WILMINGTON, Del.– AstraZeneca and Daiichi Sankyo announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki) significantly improved invasive disease-free survival compared to trastuzumab emtansine (T-DM1) in the DESTINY-Breast05 Phase III trial. The findings mark the second positive Phase III study for ENHERTU in HER2-positive early breast cancer, reinforcing its potential as a foundational treatment in the curative-intent setting.
Results from both DESTINY-Breast05 and the earlier DESTINY-Breast11 trial will be presented October 18 during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025.
The interim analysis of DESTINY-Breast05 showed patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy experienced a highly statistically significant and clinically meaningful improvement in invasive disease-free survival with ENHERTU compared to T-DM1. Overall survival data were not yet mature and will be evaluated in future analyses.
“ This landmark trial is the first to directly compare ENHERTU and T-DM1 in early breast cancer, and the results clearly show that ENHERTU delivers superior outcomes,” said Susan Galbraith, executive vice president of Oncology Haematology R&D at AstraZeneca. “Coupled with DESTINY-Breast11, these results highlight our commitment to advancing ENHERTU into early-stage disease, where patients have the greatest opportunity for cure.”
Ken Takeshita, global head of R&D at Daiichi Sankyo, added: “For patients with residual disease following neoadjuvant treatment, this represents the last opportunity to prevent progression to metastatic disease. DESTINY-Breast05 shows that ENHERTU can extend the time patients live free of invasive disease, offering a new approach in the post-neoadjuvant setting.”
The safety profile observed in DESTINY-Breast05 was consistent with previous studies, with no new concerns reported.
ENHERTU, a specifically engineered HER2-directed antibody drug conjugate, is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The DESTINY-Breast05 trial was conducted in collaboration with NSABP, the German Breast Group, AGO-B, and the SOLTI Breast Cancer Research Group.
Data from both DESTINY-Breast05 (Abstract #LBA1) and DESTINY-Breast11 (Abstract #291O) will also be shared with regulatory authorities worldwide.
