AstraZeneca, Daiichi post early win in Phase 3 trial for breast cancer therapy
Christoph Burgstedt

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF) announced Friday that their antibody-drug conjugate datopotamab deruxtecan reached the primary endpoint in a Phase 3 trial for the commonest type of breast cancer.
The globally run TROPION-Breast01 trial enrolled more than 700 patients with hormone receptor (HR) positive, HER2 low, or negative breast cancer, the most common cancer subtype that makes up over 65% of cases.

The selected patients had inoperable or metastatic breast cancer, which had progressed despite prior endocrine-based therapy and at least one systemic therapy.
According to an interim analysis, TROPION-Breast01 met the primary endpoint of progression-free survival (PFS), indicating a statistically significant and clinically meaningful improvement for datopotamab deruxtecan versus chemotherapy.
The data for the dual primary endpoint of overall survival was not mature, and the companies said the trial will continue, as planned, to assess that goal.
The safety profile of the experimental therapy was consistent with its prior trials in breast cancer, and there were no new safety signals, according to the drugmakers.
AstraZeneca (AZN) and Daiichi (OTCPK:DSNKY) plan to submit the data for regulatory reviews and a presentation at a future medical event.



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