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. 2024 Apr 5;63(5):669–681. doi: 10.1007/s40262-024-01366-3
Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate of free SN-38 approved for treating patients with metastatic triple-negative breast cancer (mTNBC) who received two or more prior chemotherapies, with at least one of the chemotherapies for metastatic cancer.
Using data from 529 patients with mTNBC or other solid tumors, three population pharmacokinetic models for SG, free SN-38, and total antibody were developed and characterized the pharmacokinetics of SG and its components.
The presented analyses demonstrate that age, sex, race, tumor type, renal impairment, hepatic impairment, UGT1A1 genotype, use of UGT1A1 inducers/inhibitors, and Trop-2-expression had no clinically relevant impact on exposure of SG or its components; these findings support that no dose adjustment is needed based on these evaluated covariates or disease characteristics.