A phase 2 open-label study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (EMPOWER-CSCC-1): Final long-term analysis of groups 1, 2, and 3, and primary analysis of fixed-dose treatment group 6

Hughes, BGM; Guminski, A; Bowyer, S; Migden, MR; Schmults, CD; Khushalani, NI; Chang, ALS; Grob, JJ; Lewis, KD; Ansstas, G; Day, F; Ladwa, R; Stein, BN; Mu&#241;oz Couselo, E; Meier, F; Hauschild, A; Schadendorf, D; Basset-Seguin, N; Modi, B; Dalac-Rat, S; Dunn, LA; Flatz, L; Mortier, L; Gu&#233;gan, S; Heinzerling, LM; Mehnert, JM; Trabelsi, S; Soria-Rivas, A; Stratigos, AJ; Ulrich, C; Wong, DJ; Beylot-Barry, M; Bossi, P; Bug&#233;s S&#225;nchez, C; Chandra, S; Robert, C; Russell, JS; Silk, AW; Booth, J; Yoo, SY; Seebach, F; Lowy, I; Fury, MG; Rischin, D

Author(s): Hughes, BGM; Guminski, A; Bowyer, S; Migden, MR; Schmults, CD; Khushalani, NI; Chang, ALS; Grob, JJ; Lewis, KD; Ansstas, G; Day, F; Ladwa, R; Stein, BN; Muñoz Couselo, E; Meier, F; Hauschild, A; Schadendorf, D; Basset-Seguin, N; Modi, B; Dalac-Rat, S; Dunn, LA; Flatz, L; Mortier, L; Guégan, S; Heinzerling, LM; Mehnert, JM; Trabelsi, S; Soria-Rivas, A; Stratigos, AJ; Ulrich, C; Wong, DJ; Beylot-Barry, M; Bossi, P; Bugés Sánchez, C; Chandra, S; Robert, C; Russell, JS; Silk, AW; Booth, J; Yoo, SY; Seebach, F; Lowy, I; Fury, MG; Rischin, D;
Details: Publication Year 2025-01,Volume 92,Issue #1,Page 68-77
Journal Title: Journal of the American Academy of Dermatology
Publication Type: Research article
Abstract: BACKGROUND: In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC). OBJECTIVES: To report final analysis of weight-based cemiplimab in mCSCC and laCSCC (groups 1 and 2), fixed-dose cemiplimab in mCSCC (group 3), and primary analysis of fixed-dose cemiplimab in mCSCC/laCSCC (group 6). METHODS: Patients received cemiplimab (3 mg/kg intravenously every 2 weeks [groups 1 and 2]) or cemiplimab (350 mg intravenously [groups 3 and 6]) every 3 weeks. The primary end point was objective response rate (ORR). Duration of response (DOR) and progression-free survival (PFS) are presented per protocol, according to post-hoc sensitivity analyses that only include the period of protocol-mandated imaging assessments. RESULTS: At 42.5 months, ORR for groups 1-3 (n = 193) was 47.2%, estimated 12-month DOR was 88.3%, and median PFS was 26.0 months. At 8.7 months, ORR for group 6 (n = 165 patients) was 44.8%; median DOR and median PFS were not reached. Serious treatment-emergent adverse event rates (grade ≥3) were groups 1-3: 31.1% and group 6: 34.5%. LIMITATIONS: Nonrandomized study, nonsurvival primary end point. CONCLUSION: EMPOWER-CSCC-1 provides the largest prospective data on long-term efficacy and safety for anti-programmed cell death-1 therapy in advanced CSCC.
Publisher: Elsevier
Keywords: Humans; *Skin Neoplasms/drug therapy/pathology; *Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects; Male; *Carcinoma, Squamous Cell/drug therapy/pathology; Female; Aged; Middle Aged; *Antineoplastic Agents, Immunological/administration & dosage/therapeutic; use/adverse effects; Aged, 80 and over; Progression-Free Survival; Adult; Drug Administration Schedule; Antibodies; Antibodies, Monoclonal, Humanized / pharmacology; Antibodies, Monoclonal, Humanized / therapeutic use; Carcinoma; Carcinoma, Squamous Cell / pathology; Follow-Up Studies; Humanized; Monoclonal; Skin Neoplasms / drug therapy; Skin Neoplasms / pathology; Squamous Cell / drug therapy; Treatment Outcome; advanced cutaneous squamous cell carcinoma; cemiplimab; clinical trials; fixed dose; immunotherapy; skin cancer; skin neoplasms
Department(s): Medical Oncology
Publisher's Version: https://doi.org/10.1016/j.jaad.2024.06.108
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2025-01-21 12:58:09

Last Modified: 2025-01-21 12:58:21