New Beijing News (Reporter Zhang Xiulan) On August 13th, the official website of the National Medical Products Administration (NMPA) showed that the antibody coupled drug (ADC) Uxostat (injectable trastuzumab) has been conditionally approved for the treatment of locally advanced or metastatic HER2 positive adult gastric or gastroesophageal junction adenocarcinoma patients who have received two or more treatment regimens in the past.
Gastric cancer is a highly prevalent type of cancer in China, with approximately 359000 new cases and 260000 deaths reported in 2022. It is worth noting that the proportion of early stage gastric cancer patients in China is low, with about 65% of patients entering the middle and late stages when diagnosed. Treatment options for late stage gastric cancer are scarce, and patients have limited benefits, with a five-year survival rate of less than 10%. HER2 is one of the important targets of gastric cancer, with about 20% of HER2 positive gastric cancer patients. This type of gastric cancer is more invasive and prone to recurrence and metastasis. Professor Shen Lin, Director of the Digestive Oncology Department at Peking University Cancer Hospital, stated that HER2 positive advanced gastric cancer is highly invasive and difficult to treat. Once patients progress after receiving first-line treatment and subsequent chemotherapy, the prognosis is often poor. "The ADC drug trastuzumab can bring clinically significant benefits to patients after previous treatment has progressed, and its approval will bring an important new targeted therapy option for HER2 positive metastatic gastric cancer patients in China
The drug was jointly developed and commercialized by the First Third Republic and AstraZeneca, and this approval is the third indication for Uhyide approved in China. Research has shown that compared to chemotherapy, Ujide exhibits clinically significant persistent response in advanced HER2 positive gastric cancer patients. As of June 16, 2023, the confirmed objective response rate (ORR) was 28.8%, and the median progression free survival (mPFS) was 5.7 months.
At present, trastuzumab has been recommended by multiple authoritative guidelines both domestically and internationally. The 2024 CSCO Gastric Cancer Diagnosis and Treatment Guidelines include it in third line and above treatments; In the 2023NCCN (National Comprehensive Cancer Network), ASCO (American Society of Clinical Oncology), and ESMO (European Society of Oncology) guidelines, it is recommended for the posterior treatment of HER2 positive advanced gastric cancer patients.