Datopotamab Deruxtecan is an antibody–drug conjugate for patients with metastatic hormone receptor–positive breast cancer.
It consists of the humanized, anti-TROP-2 IgG1 monoclonal antibody conjugated to a potent topoisomerase I inhibitor.
Dato-DXd trade name.
In patients with inoperable or metastatic hormone receptor–positive (HR-positive), HER2-negative breast cancer who had received previous chemotherapy and were resistant to endocrine therapy, the antibody–drug conjugate datopotamab deruxtecan improved progression-free survival (PFS) by two months compared with chemotherapy (TROPION-Breast01 trial).
All groups benefited from the antibody–drug conjugate regardless of age, race, ECOG (Eastern Cooperative Oncology Group) Performance Status, number of prior lines of therapy, prior use of CDK4/6 inhibitors, or prior use of taxanes and/or anthracyclines.
The difference in PFS separated early and increased over time.
Confirmed objective response rate was improved with the antibody–drug conjugate (36.4% vs. 22.9%).
The OS rates favored the datopotamab deruxtecan arm.
At a median follow-up of 10.8 months, three times as many patients were still on datopotamab deruxtecan as were on chemotherapy.
Patients receiving datopotamab deruxtecan had a lower rate of grade 3 or greater treatment-related adverse events.
Two patients receiving datopotamab deruxtecan had grade 3 or greater drug-related interstitial lung disease.