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

Research output: Contribution to journal › Research article › Contributed › peer-review

Contributors

  • Brett G M Hughes - , Royal Brisbane and Women's Hospital, University of Queensland (Author)
  • Alexander Guminski - , Royal North Shore Hospital (Author)
  • Samantha Bowyer - , Sir Charles Gairdner Hospital (Author)
  • Michael R Migden - , University of Texas at Austin (Author)
  • Chrysalyne D Schmults - , Brigham and Women's Hospital (Author)
  • Nikhil I Khushalani - , H. Lee Moffitt Cancer Center & Research Institute (Author)
  • Anne Lynn S Chang - , Stanford Medicine (Author)
  • Jean-Jacques Grob - , Aix-Marseille Université (Author)
  • Karl D Lewis - , University of Colorado Denver (Author)
  • George Ansstas - , Washington University St. Louis (Author)
  • Fiona Day - , Calvary Mater Newcastle (Author)
  • Rahul Ladwa - , Royal North Shore Hospital, Princess Alexandra Hospital Brisbane (Author)
  • Brian N Stein - , Icon Cancer Centre (Author)
  • Eva Muñoz Couselo - , Vall d'Hebron University Hospital (Author)
  • Friedegund Meier - , Department of Dermatology, Skin Tumor Center, University Hospital Carl Gustav Carus Dresden (Author)
  • Axel Hauschild - , University Hospital Schleswig-Holstein Campus Kiel (Author)
  • Dirk Schadendorf - , University Hospital Essen, German Cancer Consortium (DKTK) partner site Essen / Düsseldorf, National Center for Tumor Diseases (NCT) West, University of Duisburg-Essen (Author)
  • Nicole Basset-Seguin - , Hôpital Saint-Louis (Author)
  • Badri Modi - , City of Hope Comprehensive Cancer Center - Duarte (Author)
  • Sophie Dalac-Rat - , Dijon University Hospital (CHU Dijon Bourgogne) (Author)
  • Lara A Dunn - , Memorial Sloan-Kettering Cancer Center (Author)
  • Lukas Flatz - , University Hospital Tübingen (Author)
  • Laurent Mortier - , University Hospital of Lille (Author)
  • Sarah Guégan - , Hospital Cochin (Author)
  • Lucie M Heinzerling - , Hospital of the Ludwig-Maximilians-University (LMU) Munich (Author)
  • Janice M Mehnert - , New York University Langone Health (Author)
  • Sabiha Trabelsi - , CHU de Grenoble (Author)
  • Ainara Soria-Rivas - , Hospital Ramon y Cajal (Author)
  • Alexander J Stratigos - , Andreas Sygros Hospital, National and Kapodistrian University of Athens (Author)
  • Claas Ulrich - , Charité – Universitätsmedizin Berlin (Author)
  • Deborah J Wong - , University of California at Los Angeles (Author)
  • Marie Beylot-Barry - , University Hospital of Bordeaux (Author)
  • Paolo Bossi - , Humanitas University , IRCCS Istituto Clinico Humanitas - Rozzano (Milano) (Author)
  • Cristina Bugés Sánchez - , Hospital Germans Trias i Pujol (Author)
  • Sunandana Chandra - , Feinberg School of Medicine (Author)
  • Caroline Robert - , Institut Gustave Roussy (Author)
  • Jeffery S Russell - , University of Utah Hospital (Author)
  • Ann W Silk - , Harvard Medical School (HMS) (Author)
  • Jocelyn Booth - , Regeneron Pharmaceuticals, Inc. (Author)
  • Suk-Young Yoo - , Regeneron Pharmaceuticals, Inc. (Author)
  • Frank Seebach - , Regeneron Pharmaceuticals, Inc. (Author)
  • Israel Lowy - , Regeneron Pharmaceuticals, Inc. (Author)
  • Matthew G Fury - , Regeneron Pharmaceuticals, Inc. (Author)
  • Danny Rischin - , Peter Maccallum Cancer Centre (Author)

Abstract

BACKGROUND: In the phase 2 EMPOWER-CSCC-1 study (NCT02760498), cemiplimab demonstrated antitumor activity against metastatic (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 [IV] every 2 weeks [Groups 1 and 2]) or cemiplimab (350 mg IV [Groups 3 and 6]) every 3 weeks. The primary endpoint 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: Non-randomized study, non-survival primary endpoint.

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.

Details

Original languageEnglish
JournalJournal of the American Academy of Dermatology
Publication statusE-pub ahead of print - 6 Sept 2024
Peer-reviewedYes

External IDs

ORCID /0000-0003-4340-9706/work/169643420
unpaywall 10.1016/j.jaad.2024.06.108
Scopus 85206632118

Keywords