Core Viewpoint - The article discusses the promising results of the CAR-T cell therapy targeting Claudin18.2 (satri-cel) for treating advanced gastric and gastro-oesophageal junction cancer, highlighting its potential as a new standard treatment option for patients who have failed multiple lines of therapy [2][3][20]. Summary by Sections Clinical Trial Overview - The study published in The Lancet presents the results of a randomized, open-label, phase 2 trial comparing satri-cel to physician's choice treatment for previously treated advanced gastric or gastro-oesophageal junction cancer [3]. - The trial involved 156 patients with CLDN18.2 positive tumors who had progressed after at least two lines of treatment [6]. Treatment Groups - Patients were randomly assigned in a 2:1 ratio, with 104 receiving satri-cel and 52 receiving standard treatment [7]. - The satri-cel group received autologous CAR-T cells at a dose of 250 million cells, with a maximum of three infusions [8]. Efficacy Results - The median progression-free survival (PFS) was significantly longer in the satri-cel group at 3.25 months compared to 1.77 months in the TPC group [9]. - The median overall survival (OS) was 7.92 months for the satri-cel group, showing a 44% increase compared to 5.49 months in the TPC group [9]. - The objective response rate (ORR) was 22% in the satri-cel group versus 4% in the TPC group [10]. - Notably, patients with peritoneal metastasis showed significant benefits from satri-cel treatment [10]. Safety Profile - In the satri-cel group, 99% of patients experienced grade 3 or higher treatment-related adverse events, primarily hematological toxicities [15]. - Cytokine release syndrome (CRS) occurred in 95% of patients, with 90% being grade 1-2, indicating manageable side effects [15]. - The TPC group had a 63% incidence of grade 3 or higher treatment-related adverse events [15]. Significance of the Study - This study marks the first successful demonstration of CAR-T cell therapy's efficacy in solid tumors, representing a milestone in cancer treatment [20]. - It provides a new effective treatment option for advanced gastric cancer patients, particularly those with poor prognosis due to peritoneal metastasis [20]. - The results pave the way for further research into CAR-T therapies for other solid tumors and highlight China's innovative capabilities in cancer immunotherapy [20].
柳叶刀：全球首个！北京大学发布CAR-T治疗实体瘤随机对照临床试验结果，为晚期胃癌带来新方案