Immunogenicity of pembrolizumab in patients with advanced tumors

Journal for Immunotherapy of Cancer
Marianne J H van VugtT Freshwater

Abstract

Pembrolizumab is a potent, humanized, monoclonal anti-programmed death 1 antibody that has demonstrated effective antitumor activity and acceptable safety in multiple tumor types. Therapeutic biologics can result in the development of antidrug antibodies (ADAs), which may alter drug clearance and neutralize target binding, potentially reducing drug efficacy; such immunogenicity may also result in infusion reactions, anaphylaxis, and immune complex disorders. Pembrolizumab immunogenicity and its impact on exposure, safety, and efficacy was assessed in this study. Pembrolizumab immunogenicity was assessed in 3655 patients with advanced or metastatic cancer treated in 12 clinical studies. Patients with melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, colorectal cancer, urothelial cancer, and Hodgkin lymphoma were treated with pembrolizumab at 2 mg/kg every 3 weeks, 10 mg/kg every 2 weeks, 10 mg/kg every 3 weeks, or 200 mg every 3 weeks. An additional study involving 496 patients with stage III melanoma treated with 200 mg adjuvant pembrolizumab every 3 weeks after complete resection was analyzed separately. Of 3655 patients, 2000 were evaluable for immunogenicity analysis, 36 (1.8%) were treatment-emerg...Continue Reading

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Citations

Jun 18, 2020·Allergo Journal : interdisziplinäre Zeitschrift für Allergologie und Umweltmedizin : Organ der Deutschen Gesellschaft für Allergie- und Immunitätsforschung·Askin GülsenUta Jappe
Jun 20, 2020·Cancer Immunology, Immunotherapy : CII·Barry D HockMargaret J Currie
Jan 16, 2021·Drug Discovery Today·Sandeep KumarAjay Rana
Mar 12, 2021·Cytometry. Part a : the Journal of the International Society for Analytical Cytology·Fabian JunkerHenry Kao

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NCT02362594

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