ENHERTU followed by THP approved in China as the first and only HER2 directed ADC for the neoadjuvant treatment of HER2 positive breast cancer

CAR-T Digest - August 2020

Weekly Digest - April 2026

27 March 2026: ENHERTU followed by THP approved in China as the first and only HER2 directed ADC for the neoadjuvant treatment of HER2 positive breast cancer

ENHERTU in combination with THP has been approved in China for neoadjuvant treatment of patients with HER2-positive high-risk early-stage breast cancer, marking its first global approval in a curative-intent setting
The decision is based on the Phase 3 DESTINY-Breast11 trial, which evaluated ENHERTU followed by THP versus standard ddAC-THP in patients with high-risk HER2-positive early-stage disease
In the study, ENHERTU followed by THP demonstrated a higher pCR rate compared to standard therapy (67.3% vs. 56.3%), indicating improved efficacy in the neoadjuvant setting
The safety profile was consistent with known therapies and manageable, supporting the potential of this regimen to improve treatment outcomes in early-stage HER2-positive breast cancer
This approval addresses an unmet need, as a significant proportion of patients receiving neoadjuvant therapy do not achieve pathologic complete response (pCR), which is associated with a higher risk of recurrence