LONDON (dpa-AFX) - AstraZeneca announced that the Phase III DESTINY-Breast05 trial demonstrated ENHERTU (fam-trastuzumab deruxtecan-nxki) significantly improves invasive disease-free survival (IDFS) in patients with HER2-positive early breast cancer who are at high risk of recurrence. The trial evaluated ENHERTU as a post-neoadjuvant therapy, comparing it to trastuzumab emtansine (T-DM1) in patients with residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant treatment.
ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
ENHERTU demonstrated a 53% reduction in the risk of invasive disease recurrence or death compared to T-DM1. At the three-year mark, 92.4% of patients treated with ENHERTU were alive and free of invasive disease, versus 83.7% in the T-DM1 group. These IDFS benefits were consistent across all prespecified subgroups.
In addition to IDFS, ENHERTU significantly improved other key secondary endpoints. It reduced the risk of overall disease recurrence or death (disease-free survival, DFS) by 53%, lowered the risk of distant recurrence (distant recurrence-free interval, DRFI) by 51%, and decreased the risk of brain metastases (brain metastasis-free interval, BMFI) by 36% compared to T-DM1.
At the time of the interim analysis, overall survival (OS) data were not mature, with only 2.9% maturity at the data cut-off. Further analyses will be conducted to assess OS outcomes.
The safety profile of ENHERTU in this trial was consistent with previously known data, and no new safety concerns were identified.
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