DAIICHI SANKYO, INC.

AstraZeneca's breast cancer drug, datopotamab deruxtecan, failed to show 'statistical significance' in a Phase 3 trial, affecting patients' 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. Shares fell following the announcement.

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.

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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%.

AstraZeneca's TROPION-Breast01 trial for metastatic HR-positive breast cancer did not improve overall survival but showed meaningful progression-free survival improvement. Meanwhile, Fasenra received EU approval recommendation for EGPA treatment, with 60% remission rate and 41% oral corticosteroid discontinuation.

TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in overall survival (OS) analysis for inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative breast cancer patients, despite meeting progression-free survival (PFS) primary endpoint.