Enhertu with Pertuzumab approved in China for 1L HER2-positive metastatic Breast cancer

CAR-T Digest - August 2020

Weekly Digest - August 2026

12 August 2026: Enhertu with Pertuzumab approved in China for 1L HER2-positive metastatic Breast cancer

Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab has been approved by China’s NMPA for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, marking Enhertu’s fourth approval in China in less than a year
The approval is based on the Phase 3 DESTINY-Breast09 trial, where Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus taxane, trastuzumab and pertuzumab (PFS HR=0.56), with median PFS of 40.7 months vs. 26.9 months. The combination also achieved an 85.1% confirmed ORR versus 78.6% with THP, with median duration of response of 39.2 vs. 26.4 months, demonstrating durable disease control in the first-line setting
The approval addresses a major unmet need in first-line metastatic HER2-positive breast cancer, where patients have historically been treated with taxane, trastuzumab and pertuzumab, while Enhertu plus pertuzumab offers a more effective treatment option with significantly longer progression-free survival
Enhertu is a HER2-directed ADC comprising a HER2 monoclonal antibody linked to multiple topoisomerase I inhibitor DXd payloads through tetrapeptide-based cleavable linkers, enabling targeted delivery and intracellular release of the cytotoxic payload
Strategically, the China approval strengthens Enhertu’s position in the first-line HER2-positive metastatic breast cancer landscape, with the combination’s more than three-year median PFS supporting its potential as a new standard of care and further expanding Daiichi Sankyo and AstraZeneca’s HER2 ADC franchise