AstraZeneca (AZ) has reported positive Phase III DESTINY-Breast05 results showing Enhertu (trastuzumab deruxtecan) significantly improved invasive disease-free survival (IDFS) versus ado-trastuzumab emtansine in high-risk HER2-positive early breast cancer patients with residual disease after neoadjuvant therapy. The global randomised open-label trial enrolled 1,635 patients comparing 5.4mg/kg trastuzumab deruxtecan against 3.6mg/kg ado-trastuzumab emtansine as adjuvant treatment with safety profile consistent with known characteristics of the antibody-drug conjugate (ADC). Approximately 50% of HER2-positive early breast cancer patients present residual disease post-neoadjuvant treatment indicating elevated recurrence risk requiring enhanced therapeutic approaches.

The trial represents first head-to-head comparison between next-generation and standard ADCs in early breast cancer setting with highly statistically significant improvement in primary endpoint. Overall survival (OS) data remain immature at interim analysis with subsequent assessments planned. AZ executive Susan Galbraith highlighted potential for trastuzumab deruxtecan to become new standard for high-risk patients following neoadjuvant therapy based on superior efficacy demonstrated across DESTINY-Breast05 and DESTINY-Breast11 trials investigating neoadjuvant application.

According to PharmCube's NextBiopharm® database, Enhertu has entered development in 57 indications, including seven approved and eight in Phase III. Click here to request a free trial for NextBiopharm®.