The Babak Lab, shared a post on LinkedIn:
“Clinical Mondays: The world’s first CAR T therapy approved for a solid tumor.
China’s NMPA has approved satricabtagene autoleucel, or satri-cel, for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy.
Key insights:
- Satri-cel targets Claudin18.2, a promising biomarker in gastric and gastroesophageal junction cancers
- This is the first approved CAR T-cell therapy for a solid tumor
- The approval is supported by CT041-ST-01, a randomized phase 2 trial published in The Lancet
- Median progression-free survival improved with satri-cel: 3.25 months vs 1.77 months with treatment of physician’s choice
- Objective response rate reached 22% with satri-cel vs 4% with standard treatment
- Disease control rate was 63% with satri-cel vs 25% with standard treatment
Conclusion:
- This marks an incredibly important milestone for cell therapy: CAR T cells may have entered a new solid tumor space.
Image generated using Sora by OpenAI. Links to both sources, CARsgen announcement and The Lancet publication, can be found in the comments section.”
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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