LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) and Daiichi Sankyo (DSKYF.PK)
said positive results from the pivotal TROPION-Breast01 Phase III trial showed
that datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant
and clinically meaningful improvement in progression-free survival or PFS
compared to investigator's choice of chemotherapy in patients with inoperable or
metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+
or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy
and at least one systemic therapy.

Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody
drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.

The companies noted that datopotamab deruxtecan reduced the risk of disease
progression or death by 37%, providing a 2-month median PFS benefit, and was
well tolerated in post-endocrine therapy setting.

For the dual primary endpoint of overall survival, interim results numerically
favored datopotamab deruxtecan over chemotherapy, however, results did not reach
statistical significance at the time of this data cut-off. The trial is ongoing
to assess overall survival.

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