- ENHERTU® followed by THP shows significant improvement in pathologic complete response in high-risk HER2 positive early-stage breast cancer.
- First phase 3 trial, DESTINY-Breast11, demonstrates ENHERTU's benefit in early breast cancer.
- Results to be presented at future medical meetings and shared with regulatory authorities.
The phase 3 DESTINY-Breast11 trial has revealed positive results for Daiichi Sankyo (4568) and AstraZeneca's (AZN, Financial) ENHERTU® (trastuzumab deruxtecan) when combined with paclitaxel, trastuzumab, and pertuzumab (THP). This combination showed a statistically significant and clinically meaningful improvement in pathologic complete response rates (pCR) compared to the standard care regimen of dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk, locally advanced HER2 positive early-stage breast cancer.
Pathologic complete response, indicating no evidence of invasive cancer in breast tissue and lymph nodes post-treatment, was the primary endpoint. Although the secondary endpoint of event-free survival (EFS) was immature, early data suggest a positive trend favoring the ENHERTU and THP regimen over the standard of care. The trial will continue to monitor EFS.
Approximately one-third of early-stage breast cancer patients are classified as high-risk due to their likelihood of recurrence and poor prognosis, emphasizing the need for alternative treatment strategies. Achieving a pCR is linked with improved long-term outcomes. The current neoadjuvant therapy standard mostly involves combination chemotherapy, often with anthracyclines, known for their challenging side effects. As nearly 50% of patients receiving neoadjuvant treatments fail to achieve pCR, the results from DESTINY-Breast11 offer hope for a new treatment method.
ENHERTU, a HER2-directed antibody-drug conjugate (ADC) developed using Daiichi Sankyo's proprietary technology, exhibited an improved safety profile over standard care. The study also found consistent safety results with known profiles of ENHERTU and THP, with interstitial lung disease rates similar across both treatment arms.
Discoveries from the DESTINY-Breast11 trial are set to be presented at upcoming medical meetings and will be submitted to regulatory authorities. ENHERTU is currently being evaluated in numerous breast cancer trials, including the DESTINY-Breast05 trial. The drug is already approved for various other cancer types, thanks to its demonstrated efficacy in multiple phase 3 trials.
