Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden.
| Title: | Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. |
|---|---|
| Authors: | Shemesh CS; Clinical Pharmacology, Genentech Inc., South San Francisco, CA, USA.; Chan P; Clinical Pharmacology, Genentech Inc., South San Francisco, CA, USA.; Legrand FA; Clinical Science, Genentech Inc., South San Francisco, CA, USA.; Shames DS; Biomarkers, Genentech Inc., South San Francisco, CA, USA.; Das Thakur M; Biomarkers, Genentech Inc., South San Francisco, CA, USA.; Shi J; Safety Science, F. Hoffmann-La Roche Ltd., Shanghai, China.; Bailey L; Safety Science, Roche Products Ltd., Welwyn Garden City, United Kingdom.; Vadhavkar S; Clinical Pharmacology, Genentech Inc., South San Francisco, CA, USA.; He X; Biometrics, Genentech Inc., South San Francisco, CA, USA.; Zhang W; Biometrics, Genentech Inc., South San Francisco, CA, USA.; Bruno R; Clinical Pharmacology, Genentech-Roche, Marseille, France. |
| Source: | Pharmacology research & perspectives [Pharmacol Res Perspect] 2020 Dec; Vol. 8 (6), pp. e00685. |
| Publication Type: | Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics Country of Publication: United States NLM ID: 101626369 Publication Model: Print Cited Medium: Internet ISSN: 2052-1707 (Electronic) Linking ISSN: 20521707 NLM ISO Abbreviation: Pharmacol Res Perspect Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [Hoboken, NJ] : John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics, [2013]- |
| MeSH Terms: | Antibodies, Monoclonal, Humanized/*pharmacokinetics ; Antineoplastic Agents/*pharmacokinetics ; Biomarkers, Tumor/*genetics ; Mutation/*genetics ; Neoplasms/*genetics ; Tumor Burden/*genetics; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor/metabolism ; Neoplasms/drug therapy ; Neoplasms/metabolism ; Tumor Burden/drug effects ; Adult ; Aged ; Aged, 80 and over ; Dose-Response Relationship, Drug ; Female ; Humans ; Male ; Middle Aged ; Retrospective Studies ; Treatment Outcome ; Young Adult |
| Abstract: | We retrospectively investigated the pharmacokinetics and exposure-efficacy/safety relationships of single-agent atezolizumab based on tissue tumor mutational burden (tTMB) status (high vs low [≥16 vs |
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| Contributed Indexing: | Keywords: atezolizumab; biomarkers; clinical pharmacology; mutation; pharmacokinetics; tumor |
| Molecular Sequence: | ClinicalTrials.gov NCT02008227; NCT01903993; NCT02031458; NCT01846416; NCT02302807; NCT02108652; NCT01375842 |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal, Humanized); 0 (Antineoplastic Agents); 0 (Biomarkers, Tumor); 52CMI0WC3Y (atezolizumab) |
| Entry Date(s): | Date Created: 20201126 Date Completed: 20210903 Latest Revision: 20240330 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC7689240 |
| DOI: | 10.1002/prp2.685 |
| PMID: | 33241650 |
| Database: | MEDLINE |
Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't