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dc.contributor.authorOgungbenro, K
dc.contributor.authorPatel, Alkesh
dc.contributor.authorDuncombe, Robert
dc.contributor.authorNuttall, R
dc.contributor.authorClark, James
dc.contributor.authorLorigan, Paul C
dc.date.accessioned2017-10-23T19:48:51Z
dc.date.available2017-10-23T19:48:51Z
dc.date.issued2017-09-15
dc.identifier.citationDose rationalization of pembrolizumab and nivolumab using pharmacokinetic modeling and simulation and cost analysis. 2017, Clin Pharmacol Theren
dc.identifier.issn1532-6535
dc.identifier.pmid28913853
dc.identifier.doi10.1002/cpt.875
dc.identifier.urihttp://hdl.handle.net/10541/620622
dc.description.abstractPembrolizumab and nivolumab are highly selective anti-programmed cell death 1 (PD-1) antibodies approved for the treatment of advanced malignancies. Variable exposure and significant wastage have been associated with body size dosing of monoclonal antibodies (mAbs). The following dosing strategies were evaluated using simulations: body weight, dose banding, fixed dose, and pharmacokinetic (PK)-based methods. The relative cost to body weight dosing for band, fixed 150 mg and 200 mg, and PK-derived strategies were -15%, -25%, + 7%, and -16% for pembrolizumab and -8%, -6%, and -10% for band, fixed, and PK-derived strategies for nivolumab, respectively. Relative to mg/kg doses, the median exposures were -1.0%, -4.6%, + 27.1%, and +3.0% for band, fixed 150 mg, fixed 200 mg, and PK-derived strategies, respectively, for pembrolizumab and -3.1%, + 1.9%, and +1.4% for band, fixed 240 mg, and PK-derived strategies, respectively, for nivolumab. Significant wastage can be reduced by alternative dosing strategies without compromising exposure and efficacy.
dc.language.isoenen
dc.rightsArchived with thanks to Clinical pharmacology and therapeuticsen
dc.titleDose rationalization of pembrolizumab and nivolumab using pharmacokinetic modeling and simulation and cost analysis.en
dc.typeArticleen
dc.contributor.departmentCentre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchesteren
dc.identifier.journalClinical Pharmacology and Therapeuticsen
html.description.abstractPembrolizumab and nivolumab are highly selective anti-programmed cell death 1 (PD-1) antibodies approved for the treatment of advanced malignancies. Variable exposure and significant wastage have been associated with body size dosing of monoclonal antibodies (mAbs). The following dosing strategies were evaluated using simulations: body weight, dose banding, fixed dose, and pharmacokinetic (PK)-based methods. The relative cost to body weight dosing for band, fixed 150 mg and 200 mg, and PK-derived strategies were -15%, -25%, + 7%, and -16% for pembrolizumab and -8%, -6%, and -10% for band, fixed, and PK-derived strategies for nivolumab, respectively. Relative to mg/kg doses, the median exposures were -1.0%, -4.6%, + 27.1%, and +3.0% for band, fixed 150 mg, fixed 200 mg, and PK-derived strategies, respectively, for pembrolizumab and -3.1%, + 1.9%, and +1.4% for band, fixed 240 mg, and PK-derived strategies, respectively, for nivolumab. Significant wastage can be reduced by alternative dosing strategies without compromising exposure and efficacy.


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