; Beylot-Barry, M; Dalac, S; Dr&#233;no, B; Migden, MR; Hauschild, A; Schmults, CD; Lim, AM; Yoo, SY; Paccaly, AJ; Papachristos, A; Nguyen, JH; Okoye, E; Seebach, F; Booth, J; Lowy, I; Fury, MG; Guminski, A

Author(s): Rischin, D; Hughes, BGM; Basset-Séguin, N; Schadendorf, D; Bowyer, S; Trabelsi Messai, S; Meier, F; Eigentler, TK; Casado Echarren, V; Stein, B; Beylot-Barry, M; Dalac, S; Dréno, B; Migden, MR; Hauschild, A; Schmults, CD; Lim, AM; Yoo, SY; Paccaly, AJ; Papachristos, A; Nguyen, JH; Okoye, E; Seebach, F; Booth, J; Lowy, I; Fury, MG; Guminski, A;
Details: Publication Year 2024-03-11,Volume 12,Issue #3,Page e008325
Journal Title: Journal for ImmunoTherapy of Cancer
Publication Type: Research article
Abstract: BACKGROUND: Cemiplimab (Libtayo(®)), a human monoclonal immunoglobulin G4 antibody to the programmed cell death-1 receptor, is approved for the treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC), who are not candidates for curative surgery or curative radiation, using an every-3-weeks (Q3W) dosing interval. Pharmacokinetic modeling indicated that C(trough) of extended intravenous dosing of 600 mg every 4 weeks (Q4W) would be comparable to the approved intravenous dosage of 350 mg Q3W. We examined the efficacy, pharmacokinetics, and safety of cemiplimab dosed Q4W. METHODS: In this open-label, phase II trial (ClinicalTrials.gov identifier NCT02760498), the cohort of patients ≥18 years old with advanced CSCC received cemiplimab 600 mg intravenously Q4W for up to 48 weeks. Tumor measurements were recorded every 8 weeks. The primary endpoint was objective response rate by independent central review. RESULTS: Sixty-three patients with advanced CSCC were treated with cemiplimab. The median duration of follow-up was 22.4 months (range: 1.0-39.8). An objective response was observed in 39 patients (62%; 95% CI: 48.8% to 73.9%), with 22% of patients (n=14) achieving complete response and 40% (n=25) achieving partial response. The most common treatment-emergent adverse events were diarrhea, pruritus, and fatigue. CONCLUSIONS: Extended dosing of cemiplimab 600 mg intravenously Q4W exhibited substantial antitumor activity, rapid and durable responses, and an acceptable safety profile in patients with advanced CSCC. These results confirm that cemiplimab is a highly active therapy for advanced CSCC. Additional data would help ascertain the benefit-risk profile for the 600 mg intravenous dosing regimen compared with the approved regimen.
Publisher: BioMed Central
Keywords: Humans; Adolescent; *Carcinoma, Squamous Cell/pathology; *Skin Neoplasms/pathology; Antibodies, Monoclonal, Humanized/adverse effects; Antibodies, Monoclonal/adverse effects; clinical trials, phase II as topic; immune checkpoint inhibitors; immunotherapy; programmed cell death 1 receptor
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1136/jitc-2023-008325
Open Access at Publisher's Site: https://doi.org/10.1136/jitc-2023-008325
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2024-04-18 04:53:23

Last Modified: 2024-10-24 03:40:03