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Enhertu improved pCR in early-stage breast cancer
Enhertu improved pCR in early-stage breast cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n07 May 2025\n \nEnhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial\n \nAstraZeneca and Daiichi Sankyo's Enhertu followed by THP\nshowed an improved safety profile vs. standard of care\n \nFirst Phase III trial to demonstrate benefit of Enhertu in early breast cancer\n \nPositive high-level results from the DESTINY-Breast11 Phase III trial showed Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) demonstrated a statistically significant and clinically meaningful improvement in pathologic complete response (pCR) rate versus standard of care (dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP]) when used in the neoadjuvant setting (before surgery) in patients with high-risk, locally advanced HER2-positive early-stage breast cancer. Pathologic complete response is defined as no evidence of invasive cancer cells in the removed breast tissue and lymph nodes following treatment.\n \nThe secondary endpoint of event-free survival (EFS) was not mature at the time of analysis; however, EFS data showed an early positive trend favouring Enhertu followed by THP compared to standard of care. The trial will continue to follow EFS.\n \nApproximately one in three patients with early-stage breast cancer are considered high risk, as they are more likely to experience disease recurrence and have a poor prognosis.1,2 Achieving pCR in early-stage HER2-positive breast cancer is associated with improved long-term outcomes.2,3 The current standard of care in many regions of the world in this neoadjuvant setting involves combination chemotherapy regimens.2 These regimens often include anthracyclines, which can be challenging for patients to tolerate and may result in long-term cardiovascular side effects.4 Further, nearly half of patients who receive neoadjuvant treatment do not achieve pCR, reinforcing the need for new treatment options.2,3\n \nSusan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: \"The clinically meaningful improvement in pathologic complete response and the safety data seen in DESTINY-Breast11 highlight the poten...