ENHERTU (trastuzumab deruxtecan) has been approved in China for adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low or HER2 ultralow breast cancer following progression on one or more endocrine therapies. 

 

The decision by China’s National Medical Products Administration (NMPA) marks the first HER2-directed therapy available to this underserved patient population.

 

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy. 

 

In patients with HR positive, HER2 low metastatic breast cancer, ENHERTU reduced the risk of disease progression or death by 38%. Median progression-free survival reached 13.2 months versus 8.1 months for chemotherapy, and the objective response rate was 56.5% versus 32.2%.

 

Even in the HER2 ultralow population, ENHERTU showed promising results: median PFS of 13.2 months compared with 8.3 months for chemotherapy, and an objective response rate of 61.8% versus 26.3%.

 

“For many years, tumors with low levels of HER2 expression were grouped under the broader category of HER2 negative, leaving patients with HER2 low and HER2 ultralow breast cancer without targeted treatment options after progressing on endocrine therapy,” said Xichun Hu, Chair Professor of the Department of Medical Oncology, Fudan University Shanghai Cancer Center and lead investigator of the DESTINY-Breast06 trial in China. 

 

“The DESTINY-Breast06 results demonstrate for the first time that a precision-targeted therapy can benefit this underserved population, marking an important scientific advance. With this approval, more patients can benefit from antibody drug conjugate therapy, including those with HER2 expressing, HR positive metastatic breast cancer.”

 

“This fifth approval for ENHERTU in China in less than three years underscores our commitment to bringing this innovative therapy to more patients that may benefit from treatment,” said Michio Hayashi, China President, Daiichi Sankyo. 

 

“As the first HER2 directed medicine approved in China for patients with HER2 low or ultralow disease, ENHERTU continues to redefine the diagnosis and treatment of metastatic breast cancer with this new use.”

 

Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca, added: “DESTINY-Breast06 marks a meaningful shift in the treatment of patients with HR positive breast cancer, enabling more patients to benefit from a HER2 directed treatment option. 

 

"This new approval in China underscores the critical need to test metastatic breast cancer tumors for any level of HER2 staining to identify those with HER2 low or ultralow disease that could potentially be treated with ENHERTU following disease progression on endocrine therapy.”

 

ENHERTU’s safety profile was consistent with previous clinical trials, with no new safety concerns identified. The most common severe adverse reactions included neutropenia (18%), anemia (10.5%), fatigue (7.8%), and leukopenia (6%).

 

With breast cancer being the second most common cancer among women in China, affecting approximately 357,000 people in 2022 alone, this approval offers a new lifeline for patients with HR positive, HER2-expressing tumors who previously had limited options.