Datopotamab deruxtecan

AstraZeneca and Daiichi Sankyo's experimental breast cancer drug, datopotamab deruxtecan, failed to extend survival in a Phase 3 trial, complicating its approval prospects despite delaying tumor progression. The drug, part of a lucrative alliance, faces a complex path to market in breast cancer, potentially giving Gilead's Trodelvy an advantage.

AstraZeneca's TROPION-Breast01 Phase III trial did not meet statistical significance in overall survival (OS) for datopotamab deruxtecan in HR-positive, HER2-low or negative breast cancer patients. However, the trial previously met its progression-free survival (PFS) endpoint with statistically significant and clinically meaningful improvement, published in the Journal of Clinical Oncology. The drug's safety profile remained consistent with lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy. AstraZeneca and Daiichi Sankyo will continue discussions with regulatory authorities based on these results.

Final OS analysis of TROPION-Breast01 trial shows datopotamab deruxtecan (Dato-DXd) did not significantly improve overall survival in pretreated HR+/HER2- breast cancer patients compared to chemotherapy. Dato-DXd did show significant PFS improvement and better PROs, with a consistent safety profile. The FDA accepted a BLA for Dato-DXd in April 2024, and final OS results will be presented and submitted for regulatory review.

AstraZeneca's breast cancer drug, datopotamab deruxtecan, failed to show 'statistical significance' in a Phase 3 trial, affecting patient survival compared to chemotherapy. The trial involved over 700 patients with inoperable or metastatic breast cancer. AstraZeneca plans to present the data to regulators, though approval is now less likely.

AstraZeneca's TROPION-Breast01 Phase III trial of datopotamab deruxtecan did not show statistical significance in final overall survival analysis, despite meeting progression-free survival (PFS) endpoint. Datopotamab deruxtecan, a TROP2-directed DXd ADC co-developed by AstraZeneca and Daiichi Sankyo, demonstrated significant PFS improvement and patient-reported outcomes. Further trials are ongoing for triple-negative and HR-low, HER2-negative breast cancers.

TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in overall survival (OS) analysis for HR-positive, HER2-low or negative breast cancer patients, despite previously meeting progression-free survival (PFS) endpoints.

AstraZeneca and Daiichi Sankyo's TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) for HR-positive, HER2-low or negative breast cancer did not meet overall survival (OS) significance but showed significant progression-free survival (PFS) improvement and better patient quality of life. Safety profile consistent with previous analyses, with lower Grade 3 or higher adverse events compared to chemotherapy.

AstraZeneca's experimental drug, datopotamab deruxtecan (Dato-DXd), developed with Daiichi Sankyo, did not significantly improve overall survival for breast cancer patients in a late-stage trial, following similar results in lung cancer trials. The drug previously met progression-free survival goals.

AstraZeneca's cancer drug, datopotamab deruxtecan, failed to meet targets in a Phase 3 trial, jeopardizing U.S. FDA approval. Shares dropped 1.2%.