British drug major AstraZeneca Plc. (AZN.L,AZN) announced Monday that DESTINY-Breast06 Phase III trial showed that Enhertu (trastuzumab deruxtecan) demonstrated statistically significant and clinically meaningful improvement in progression-free survival or PFS in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy.
AstraZeneca and Daiichi Sankyo's Enhertu showed positive high-level results of improvement in PFS compared to standard-of-care chemotherapy in the primary trial population of patients.
Enhertu is a specifically engineered HER2-directed DXd antibody drug conjugate or ADC discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Enhertu also demonstrated a clinically meaningful PFS improvement in patients with HER2-ultralow expression. A prespecified subgroup analysis showed the clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow expression.
The company noted that overall survival or OS data were not mature at the time of the analysis. However, Enhertu showed an early trend towards an OS improvement versus standard-of-care chemotherapy in patients with HER2-low metastatic breast cancer and in the overall trial population.
AstraZeneca said the trial will continue as planned to further assess OS and other secondary endpoints.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, "DESTINY-Breast06 shows that Enhertu could become a new standard of care for patients with HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. These data underscore the potential for treatment with Enhertu across the spectrum of HR-positive breast cancer, further redefining the treatment of metastatic breast cancer."
The data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
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