Plans for new filings based on Enhertu data

9 August 2021

AstraZeneca (LSE: AZN) and Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) significantly improved progression-free survival in the Phase III DESTINY-Breast03 head-to-head trial versus trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer.

At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that the trial met the primary endpoint of progression-free survival (PFS) showing a highly statistically-significant and clinically meaningful improvement for patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

"Future opportunities to bring this benefit to patients in earlier treatment settings"Enhertu also showed a strong trend toward improved overall survival (OS) compared to T-DM1 in a key secondary endpoint, although the OS data are still immature.

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