WILMINGTON, DE — Positive results from the DESTINY-Breast11 Phase III trial revealed that ENHERTU® (fam-trastuzumab deruxtecan-nxki), when followed by paclitaxel, trastuzumab, and pertuzumab (THP), significantly improved pathologic complete response (pCR) rates compared to the current standard of care in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.
Pathologic complete response, a critical goal in breast cancer treatment, signifies the absence of invasive cancer cells following pre-surgery treatment. ENHERTU demonstrated a clinically meaningful improvement in pCR rates over the existing regimen of dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP).
Although data for the secondary endpoint of event-free survival (EFS) is not yet mature, early indications suggest a favorable trend for patients treated with ENHERTU and THP compared to the current standard. The trial will continue to monitor long-term outcomes.
HER2-positive breast cancer represents a particularly challenging subtype, with a third of early-stage cases considered high risk for recurrence. Current neoadjuvant approaches often involve anthracycline-based regimens, which can cause long-term cardiovascular side effects, highlighting the need for innovative treatment options.
“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,” said Susan Galbraith, Executive Vice President at AstraZeneca. “ENHERTU is already an important treatment option in the metastatic setting, and these data have the potential to allow this medicine to move into early stages of disease where cure is possible.”
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, emphasized the treatment’s potential to set more patients on the path to a cure. “These topline results demonstrate that ENHERTU followed by THP could offer patients with HER2-positive breast cancer a promising new treatment approach prior to surgery,” he said.
The trial also showed ENHERTU followed by THP had a more favorable safety profile than ddAC-THP, with fewer adverse events and no new safety concerns. Independent monitoring confirmed that rates of interstitial lung disease, a known risk, were consistent across both arms of the trial.
Developed jointly by Daiichi Sankyo and AstraZeneca, ENHERTU is an engineered HER2-directed DXd antibody drug conjugate. With success in multiple Phase III trials, including the recent DESTINY-Breast09 study, ENHERTU is poised to become a pivotal option across various stages of HER2-positive breast cancer.
Detailed findings from the DESTINY-Breast11 trial will be presented at an upcoming medical conference and submitted to regulatory authorities for evaluation.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.