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PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma
Michael R Migden1, Danny Rischin1, Chrysalyne D Schmults1
1From the Departments of Dermatology and Head and Neck Surgery, University of Texas MD Anderson Cancer Center, Houston (M.R.M.), and South Texas Accelerated Research Therapeutics (START), San Antonio (K.P.P.) - both in Texas; the Department of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, VIC (D.R., A.A.T.), the Department of Medical Oncology, Royal North Shore Hospital, St. Leonards, VIC (A.G.), the Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA (A.M.L.), and Royal Brisbane and Women's Hospital and University of Queensland, Brisbane (B.G.M.H.) - all in Australia; the Department of Dermatology, Brigham and Women's Hospital (C.D.S.), the Department of Dermatology, Harvard Medical School (C.D.S.), and the Department of Medical Oncology, Dana-Farber Cancer Institute (G.R.) - all in Boston; Schleswig-Holstein University Hospital, Kiel (A.H.), and University Hospital Essen, Essen and German Cancer Consortium, Essen (D.S.) - both in Germany; University of Colorado Denver, School of Medicine, Aurora (K.D.L.); the Departments of Head and Neck-Endocrine Oncology (C.H.C.) and Cutaneous Oncology (N.I.K.), H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; the Division of Medical Oncology, Department of Medicine, Washington University School of Medicine, St. Louis (L.H.-A.); the Department of Dermatology, Stanford University School of Medicine, Redwood City (A.L.S.C.), and the Division of Dermatology, City of Hope, Duarte (B.M.) - both in California; the Department of Medicine, Head and Neck Medical Oncology, Memorial Sloan Kettering Cancer Center, New York (L.A.D.), and Regeneron Pharmaceuticals, Tarrytown (F.S., M.M., K.M., G.D.Y., I.L., M.G.F.) - both in New York; Regeneron Pharmaceuticals, Basking Ridge, NJ (B.G., S.L., J.L., J.B., E.S.); University of Arizona Cancer Center, Tucson (H.M.B.), and Banner MD Anderson Cancer (J.H.) and the Department of Medical Oncology, Banner MD Anderson Cancer Center (J.N.), Gilbert - all in Arizona; Medical Oncology Department, Vall D'Hebron University Hospital (I.B.), and Institut Català D'Oncologia, Oncobell Program (IDIBELL), L'Hospitalet de Llobregat (M.G.-M.), Barcelona, and START Madrid-FJD, Hospital Fundación Jiménez Díaz, Madrid (V.M.) - all in Spain; Sarah Cannon Research Institute, Nashville (M.L.J.); and the Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta (T.K.O.).
Cemiplimab, an immune checkpoint inhibitor, shows significant response rates in patients with advanced cutaneous squamous-cell carcinoma. This therapy offers a new treatment option for this difficult-to-treat cancer.
Area of Science:
- Oncology
- Immunotherapy
Background:
- Advanced cutaneous squamous-cell carcinoma lacks approved systemic therapies.
- High tumor mutation burden suggests potential for immune therapy in this cancer.
- Cemiplimab demonstrated promising responses in early-phase studies.
Purpose of the Study:
- To evaluate the efficacy and safety of cemiplimab in patients with advanced cutaneous squamous-cell carcinoma.
- To report results from phase 1 expansion cohorts and a pivotal phase 2 study.
Main Methods:
- Patients received intravenous cemiplimab (3 mg/kg) every 2 weeks.
- Response was assessed every 8 weeks by independent central review.
- Phase 2 study focused on response rate in metastatic disease.
Main Results:
- Response observed in 50% of phase 1 patients and 47% of phase 2 metastatic patients.
- Median follow-up was 7.9 months in the phase 2 metastatic cohort.
- Durable responses were noted, with 57% exceeding 6 months and 82% ongoing at data cutoff. Common adverse events included diarrhea, fatigue, and rash.
Conclusions:
- Cemiplimab is an effective treatment for advanced cutaneous squamous-cell carcinoma, inducing responses in about half of patients.
- Adverse events were consistent with those typically seen with immune checkpoint inhibitors.
- Cemiplimab represents a potential new systemic therapy for advanced cutaneous squamous-cell carcinoma.
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