Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been officially launched in the Chinese market. The drug received marketing approval in China in February 2023 and is now available for the treatment of unresectable or metastatic HER2 positive adult breast cancer patients who have previously received one or more anti-HER2 drugs.
Phase III DESTINY-Breast03 Study Results
The Phase III DESTINY-Breast03 study demonstrated significant benefits of Enhertu in the second-line treatment of HER2 positive advanced breast cancer. The study showed that Enhertu significantly extended the median progression-free survival to 28.8 months, with 21.1% of patients achieving complete remission, and reduced the risk of death by 36%.
Global Development and Commercialization Agreement
AstraZeneca entered into a USD 6.9 billion licensing deal with Daiichi Sankyo in April 2019 to jointly develop and commercialize Enhertu globally, with Daiichi retaining rights in Japan. This strategic partnership underscores the significance of Enhertu in the global oncology landscape.
Early Access and Regulatory Status in China
Enhertu was first made available in China through the Bo’Ao Lecheng medical pilot zone in Hainan in November 2021. The drug was awarded breakthrough therapy designation (BTD) and priority review statuses in April 2022, highlighting its potential impact on the treatment of HER2 positive breast cancer in the country.-Fineline Info & Tech
