Jingjin Li

PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

Background No systemic therapies have been approved for the treatment of advanced cutaneous squamous‐cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose‐escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous‐cell carcinoma. Methods We report the results of the phase 1 study of cemiplimab for expansion cohorts of patients with locally advanced or metastatic cutaneous squamous‐cell carcinoma, as well as the results of the pivotal phase 2 study for a cohort of patients with metastatic disease (metastatic‐disease cohort). In both studies, the patients received an intravenous dose of cemiplimab (3 mg per kilogram of body weight) every 2 weeks and were assessed for a response every 8 weeks. In the phase 2 study, the primary end point was the response rate, as assessed by independent central review. Results In the expansion cohorts of the phase 1 study, a response to cemiplimab was observed in 13 of 26 patients (50%; 95% confidence interval [CI], 30 to 70). In the metastatic‐disease cohort of the phase 2 study, a response was observed in 28 of 59 patients (47%; 95% CI, 34 to 61). The median follow‐up was 7.9 months in the metastatic‐disease cohort of the phase 2 study. Among the 28 patients who had a response, the duration of response exceeded 6 months in 57%, and 82% continued to have a response and to receive cemiplimab at the time of data cutoff. Adverse events that occurred in at least 15% of the patients in the metastatic‐disease cohort of the phase 2 study were diarrhea, fatigue, nausea, constipation, and rash; 7% of the patients discontinued treatment because of an adverse event. Conclusions Among patients with advanced cutaneous squamous‐cell carcinoma, cemiplimab induced a response in approximately half the patients and was associated with adverse events that usually occur with immune checkpoint inhibitors. (Funded by Regeneron Pharmaceuticals and Sanofi; ClinicalTrials.gov numbers, NCT02383212 and NCT02760498.)

Cemiplimab (REGN2810), a Fully Human Anti-PD-1 Monoclonal Antibody, for Patients with Unresectable Locally Advanced or Metastatic Cutaneous Squamous Cell Carcinoma: Initial Safety and Efficacy from Expansion Cohorts of Phase 1 Study

Abstract not available. Disclosures:xa0 Study sponsored by Regeneron Pharmaceuticals Inc. and Sanofi. Copyright 2018 SKIN

1151PCemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a phase I study

M.J. Pishvaian, G.J. Weiss, G.S. Falchook, N. Yee, M. Gil-Martin, S. Shahda, V. Moreno, I. Brana, M. Crittenden, S. Formenti, R. Al-Rajabi, K.P. Papadopoulos, E. Stankevich, M. Feng, J. Li, M. Mathias, G. Kroog, I. Lowy, M.G. Fury Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington DC, USA, Department of Internal Medicine, University of Arizona College of Medicine, Phoenix, AZ, USA, Drug Development, Sarah Cannon Research Institute at HealthONE, Denver, CO, USA, Hematology/Oncology, Penn State Cancer Institute, Hershey, PA, USA, Institut Catal a d’Oncologia, L’Hospitalet de Llobregat, Spain, Indiana University School of Medicine, Indiana University Melvin Bren Simon Cancer Center, Indianapolis, IN, USA, START Madrid-FJD, Hospital Fundaci on Jiménez D ıaz, Madrid, Spain, Department of Medical Oncology, Vall D’Hebron Institute of Oncology, Barcelona, Spain, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center and The Oregon Clinic, Portland, OR, USA, Department of Radiation Oncology, Weill Cornell Medicine, New York, NY, USA, Department of Internal Medicine, Division of Hematology/Oncology, University of Kansas Cancer Center, Kansas City, KS, USA, Clinical Research, START, San Antonio, TX, USA, Clinical Sciences, Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA, Biostatistics & Data Management, Regeneron Pharmaceuticals, Inc., Basking Ridge, NJ, USA, Clinical Sciences, Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA