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AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo (OTC: DSKYF) (OTC: DSNKY) released topline data from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) in previously treated patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative breast cancer.
Dato-DXd demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival compared to the investigator's choice of chemotherapy.
Datopotamab deruxtecan's safety profile aligned with previous breast cancer clinical trials, noting no fresh safety signals. All-grade interstitial lung disease rates remained low.
While the overall survival (OS) data is yet to mature, the trial will persist in assessing this metric.
Breast cancer remains a global concern, with over two million diagnoses annually. Among these, HR-positive, HER2 low, or negative breast cancer is prevalent, making up more than 65% of cases.
Susan Galbraith, Executive Vice President, Oncology R&D, at AstraZeneca, added, "Today's TROPION-Breast01 news is a significant development for patients whose tumors have become insensitive to endocrine therapy."
In July, AstraZeneca reported topline data from the TROPION-Lung01 Phase 3 trial of Dato-DXd in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.
The company's shares fell after the data due to the lack of numerical detail, despite being statistically significant— a minimum 2-3 month benefit was targeted.
Price Action: AZN shares are up 2.66% at $68.80 during the premarket session on the last check Friday.
