Application of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma.
| Title: | Application of a Two-Analyte Integrated Population Pharmacokinetic Model to Evaluate the Impact of Intrinsic and Extrinsic Factors on the Pharmacokinetics of Polatuzumab Vedotin in Patients with Non-Hodgkin Lymphoma. |
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| Authors: | Lu D; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA. lu.dan@gene.com.; Genentech Research and Early Development, 1 DNA Way, MS46-3a, South San Francisco, California, 94080, USA. lu.dan@gene.com.; Lu T; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Shi R; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Gibiansky L; QuantPharm LLC, North Potomac, Maryland, USA.; Agarwal P; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Shemesh CS; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Dere RC; Department of Bioanalytical Sciences, Genentech, Inc, South San Francisco, California, USA.; Ogbu U; Product Development Oncology, Genentech, Inc, South San Francisco, California, USA.; Hirata J; Product Development Oncology, Genentech, Inc, South San Francisco, California, USA.; Chanu P; Department of Clinical Pharmacology, Genentech, Inc/F. Hoffmann-La Roche Ltd, Lyon, France.; Girish S; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Jin JY; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Li C; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA.; Miles D; Department of Clinical Pharmacology, Genentech, Inc, South San Francisco, California, USA. |
| Source: | Pharmaceutical research [Pharm Res] 2020 Dec 01; Vol. 37 (12), pp. 252. Date of Electronic Publication: 2020 Dec 01. |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Kluwer Academic/Plenum Publishers Country of Publication: United States NLM ID: 8406521 Publication Model: Electronic Cited Medium: Internet ISSN: 1573-904X (Electronic) Linking ISSN: 07248741 NLM ISO Abbreviation: Pharm Res Subsets: MEDLINE |
| Imprint Name(s): | Publication: 1999- : New York, NY : Kluwer Academic/Plenum Publishers; Original Publication: Stuttgart ; New York : Thieme, c1984- |
| MeSH Terms: | Models, Biological*; Antibodies, Monoclonal/*pharmacokinetics ; Antineoplastic Agents, Immunological/*pharmacokinetics ; Immunoconjugates/*pharmacokinetics ; Lymphoma, Non-Hodgkin/*drug therapy; Antibodies, Monoclonal/administration & dosage ; Antineoplastic Agents, Immunological/administration & dosage ; Immunoconjugates/administration & dosage ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Body Weight ; Clinical Trials as Topic ; Computer Simulation ; Drug Dosage Calculations ; Female ; Humans ; Male ; Middle Aged ; Sex Factors ; Young Adult |
| Abstract: | Purpose: The established two-analyte integrated population pharmacokinetic model was applied to assess the impact of intrinsic/extrinsic factors on the pharmacokinetics (PK) of polatuzumab vedotin (pola) in patients with non-Hodgkin lymphoma (NHL) following bodyweight-based dosing.; Methods: Model simulations based on individual empirical Bayes estimates were used to evaluate the impact of intrinsic/extrinsic factors as patient subgroups on Cycle 6 exposures. Intrinsic factors included bodyweight, age, sex, hepatic and renal functions. Extrinsic factors included rituximab/obinutuzumab or bendamustine combination with pola and manufacturing process. The predicted impact on exposures along with the established exposure-response relationships were used to assess clinical relevance.; Results: No clinically meaningful differences in Cycle 6 pola exposures were found for the following subgroups: bodyweight 100-146 kg versus 38- |
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| Contributed Indexing: | Keywords: antibody-drug conjugate; integrated two-analyte; non-Hodgkin lymphoma; population pharmacokinetics |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal); 0 (Antineoplastic Agents, Immunological); 0 (Immunoconjugates); KG6VO684Z6 (polatuzumab vedotin) |
| Entry Date(s): | Date Created: 20201201 Date Completed: 20210803 Latest Revision: 20231112 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC7708381 |
| DOI: | 10.1007/s11095-020-02933-6 |
| PMID: | 33258982 |
| Database: | MEDLINE |
Journal Article