Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators' choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2-) breast cancer: TROPION-Breast01

Chemotherapy is the main treatment in patients (pts) with pretreated endocrine-resistant HR+/HER2– metastatic breast cancer (BC), but has limited efficacy and substantial toxicities. The antibody-drug conjugate Dato-DXd consists of a humanized IgG1 mAb targeting TROP2 attached via a stable cleavable linker to a topoisomerase I (TopI) inhibitor payload. The TROPION-PanTumor01 (NCT03401385) study of Dato-DXd in heavily pretreated, metastatic, triple-negative BC showed a manageable safety profile and highly encouraging objective response rates (ORR by blinded independent central review [BICR]: 34% in all pts; 52% in pts treatment-naïve to TopI inhibitor-based therapies).