title: Pembrolizumab: Role of Modeling and Simulation in Bringing a Novel Immunotherapy to Patients With Melanoma.
abstract: Recently, immunotherapy has yielded promising results in several cancer types. Contrary to the established classical chemotherapy-dosing paradigm, a maximum tolerated dose approach does not always produce better clinical outcomes for novel targeted therapies, as their efficacy is frequently robust at pharmacologically active doses below the maximum tolerated dose. Integrated safety and efficacy assessments are needed to inform clinical dose and trial design, and to support an early identification of potentially safe and efficacious combination treatments.
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.|Quantitative Solutions, a Certara company, Oss, The Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: de Greef
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.|PD-Value, Houten, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Elassaiss-Schaap
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: M
authors.initials: M
authors.lastname: Chatterjee
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: D C
authors.initials: DC
authors.lastname: Turner
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: M
authors.initials: M
authors.lastname: Ahamadi
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: M
authors.initials: M
authors.lastname: Forman
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: D
authors.initials: D
authors.lastname: Cutler
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: D P
authors.initials: DP
authors.lastname: de Alwis
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: A
authors.initials: A
authors.lastname: Kondic
authors.affiliation: Merck & Co., Inc, Kenilworth, New Jersey, USA.
authors.forename: J
authors.initials: J
authors.lastname: Stone
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D017321:Clinical Trials, Phase I as Topic / Q000706:statistics & numerical data; D003198:Computer Simulation / Q000639:trends*; D006801:Humans; D007167:Immunotherapy / Q000379:methods / Q000639:trends*; D008545:Melanoma / Q000175:diagnosis / Q000188:drug therapy*; D008954:Models, Biological; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D012878:Skin Neoplasms / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; C582435:pembrolizumab