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

Brett G.M. Hughes*, Alexander Guminski, Samantha Bowyer, Michael R. Migden, Chrysalyne D. Schmults, Nikhil I. Khushalani, Anne Lynn S. Chang, Jean Jacques Grob, Karl D. Lewis, George Ansstas, Fiona Day, Rahul Ladwa, Brian N. Stein, Eva Muñoz Couselo, Friedegund Meier, Axel Hauschild, Dirk Schadendorf, Nicole Basset-Seguin, Badri Modi, Sophie Dalac-RatLara A. Dunn, Lukas Flatz, Laurent Mortier, Sarah Guégan, Lucie M. Heinzerling, Janice M. Mehnert, Sabiha Trabelsi, Ainara Soria-Rivas, Alexander J. Stratigos, Claas Ulrich, Deborah J. Wong, Marie Beylot-Barry, Paolo Bossi, Cristina Bugés Sánchez, Sunandana Chandra, Caroline Robert, Jeffery S. Russell, Ann W. Silk, Jocelyn Booth, Suk Young Yoo, Frank Seebach, Israel Lowy, Matthew G. Fury, Danny Rischin

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)68-77
Number of pages10
JournalJournal of the American Academy of Dermatology
Volume92
Issue number1
DOIs
StatePublished - Jan 2025

Funding

Funding sources: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi.

Keywords

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies
  • Antibodies, Monoclonal, Humanized / pharmacology
  • Antibodies, Monoclonal, Humanized / therapeutic use
  • Carcinoma
  • Carcinoma, Squamous Cell / pathology
  • Female
  • Follow-Up Studies
  • Humanized
  • Humans
  • Male
  • Middle Aged
  • Monoclonal
  • Skin Neoplasms / drug therapy
  • Skin Neoplasms / pathology
  • Squamous Cell / drug therapy
  • Treatment Outcome
  • advanced cutaneous squamous cell carcinoma
  • cemiplimab
  • cemiplimab
  • clinical trials
  • fixed dose
  • immunotherapy
  • skin cancer
  • skin neoplasms

ASJC Scopus subject areas

  • Dermatology

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