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 BG, 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 (2024)

Publication Type: Journal article

Publication year: 2024

Journal

DOI: 10.1016/j.jaad.2024.06.108

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.

Involved external institutions

Washington University in St. Louis United States (USA) (US) Calvary Mater Newcastle Hospital Australia (AU) Royal North Shore Hospital (RNSH) Australia (AU) Vall d'Hebron University Hospital / Hospital Universitari Vall d'Hebron Spain (ES) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Northwestern University United States (USA) (US) Institut Gustave-Roussy France (FR) Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal France (FR) City of Hope Medical Center United States (USA) (US) Université Bourgogne Franche-Comté France (FR) Klinikum der Universität München Germany (DE) New York University (NYU) United States (USA) (US) Centre hospitalier universitaire de Grenoble France (FR) Hospital Universitario Ramón y Cajal Spain (ES) Andreas Sygros Hospital Greece (GR) Regeneron Pharmaceuticals, Inc. United States (USA) (US) Peter MacCallum Cancer Centre Australia (AU) Royal Brisbane and Women's Hospital Australia (AU) Sir Charles Gairdner Hospital Australia (AU) University of Texas MD Anderson Cancer Center United States (USA) (US) Harvard University United States (USA) (US) H. Lee Moffitt Cancer Center & Research Institute United States (USA) (US) Stanford University United States (USA) (US) Memorial Sloan Kettering Cancer Center United States (USA) (US) Universitätsklinikum Tübingen Germany (DE) Centre Hospitalier Régional Universitaire de Lille (CHRU de Lille) France (FR) Hôpital Cochin France (FR) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Essen Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) University of California Los Angeles (UCLA) United States (USA) (US) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux France (FR) Humanitas University Italy (IT) Health Sciences Research Institute of the “Germans Trias i Pujol” Foundation (IGTP) Spain (ES) Huntsman Cancer Institute United States (USA) (US) Aix-Marseille University / Aix-Marseille Université France (FR) University of Colorado Anschutz Medical Campus United States (USA) (US)

How to cite

APA:

Hughes, B.G., Guminski, A., Bowyer, S., Migden, M.R., Schmults, C.D., Khushalani, N.I.,... Rischin, D. (2024). 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. Journal of the American Academy of Dermatology. https://doi.org/10.1016/j.jaad.2024.06.108

MLA:

Hughes, Brett G.M., et al. "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." Journal of the American Academy of Dermatology (2024).

BibTeX: Download