New Drug: Datopotamab Deruxtecan for HR+, her2 Neg Breast Cancer

Phase 3, open-label, randomized study (TROPION-Breast01)

Inoperable or metastatic HR+/HER2– breast cancer, previously treated with 1 or 2 lines of chemotherapy in the inoperable/metastatic setting

Datopotamab q21 (n=365) vs. investigator’s choice of chemotherapy (eribulin, capecitabine, vinorelbine, gemcitabine) (n=367)

ORR: 36.4% vs. 22.9% (datopotamab vs. ICC) (OR: 1.95 [1.41-2.71])

mDoR: 6.7 mos vs. 5.7 mos

mPFS: 6.9 mos vs. 4.9 mos (HR: 0.63 [0.52-0.76])

Grade ≥3 TRAEs: Neutropenia (10.8% Dato-DXd vs. 42.5% ICC), Anemia (11.1% vs. 19.7%)

Bardia A,Jhaveri K,Im SA Datopotamab Deruxtecan Versus Chemotherapy in Previously Treated Inoperable/Metastatic Hormone Receptor–Positive Human Epidermal Growth Factor Receptor 2–Negative Breast Cancer: Primary Results From TROPION-Breast01

Reviewed by Ulas D. Bayraktar, MD on Jan 20, 2025