Population-estimated clearance of Trastuzumab Emtansine (T-DM1)
Estimates the clearance of Trastuzumab Emtansine (T-DM1), a HER2-targeted antibody-drug conjugate, in patients with HER2-positive metastatic breast cancer. The model was based on pooled data from a phase I trial and 2 phase II trials.
Research authors: Gupta M, Lorusso PM, Wang B, Yi JH, Burris HA 3rd, Beeram M, Modi S, Chu YW, Agresta S, Klencke B, Joshi A, Girish S.
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Population-estimated clearance of trastuzumab emtansine L/d

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Conditional information

This population pharmacokinetic (PK) model by Gupta et al1 estimates the clearance of trastuzumab emtansine (T-DM1) based on a large and representative patient population that has received prior trastuzumab-based therapy. This model should support exposure comparisons of different dosage regimens, as well as PK and pharmacodynamic studies of T-DM1. Patients with larger body weight, lower albumin, higher tumor burden, and higher AST had faster clearance. Creatinine clearance was found to have no influence on T-DM1 clearance.1

Limitations of the model:
The applicability of the derived population PK model might be limited to the T-DM1 concentration ranges where PK is linear. The PK of T-DM1 in patients on earlier lines of therapy has yet to be fully elucidated from ongoing trials.1

Model performance: 
In a study by Gupta et al (2012), there was good agreement between observed and predicted concentrations. The goodness-of-fit plots for the model demonstrated good agreement between the observed and predicted concentration values.
Body weight, albumin, tumor burden, and AST were statistically significant covariates that influenced the pharmacokinetics of T-DM1, explaining 37%
of interindividual variance in the clearance of T-DM1. Interindividual variability of clearance was reduced from 26.4% to 21% (decrease of 36.7%) after adding the models' covariates.1 

1Gupta M, Lorusso PM, Wang B et al. Clinical implications of pathophysiological and demographic covariates on the population pharmacokinetics oftrastuzumab emtansine, a HER2- targeted antibody-drug conjugate, in patients with HER2-positive metastaticbreast cancer. Journal of Clinical Pharmacology, 2012;52:691-703.

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