In This Article:
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan), followed by paclitaxel, trastuzumab and pertuzumab (THP), has shown pathologic complete response (pCR) rate improvement in the randomised DESTINY-Breast11 Phase III trial.
The study is targeted at patients with high-risk, locally advanced human epidermal growth factor receptor 2 (HER2)-positive early-stage breast cancer.
These improvements were observed in comparison to the standard of care, which includes dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP), in a neoadjuvant setting in these patients.
The trial’s primary endpoint is pCR, with secondary endpoints including event-free survival (EFS), overall survival, safety, and invasive disease-free survival.
The open-label, multi-centre global trial has enrolled 927 subjects across Europe, Asia, North America, and South America. It aims to assess the safety and efficacy of neoadjuvant Enhertu single agent (5.4mg/kg) or Enhertu followed by THP versus the standard of care regimen.
EFS indicated an early positive trend for Enhertu followed by THP over the standard of care, although these results were not mature during the analysis period. The trial will continue to monitor EFS outcomes.
In terms of safety, Enhertu, followed by THP, demonstrated an improved profile against ddAC-THP.
The companies noted that the safety profiles for both Enhertu and THP were found to be consistent with previously known profiles, without any safety concerns observed.
An independent adjudication committee determined that the rates of interstitial lung disease were comparable between the two treatment arms.
After a recommendation by the Independent Data Monitoring Committee, patient enrolment in a third arm of the study evaluating Enhertu only was closed after an earlier interim efficacy evaluation of the trial arms.
AstraZeneca oncology haematology research and development (R&D) executive vice president Susan Galbraith said: “The clinically meaningful improvement in pathologic complete response and the safety data seen in DESTINY-Breast11 highlight the potential of Enhertu to challenge the current standard of care in early-stage HER2-positive breast cancer.”
Discovered by Daiichi Sankyo, Enhertu is stated to be a HER2-directed DXd antibody drug conjugate (ADC) and is being co-developed and commercialised by both companies.
In March, Enhertu demonstrated a clinically meaningful improvement in overall survival in the DESTINY-Gastric04 Phase III trial for patients with gastric or gastroesophageal junction adenocarcinoma.