▎Edited by the WuXi AppTec content team
On February 4, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that the injectable drug Trastuzumab Deruxtecan, submitted by Daiichi Sankyo, is proposed to be included in the priority review, with the proposed indication being: existence ofHER2（ERBB2) with activating mutations who have previously received at least one systemic therapy for unresectable or metastatic disease in adultsNon-Small Cell Lung Cancer（NSCLC) patients. Trastuzumab deruxtecan is a HER2-targeted drug jointly developed by AstraZeneca and Daiichi Sankyo Company Limited.Antibody-Drug Conjugates（ADC), which has previously been approved in China for the treatment of HER2-positive and HER2-low adult breast cancer patients.。
Screenshot source: CDE official website
According to the 2022 Global Cancer Burden Report released by the International Agency for Research on Cancer (IARC) of the World Health Organization, in 2022, lung cancer replaced breast cancer as the most commonly diagnosed cancer globally. NSCLC is the main subtype of lung cancer, accounting for approximately 85% of all cases. The prognosis for patients with metastatic NSCLC is very poor, with only about 9% of patients surviving more than five years after diagnosis.HER2 is a tyrosine kinase receptor pro-growth protein expressed on the surface of various tumor cells, including lung cancer, breast cancer, gastric cancer, and colorectal cancer.In patients with non-squamous NSCLC,HER2（ERBB2) Gene alteration (referred to asHER2Gene mutation) has been identified as a unique molecular targetAbout 2% to 4% of patients with this type of lung cancer will experience this mutation.
Trastuzumab deruxtecan is a HER2-targeted ADC, developed byHumanized monoclonal antibody targeting HER2ThroughCleavable Tetrapeptide LinkerAndTopoisomerase 1 Inhibitor(DXd, a camptothecin derivative)PayloadComposed of connections. In China, this product has previously been approved for the treatment of HER2-positive and HER2-low adult breast cancer patients. Additionally, this product has already been designated three times by the CDE as a breakthrough therapy, targeting indications such as HER2-positive breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and activation.HER2（ERBB2) mutated non-small cell lung cancer.According to an earlier press release from Daiichi Sankyo, Trastuzumab Deruxtecan (5.4 mg/kg) has been approved in Israel and Japan, and has received accelerated approval in the United States for the treatment of tumors withHER2（ERBB2) activating mutations (detected by locally or regionally approved testing methods) and have previously received one systemic therapy, for adult patients with unresectable or metastatic NSCLC.Phase 2 Clinical Study Presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (#WCLC23)DESTINY-Lung02The main analysis results show that the treatment with Trastuzumab Deruxtecan Injection for previously treated patientsHER2Mutations in unresectable and/or metastatic non-squamous NSCLC continue to show clinically meaningful, durable tumor responses:- 5.4 mg/kg and 6.4 mg/kg dose groupsObjective Response Rate（ORR) were 49% and 56%, respectively.Median Progression-Free Survival（mPFS) were 9.9 months and 15.4 months, respectively.Disease Control Rate（DCR) reached 93.1% and 92.0%, respectively;
- In addition, 1 case was observed in the 5.4 mg/kg treatment group (1%）Complete Remission（CR) and 49 cases (48%）Partial Remission（PR), 2 cases were observed in the 6.4 mg/kg treatment group (4%）Complete RemissionAnd 26 patients (52%）Partial Response；
- Patients in both treatment groups showed significant and durable tumor responses.Especially, the 5.4 mg/kg dose demonstrated a better benefit/risk ratio during the treatment process.
[1] Official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Feb 4 , 2024, from
https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d[2] Trastuzumab deruxtecan granted Priority Review in the U.S. for the treatment of metastatic HER2-positive solid tumorsTumor Patients. Retrieved Jan 29, 2024, from https://mp.weixin.qq.com/s/RiO-50ktdO-WEHP-4c6r0Q
[3] Enhertu® becomes the first HER2-targeted therapy approved in Japan for HER2-mutated metastatic non-small cell lung cancer. Retrieved Aug 23, 2023, from https://mp.weixin.qq.com/s/HUjGwnEbZdSqxieFNPn9WQ
[4] The latest data from the Phase II study DESTINY-Lung02 confirmed that treatment with Enhertu® resulted in durable tumor responses in patients with previously treated HER2-mutated metastatic non-small cell lung cancer. Retrieved Sep 12, 2023, from https://mp.weixin.qq.com/s/ySbp6nXv_Sy312Q-RTysugThis article was compiled and edited by the WuXi AppTec content team based on publicly available information. Individuals are welcome to share it on their social media circles. For authorization to repost, please leave a message on the "MedView" WeChat Official Account to contact us. For other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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