Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced the positive preliminary results from the Phase III DESTINY-Breast11 study. The trial evaluated Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody drug conjugate (ADC), in combination with paclitaxel, trastuzumab, and pertuzumab (THP) as a neoadjuvant therapy for high-risk, locally advanced HER2-positive early breast cancer.
Trial Results
The Enhertu-THP regimen demonstrated a statistically significant and clinically meaningful improvement in pathological complete response (pCR) rates compared to the standard-of-care regimen (dose-dense doxorubicin/cyclophosphamide followed by THP [ddAC-THP]), meeting the primary endpoint. Data for event-free survival (EFS), the secondary endpoint, were immature but showed an early favorable trend. The Enhertu-THP combination also exhibited a more favorable safety profile compared to ddAC-THP.
Enhertu Background
Co-developed and commercialized by AstraZeneca and Daiichi Sankyo, Enhertu is approved globally for multiple solid tumors, including HER2-positive breast cancer, non-small cell lung cancer (NSCLC), and gastric/gastroesophageal junction adenocarcinoma (GC/GEJC).-Fineline Info & Tech
