China’s National Medical Products Administration (NMPA) has granted conditional approval for ENHERTU (trastuzumab deruxtecan) followed by THP (paclitaxel, trastuzumab, pertuzumab) in the neoadjuvant treatment of high-risk HER2 positive breast cancer, marking a global first for this curative-intent setting.
The decision is based on the phase 3 DESTINY-Breast11 trial, which demonstrated a superior pathologic complete response (pCR) rate for ENHERTU followed by THP compared with the standard ddAC-THP regimen (67.29% vs. 56.25%; improvement of 11.17%). Results were consistent across key subgroups, including hormone receptor positive and negative patients.
“In patients with high-risk HER2 positive early-stage breast cancer, effective neoadjuvant treatment is critical to lower the risk of disease recurrence and maximize the chance of cure while potentially enabling less intensive surgery,” said Professor Jiong Wu, Secretary of the Party Committee of Fudan University Shanghai Cancer Center and China lead investigator of DESTINY-Breast11.
“Findings from DESTINY-Breast11 showed that approximately 67% of patients had a pathologic complete response with ENHERTU followed by THP, suggesting a potential new standard of care in this setting.”
This marks ENHERTU’s seventh approval in China in three years and its third in just the last three months. Michio Hayashi, China President of Daiichi Sankyo, emphasized the significance:
“As the first approval of ENHERTU globally for the neoadjuvant treatment of HER2 positive early-stage breast cancer and the first HER2 directed antibody drug conjugate approved in China in this setting, ENHERTU followed by THP offers patients in China a new treatment option with the opportunity to reach a pathologic complete response and the potential for improved long-term outcomes.
"This third approval of ENHERTU in the last three months and seventh approval in three years reinforces the rapid progress we are making in bringing ENHERTU to more patients in China, where there is a high incidence of breast cancer and a continued need for new treatment approaches.”
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Hematology Business Unit, added: “ENHERTU followed by THP is the first treatment regimen in more than a decade to demonstrate a clinically meaningful improvement in pathologic complete response and safety in the neoadjuvant setting for patients with HER2 positive early-stage breast cancer, underscoring the significance of this new approval. ENHERTU is already an important option in the metastatic setting, and this decision will bring it into early-stage disease where cure is possible."
ENHERTU is a HER2-directed DXd antibody-drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca. known profiles of each therapy, with no new safety concerns identified.
