Nicholas Hornstein, Assistant Professor at Northwell Health, shared Sawyer Bawek’s, Junior Chief Fellow at Cleveland Clinic, post on LinkedIn:
“A historic day for solid tumor oncology.
China has approved satri-cel (CLDN18.2 CAR-T) for advanced gastric/GEJ cancer, making it the first CAR-T therapy ever approved for a solid tumor.
For years, CAR-T has transformed hematologic malignancies while solid tumors remained left in the dust.
CT041-ST-01 (3L+ CLDN18.2+ gastric/GEJ cancer) in the Lancet.
- Median PFS: 3.25 vs 1.77 months (HR 0.37)
- Median OS: 7.9 vs 5.5 months (HR 0.69)
- 18-month OS: 20% vs 10%
- Demonstrated superiority over physician’s choice therapy in a heavily pretreated population.
The absolute numbers are not dramatic, but that isn’t the point.
This is the first regulatory approval of a CAR-T for a solid tumor.
Also notable: this happened in China, not the United States.
As China continues to accelerate development of cell therapies, ADCs, and other oncology platforms, it is increasingly becoming the site of first-in-class innovation.
Satri-cel may ultimately be remembered less for the 2.4-month OS gain and more for what it represents:
The beginning of the solid tumor CAR-T era.”
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 Lic, Wanwan Gao, Lun Gai, Yumeng Wang, Daijing Yuan, Zonghai Li, Prof Lin Shen
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