Tanja Obradovic, Therapeutic Strategy Lead of Oncology at Novotech, Senior Advisor of Oncology Drug Development at HopeAI, shared a post on LinkedIn:
“Enormous step forward for the whole field of cell therapy just happened yesterday with CARsgen Therapeutics satricabtagene autoleucel (satri-cel) CAR-T therapy receiving approval by China’s National Medical Products Administration (NMPA) for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
Satricabtagene autoleucel (satri-cel) is autologous humanized Claudin18.2 CAR T-cell product and it showcases innovative engine from China where it already has 5 trials including two in adjuvant setting for pancreatic and gastric/gastroesophageal junction adenocarcinoma. It is truly major move as a first CAR-T cell product to successfully report delivering benefit in patients with solid tumors and targeting antigen Claudin18.2 as a valid marker for cell therapy.
In addition to CAR-T cells administration, there is innovative approach to the challenge of the tumor microenvironment in treating solid tumors with application of the novel preconditioning regimen. This regimen features the addition of low-dose nab-paclitaxel to the conventional lymphodepletion regimen comprising cyclophosphamide and fludarabine to enhance the infiltration and anti-tumor efficacy of CAR T cells.
Satricabtagene autoleucel (satri-cel) is now facing global validation of data outside of China. The FDA has granted Satri-cel Orphan Drug designation (September 2020) and Regenerative Medicine Advanced Therapy (RMAT) designation (January 2022) to expedite development, and it is now in the USA clinical trial in patients with advanced gastric or gastroesophageal junction cancer, pancreatic adenocarcinoma or biliary tract cancers (including intrahepatic/extrahepatic cholangiocarcinoma and gallbladder cancer).
Truly outstanding results in the CAR-T cell therapy field and hopefully beginning of the global reach for patients.”
Title: Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician’s choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial
Authors: Changsong Qi, Chang Liu, Zhi Peng, Yanqiao Zhang, Jia Wei, Wensheng Qiu, Xiaotian Zhang, Hongming Pan, Zuoxing Niu, Meng Qiu, Yanru Qin, Weijia Fang, Feng Ye, Ning Li, Tianshu Liu, Anwen Liu, Xizhi Zhang, Changlu Hu, Jun Zhang, Jiuwei Cui, Xiaoyan Lin, Shubin Wang, Jian Zhang, Tongyu Lin, Xiujuan Qu, Xianglin Yuan, Jifang Gong, Jian Li, Wanwan Gao, Lun Gai, Yumeng Wang, Daijing Yuan, Zonghai Li, Lin Shen
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