Enhertu wins EU approval with 53% lower recurrence risk
Key points
- Daiichi Sankyo and AstraZeneca (NYSE:AZN) received European Commission approval for Enhertu to treat eligible adults with HER2-positive early breast cancer and residual invasive disease after initial treatment.
- The DESTINY-Breast05 Phase 3 trial showed a 53% reduction in the risk of invasive disease recurrence or death compared with T-DM1, with three-year invasive disease-free survival of 92.4%.
- AstraZeneca will pay Daiichi Sankyo a US$75 million milestone following the approval, which expands Enhertu's use into an earlier treatment setting in the EU.
Daiichi Sankyo and AstraZeneca (NASDAQ:AZN) received European Union approval for Enhertu as an adjuvant treatment for eligible adults with HER2-positive early breast cancer and residual invasive disease after neoadjuvant treatment.
The approval is based on the Phase 3 DESTINY-Breast05 trial, in which Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with trastuzumab emtansine (T-DM1).
“The EU approval of trastuzumab deruxtecan, which demonstrated a more than 50% reduction in risk of recurrence compared to standard of care in DESTINY-Breast05, has the potential to change how we treat eligible patients in this setting,” said Sibylle Loibl, lead investigator of the DESTINY-Breast05 trial.
At three years, invasive disease-free survival was 92.4% among patients receiving Enhertu, compared with 83.7% for T-DM1, while the trial also reported a 53% reduction in the risk of disease recurrence or death based on disease-free survival.
Following the approval, AstraZeneca will pay Daiichi Sankyo a US$75 million milestone, and Daiichi Sankyo recognizes Enhertu sales in most EU territories.
The approval marks Enhertu's first EU authorization for early breast cancer in a curative-intent setting and its third EU approval in four months, according to the companies' announcement.
Enhertu is a HER2-directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialized with AstraZeneca, with the treatment approved in more than 35 countries and regions for the specified adjuvant indication.
