AstraZeneca says Dato-DXd improved PFS in breast cancer trial

High-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan, or Dato-DXd, demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival, or PFS, compared to investigator’s choice of chemotherapy in patients with inoperable or metastatic hormone receptor-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy, AstraZeneca announced. “A trend in improvement for the dual primary endpoint of overall survival was observed for datopotamab deruxtecan versus chemotherapy. Data for OS were not mature at this interim analysis and the trial will continue as planned to assess OS. The safety profile of datopotamab deruxtecan was consistent with previous clinical trials in breast cancer with no new safety signals identified. All grade interstitial lung disease rates were low. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate being jointly developed by AstraZeneca and Daiichi Sankyo,” the company stated.