By Fineline Cube 
China-based CARsgen Therapeutics Holdings Limited (HKG: 2171) announced that it has published an abstract of the research results of the confirmatory Phase II study for satricabtagene autoleucel (satri-cel, CT041), an autologous CAR T-cell product candidate against protein Claudin18.2, in advanced gastric/gastroesophageal junction cancer (G/GEJC) in China on the American Society of Clinical Oncology (ASCO) website.
Study Results
In the ITT population (i.e., all randomized patients), the satri-cel arm showed significant improvement in median progression-free survival (mPFS) by Independent Review Committee (IRC) (3.25 months vs 1.77 months; HR 0.366, 95% CI: 0.241, 0.557; p < 0.0001), meeting the primary endpoint with a 63% reduction in risk of disease progression or death. Even with 15.4% (n=16) of patients in the satri-cel arm failing to receive infusion and nearly 40% (n=20) of patients in the TPC arm receiving subsequent satri-cel, the satri-cel arm still demonstrated a clear trend toward overall survival (OS) benefit (mOS 7.92 months vs 5.49 months; HR 0.693, 95% CI: 0.457, 1.051; one-sided p = 0.0416), showing over 30% reduction in mortality risk.
Modified ITT Population
More importantly, in the mITT population (i.e., patients who were actually treated), 136 patients received the study drug (satri-cel 88 patients vs TPC 48 patients). The mPFS by IRC was 4.37 months vs 1.84 months, HR 0.304 (95% CI: 0.195, 0.474), representing a 70% reduction in risk of disease progression or death. The mOS was 8.61 months vs 5.49 months, HR 0.601 (95% CI: 0.385, 0.939), corresponding to a 40% reduction in mortality risk. These results demonstrate that satri-cel treatment benefits were pronounced in patients who actually received CAR-T infusion.
Regulatory Designations
Satri-cel was awarded Breakthrough Therapy Designation by the Center for Drug Evaluation of NMPA for the treatment of Claudin18.2-positive advanced G/GEJC in patients who have failed at least two prior lines of therapy in March 2025. It also obtained Regenerative Medicine Advanced Therapy designation and Orphan Drug designation from the U.S. FDA for the treatment of advanced G/GEJC with Claudin18.2-positive tumors in January 2022 and for the treatment of G/GEJC in September 2020, respectively.-Fineline Info & Tech