WILMINGTON, DE — AstraZeneca and Daiichi Sankyo reported that their drug ENHERTU® (fam-trastuzumab deruxtecan-nxki) achieved highly statistically significant and clinically meaningful improvements in invasive disease-free survival (IDFS) compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer, according to results from the DESTINY-Breast05 Phase III trial.
The trial evaluated patients with residual invasive disease following neoadjuvant treatment who face a high risk of recurrence. These findings mark ENHERTU’s second major success in this disease setting, following positive results from the DESTINY-Breast11 trial earlier this year. Together, the studies strengthen ENHERTU’s position as a potential foundational therapy for HER2-positive early breast cancer in a curative-intent context.
Overall survival data remain immature and will be analyzed in a future update. Currently, about half of patients with HER2-positive early breast cancer experience residual disease after neoadjuvant therapy, putting them at greater risk of relapse and progression to metastatic disease despite existing post-surgical treatment standards.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, said the results show ENHERTU’s superiority over T-DM1 in this high-risk population and represent a major advancement in early-stage treatment. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that optimizing therapy at this stage offers the best opportunity to prevent progression to metastatic disease.
The safety profile observed in DESTINY-Breast05 was consistent with previous data, with no new safety signals identified. ENHERTU, a HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo, is jointly commercialized by both companies.
Full results from DESTINY-Breast05 and DESTINY-Breast11 will be presented during the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress on October 18, 2025, with data also to be shared with global regulators. The DESTINY-Breast05 study was conducted in collaboration with several international oncology research groups, including the NSABP Foundation, German Breast Group, AGO-B, and SOLTI Breast Cancer Research Group.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.