Datopotamab Deruxtecan

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. 


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