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PK/PD modeling analysis for dosing regimen selection of isatuximab as single agent and in combination therapy in patients with multiple myeloma by Koiwai, Kimiko (author);El‐Cheikh, Raouf (author);Thai, Hoai‐Thu (author);Brillac, Claire (author);Fau, Jean‐Baptiste (author);Veyrat‐Follet, Christine (author);Risse, Marie‐Laure (author);van de Velde, Helgi (author);Semiond, Dorothée (author);Nguyen, Laurent (author) is a Medicine article available to read on EtoBox.

What is PK/PD modeling analysis for dosing regimen selection of isatuximab as single agent and in combination therapy in patients with multiple myeloma about?

## Abstract This analysis describes the pharmacokinetic/pharmacodynamic (PK/PD) modeling framework that supported selection of the isatuximab (anti‐CD38 monoclonal antibody) dosing regimen alongside its early clinical development in patients with relapsed/refractory multiple myeloma (RRMM). The PK/PD mathematical model characterized the variations of patient serum M‐protein concentrations, the primary marker of tumor burden in multiple myeloma (MM). Three separate PK/PD models were built sequentially as data became available from phase I clinical trials. The primary PK/PD analysis was initiated using monotherapy phase I study data (__n__ = 122), followed by analysis of data collected from phase Ib combination studies with lenalidomide and dexamethasone (Rd, __n__ = 40) and then with pomalidomide and dexamethasone (Pd, __n__ = 31). Using the PK/PD model, abnormal “myeloma” protein (M‐protein) profiles under different isatuximab dosing regimens were simulated. Overall, simulations revealed that regimens which included a loading period of four weekly administrations followed by administration every 2 weeks thereafter (QW4‐Q2W), reduced M‐protein levels more than a Q2W regimen without

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Author

Koiwai, Kimiko (author);El‐Cheikh, Raouf (author);Thai, Hoai‐Thu (author);Brillac, Claire (author);Fau, Jean‐Baptiste (author);Veyrat‐Follet, Christine (author);Risse, Marie‐Laure (author);van de Velde, Helgi (author);Semiond, Dorothée (author);Nguyen, Laurent (author)

Publisher

Wiley

Published

2021

Language

EN

Field

Medicine (Physical Sciences)