CARsgen Therapeutics has shared the results of the pivotal phase 2 clinical trial in China investigating a Claudin18.2-specific autologous CAR-T cell product candidate, satricabtagene autoleucel, in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment.
In the first randomized controlled trial of CAR T-cell therapy in solid tumors globally — which assessed the efficacy and safety of satri-cel compared with the treatment of physician's choice — satri-cel treatment resulted in a significant improvement in progression-free survival, with a manageable safety profile. In the intention-to-treat population, the median progression free survival was 3.25 months in the satri-cel group and 1.77 months in the treatment of physician's choice group. Satri-cel reduced the risk for progression or death by 63%.
The results support satri-cel as a new third-line treatment for advanced gastric or gastro-oesophageal junction cancer patients.
Satri-cel is an autologous CAR-T cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer and pancreatic cancer.
“This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures," said Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of the study.
The results were shared at ASCO and published in The Lancet.
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