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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 - 18/12/24

Doi : 10.1016/j.jaad.2024.06.108 
Brett G.M. Hughes, MBBS a, b, , Alexander Guminski, MD, PhD c, Samantha Bowyer, MBBCh d, Michael R. Migden, MD e, Chrysalyne D. Schmults, MD f, Nikhil I. Khushalani, MD g, Anne Lynn S. Chang, MD h, Jean-Jacques Grob, MD, PhD i, Karl D. Lewis, MD j, George Ansstas, MD k, Fiona Day, MBBS, PhD l, Rahul Ladwa, MBChB, MPhil c, m, Brian N. Stein, MBBS n, Eva Muñoz Couselo, MD, PhD o, Friedegund Meier, MD p, q, Axel Hauschild, MD r, Dirk Schadendorf, MD s, t, Nicole Basset-Seguin, MD, PhD u, Badri Modi, MD v, Sophie Dalac-Rat, MD w, Lara A. Dunn, MD x, Lukas Flatz, MD y, Laurent Mortier, MD, PhD z, Sarah Guégan, MD, PhD aa, Lucie M. Heinzerling, MD, MPH ab, ac, Janice M. Mehnert, MD ad, Sabiha Trabelsi, MD ae, Ainara Soria-Rivas, MD, PhD af, Alexander J. Stratigos, MD, PhD ag, ah, Claas Ulrich, MD ai, Deborah J. Wong, MD, PhD aj, Marie Beylot-Barry, MD, PhD ak, Paolo Bossi, MD al, am, Cristina Bugés Sánchez, MD, PhD an, ao, Sunandana Chandra, MD ap, Caroline Robert, MD, PhD aq, Jeffery S. Russell, MD, PhD ar, Ann W. Silk, MD, MS as, Jocelyn Booth, MBA at, Suk-Young Yoo, PhD at, Frank Seebach, MD at, Israel Lowy, MD, PhD at, Matthew G. Fury, MD, PhD at, Danny Rischin, MD au
a Department of Cancer Care Services, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia 
b Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia 
c Department of Medical Oncology, Royal North Shore Hospital, St Leonards, New South Wales, Australia 
d Department of Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia 
e Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston, Texas 
f Department of Dermatology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts 
g Department of Cutaneous Oncology, Moffitt Cancer Center, Tampa, Florida 
h Department of Dermatology, Stanford University School of Medicine, Redwood City, California 
i Aix Marseille University, Hôpital de la Timone, Marseille, France 
j University of Colorado Denver Cancer Center, Aurora, Colorado 
k Department of Surgical Oncology, Washington University School of Medicine, St Louis, Missouri 
l Department of Medical Oncology, Calvary Mater Newcastle, Newcastle, New South Wales, Australia 
m Princess Alexandra Hospital, Woolloongabba, Queensland, Australia 
n Adelaide Cancer Centre, Adelaide, South Australia, Australia 
o Department of Medical Oncology, Melanoma and Other Skin Tumors Unit, Vall d'Hebron University Hospital, Barcelona, Spain 
p Department of Dermatology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany 
q Skin Cancer Center at the University Cancer Centre and National Center for Tumor Diseases, Dresden, Germany 
r Department of Dermatology, University Hospital (UKSH), Kiel, Germany 
s Department of Dermatology, University Hospital of Essen, Essen, Germany 
t German Cancer Consortium, Partner Site Essen, NCT-West, Campus Essen and University Alliance Ruhr, Research Center One Health, University Duisburg-Essen, Essen, Germany 
u Hôpital Saint-Louis, Paris, France 
v Division of Dermatology, Department of Surgery, City of Hope, Duarte, California 
w Hospital Center University Dijon Bourgogne, Dijon, France 
x David H. Koch Center for Cancer Care, Memorial Sloan Kettering Cancer Center, New York, New York 
y University Hospital Tübingen, Tübingen, Germany 
z Centre Hospitalier Régional Universitaire de Lille (CHRU), Lille, France 
aa Department of Dermatology, Hôpital Cochin, Paris, France 
ab Department of Dermatology, LMU University Hospital Munich, Munich, Germany 
ac Department of Dermatology, University Hospital Erlangen, Erlangen, Germany 
ad Melanoma and Cutaneous Medical Oncology, Perlmutter Cancer Center, NY University, Langone Health, New York, New York 
ae CHU de Grenoble - Hôpital A Michallon, Grenoble, France 
af Ramón y Cajal University Hospital, Spanish Society of Medical Oncology (SEOM), Madrid, Spain 
ag First Department of Dermatology-Venereology, Andreas Sygros Hospital, Athens, Greece 
ah National and Kapodistrian University of Athens Medical School, Athens, Greece 
ai Charite-Universitatsmedizin Berlin, Berlin, Germany 
aj UCLA Department of Medicine, Los Angeles, California 
ak Department of Dermatology, University Hospital of Bordeaux, Bordeaux, France 
al Department of Biomedical Sciences, Humanitas University, Milan, Italy 
am IRCCS Humanitas Research Hospital, Milan, Italy 
an Department of Medical Oncology, Skin Tumors Unit, Catalan Institute of Oncology, Germans Trias i Pujol University Hospital, Barcelona, Spain 
ao Badalona-Applied Research Group in Oncology (B-ARGO), Badalona, Barcelona, Spain 
ap Division of Hematology Oncology, Northwestern University Feinberg School of Medicine, Chicago, Illinois 
aq Gustave Roussy Cancer Center, Villejuif, France 
ar Head and Neck/Cutaneous Medical Oncology, Huntsman Cancer Institute, Salt Lake City, Utah 
as Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts 
at Regeneron Pharmaceuticals, Inc., Tarrytown, New York 
au Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia 

Correspondence to: Brett G.M. Hughes, MBBS, Cancer Care Services, Royal Brisbane and Women’s Hospital, Butterfield St, Herston, Brisbane, Queensland, 4029, Australia.Cancer Care ServicesRoyal Brisbane and Women’s HospitalButterfield St, HerstonBrisbaneQueensland4029Australia

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.

Le texte complet de cet article est disponible en PDF.

Key words : advanced cutaneous squamous cell carcinoma, cemiplimab, clinical trials, fixed dose, immunotherapy, skin cancer, skin neoplasms

Abbreviations used : AE, CI, CR, CSCC, DOR, ICR, INV, irTEAE, IV, laCSCC, mCSCC, NE, NR, ORR, OS, PD-1, PD-L1, PFS, Q3W, TEAE

MeSH terms : Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized / pharmacology, Antibodies, Monoclonal, Humanized / therapeutic use, Carcinoma, Squamous Cell / drug therapy, Carcinoma, Squamous Cell / pathology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Skin Neoplasms / drug therapy, Skin Neoplasms / pathology, Treatment Outcome

Substances : Antibodies, Monoclonal, Humanized, cemiplimab


Plan


 Funding sources: This study was funded by Regeneron Pharmaceuticals, Inc., and Sanofi.
 Patient consent: All patients provided written informed consent prior to enrollment.
 IRB approval status: The study protocol and all amendments were approved by institutional review boards/ethics committee at each participating study site.


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