Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population
Second positive Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer reinforces its potential to become a foundational treatment option in curative-intent setting
Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo
Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance
AstraZeneca and Daiichi Sankyo’s Enhertu followed by THP showed an improved safety profile vs. standard of care
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
Application based on results from the TROPION-Breast01 Phase III trial
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