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


  • Study

    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)



  • Efficacy

    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])



  • Safety

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



  • J Clin Oncol 2024;43(3):285

    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

    http://doi.org/10.1200/JCO.24.00920

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