China NMPA grants conditional approval to AstraZeneca & Daiichi Sankyo’s Enhertu as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.
Each year in China, more than one million people are diagnosed with lung cancer, accounting for more than 40% of the world’s lung cancer patients – the majority are diagnosed with advanced disease. Approximately 2% to 4% of patients with NSCLC have tumours with activating HER2 mutations.
Ying Cheng, MD, PhD, director of Jilin Lung Cancer Centre, China, and principal investigator of DESTINY-Lung05, said: “While there have been many advancements in the treatment of non-small cell lung cancer in China in recent years, patients with HER2-mutant disease have had few treatment options and none directed towards this specific type of lung cancer. This approval of Enhertu offers an important new targeted treatment for patients with this aggressive form of disease.”
Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said: “This approval of Enhertu represents the first HER2-directed therapy approved in China for the treatment of HER2-mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. It also reinforces the importance of testing for predictive biomarkers in lung cancer at the time of diagnosis, including HER2 mutations, to ensure patients can receive the most appropriate treatment for their specific disease.”
The safety profile of Enhertu in DESTINY-Lung02 and DESTINY-Lung05 were similar and generally consistent with previous clinical trials of Enhertu in lung cancer with no new safety concerns identified.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Enhertu is already approved for the treatment of previously treated unresectable or metastatic HER2-mutant NSCLC in more than 45 countries, including the US, Japan and across the EU.
In China, lung cancer is the most commonly diagnosed cancer with more than one million cases diagnosed in 2022. It is also the leading cause of cancer-related deaths in China, with more than 733,000 deaths reported in 2022.
A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.