AstraZeneca and Daiichi Sankyo Report Phase 3 TROPION-Breast01 Results for Dato-DXd

AstraZeneca and Daiichi Sankyo today announced positive results from the Phase 3 TROPION-Breast01 trial evaluating datopotamab deruxtecan (Dato-DXd) in patients with hormone receptor-positive, HER2-negative unresectable or metastatic breast cancer. The trial met its primary endpoint of progression-free survival, demonstrating a statistically significant improvement compared to chemotherapy. Dato-DXd is a TROP2-directed antibody-drug conjugate (ADC) that delivers a topoisomerase I inhibitor payload to cancer cells. These results support the potential of Dato-DXd as a new treatment option for this patient population. Regulatory submissions are planned based on these results.