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| Content Provider | PubMed Central |
|---|---|
| Author | Chudasama, Vl Stark, F. Schaedeli Harrold, Jm Tibbitts, J. Girish, Sr Gupta, M. Frey, N. Mager, De |
| Copyright Year | 2012 |
| Abstract | Trastuzumab emtansine (T-DM1) is an antibody–drug conjugate (ADC) composed of multiple molecules of the antimicrotubule agent DM1 linked to trastuzumab, a humanized anti–human epidermal growth factor receptor 2 (HER2) monoclonal antibody. Pharmacokinetics data from phase I (n = 52) and phase II (n = 111) studies in HER2-positive metastatic breast cancer patients show a shorter terminal half-life for T-DM1 than for total trastuzumab (TTmAb). In this work, we translated prior preclinical modeling in monkeys to develop a semi-mechanistic population pharmacokinetics model to characterize T-DM1 and TTmAb concentration profiles. A series of transit compartments with the same disposition parameters was used to describe the deconjugation process from higher to lower drug-to-antibody ratios (DARs). The structure could explain the shorter terminal half-life of T-DM1 relative to TTmab. The final model integrates prior knowledge of T-DM1 DARs from preclinical studies and could provide a platform for understanding and characterizing the pharmacokinetics of other ADC systems. |
| Related Links | http://dx.doi.org/10.1038/clpt.2012.153 |
| Ending Page | 527 |
| Page Count | 8 |
| Starting Page | 520 |
| File Format | |
| ISSN | 15326535 |
| e-ISSN | 15326535 |
| Journal | Clinical pharmacology and therapeutics |
| Issue Number | 4 |
| Volume Number | 92 |
| Language | English |
| Publisher Date | 2012-10-01 |
| Access Restriction | Open |
| Subject Keyword | Research in Higher Education |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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