China’s NMPA approved Daiichi Sankyo and AstraZeneca’s ENHERTU in HER2-low metastatic Breast Cancer

CAR-T Digest - August 2020

12 Jul 2023: ENHERTU (trastuzumab deruxtecan) / HER2-low metastatic breast cancer / Daiichi Sankyo / AstraZeneca: Received China NMPA approval

This approval was based on the results from the Phase 3 DESTINY-Breast04 study evaluating the efficacy and safety of Enhertu vs Chemo in 2L HER2-low metastatic Breast Cancer
Enhertu is a specifically engineered HER2-directed antibody-drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo
Efficacy: (Trastuzumab deruxtecan vs Chemo)
- ENHERTU reduced the risk of disease progression or death by 50% vs Chemo
- mPFS: 9.9 months vs 5.1 months (HR: 0.50; 95% CI; p<0.0001)
- mOS: 23.4 months vs 16.8 months
Safety:
- The safety profile observed in the DESTINY-Breast04 trial was consistent with that seen in other trials of Enhertu in breast cancer
- No new safety signals identified
“This approval of Enhertu for patients with HER2-low metastatic breast cancer, which comes shortly after the approval of Enhertu in patients with HER2-positive disease, marks the first time patients with HER2-low tumours will have the opportunity to be treated with a HER2-directed therapy. Enhertu now has the potential to become a new standard of care treatment option in China for a broad range of patients with HER2-expressing metastatic breast cancer.” said Kiminori Nagao, Head of the Asia, South & Central America (ASCA) Business Unit, Daiichi Sankyo