AstraZeneca : Phase III Trial Of Datopotamab Deruxtecan In Breast Cancer Shows Improvement In PFS

(RTTNews) - 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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