Drugmaker AstraZeneca said on Monday that high-level results from a pivotal DESTINY-Breast04 Phase III trial showed that its Enhertu drug candidate demonstrated a “statistically significant and clinically meaningful improvement” in both progression-free survival and overall survival in patients with HER2-low unresectable and/or metastatic breast cancer, regardless of hormone receptor status, versus physician’s choice of chemotherapy.
AstraZeneca stated DESTINY-Breast04 met its primary endpoint, where Enhertu demonstrated “superior” PFS in previously treated patients with HR-positive HER2-low metastatic breast cancer compared to the standard-of-care chemotherapy.
The FTSE 100-listed firm added that the trial also met its key secondary endpoint of progression-free survival in patients with HER2-low metastatic breast cancer regardless of hormone receptor status and also met its key secondary endpoints of overall survival in patients with HR-positive disease and in patients regardless of hormone receptor status at interim analysis.
Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D said: “Today’s historic news from DESTINY-Breast04 could reshape how breast cancer is classified and treated. A HER2-directed therapy has never-before shown a benefit in patients with HER2-low metastatic breast cancer. These results for Enhertu are a huge step forward and could potentially expand our ability to target the full spectrum of HER2 expression, validating the need to change the way we categorise and treat breast cancer.”
