DAIICHI SANKYO, INC.

The TROPION-Breast01 phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in the final overall survival (OS) analysis for patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer. Despite this, the trial previously met the progression-free survival (PFS) endpoint, showing a significant improvement in PFS and patient-reported outcomes. The safety profile remained consistent with no new safety concerns. The treatment landscape's advancement with multiple antibody drug conjugates (ADCs) approved during the trial may have influenced the OS results.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) missed overall survival (OS) goal in Phase III TROPION-Breast01 study, despite showing significant progression-free survival (PFS) benefits. The companies will continue regulatory discussions and apply study insights to inform future clinical development.

AstraZeneca's cancer drug Dato-DXd, acquired for up to $1 billion, failed to significantly improve overall survival in advanced breast cancer patients, following a similar setback in a lung cancer study, leading to a further decline in the company's share price.

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.

EMA’s CHMP recommended AbbVie’s ovarian cancer drug Elahere for approval in the EU, based on the MIRASOL study showing a 35% reduction in tumor progression or death. The EC will review this recommendation, with a decision expected later this year.

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.