Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial

This analysis evaluated how sacituzumab govitecan (SG) is processed in the body for patients with hormone receptor–positive/HER2-negative metastatic breast cancer, using updated data from the Phase 3 TROPiCS-02 trial along with earlier studies. Researchers confirmed that their existing population pharmacokinetic models accurately described drug levels for SG, its active metabolite SN-38, and the total antibody. Key patient factors—such as age, mild-to-moderate kidney or liver impairment, genetic differences (UGT1A1), albumin levels, tumor type, and Trop-2 expression—did not have a meaningful effect on drug exposure. These results support continuing the standard dosing regimen of 10 mg/kg on days 1 and 8 in a 21-day treatment cycle.