CARsgen's Satri-cel Shows Durable Survival Benefit in Advanced Gastric Cancer with 4.5-Year Follow-up
核心洞察
CARsgen's satri-cel CAR T-cell therapy achieved 100% objective response rate in patients with advanced gastric cancer (搜索) when used sequentially after first-line treatment, with median follow-up exceeding 4.5 years.
The therapy demonstrated median progression-free survival of 20.9 months from initial first-line therapy, with two patients undergoing successful surgical resection after treatment.
Safety profile remained favorable with no grade 3 or higher cytokine release syndrome, no neurotoxicity, and no treatment-related deaths reported.
CARsgen Therapeutics (搜索) has presented compelling long-term follow-up data for satricabtagene autoleucel (satri-cel), demonstrating sustained efficacy in patients with advanced gastric cancer (搜索) when administered sequentially after first-line therapy. The results, presented at the 2026 ASCO Annual Meeting, represent the longest follow-up data available for a CAR T-cell therapy targeting Claudin18.2 (搜索) in solid tumors.
Exceptional Response Rates in High-Risk Patient Population
The investigator-initiated trial CT041-CG4006 (NCT03874897) evaluated satri-cel in five patients with Claudin18.2 (搜索)-positive gastric/gastroesophageal junction cancer who received the therapy at a dose of 2.50×10⁸ cells following first-line treatment. The patient population presented particularly challenging characteristics, with 60% having Lauren diffuse type tumors, 80% presenting with signet ring cell carcinoma (搜索), and 80% having peritoneal metastases—features generally associated with extremely poor survival prognosis.
Among the four patients with target lesions, the confirmed objective response rate reached 100%, with the median duration of response not yet reached after more than 4.5 years of follow-up. The single patient without target lesions maintained stable disease for 20.9 months. These results are particularly noteworthy given that only one patient achieved partial response after first-line chemotherapy, indicating poor efficacy of conventional treatment in this cohort.
Sustained Survival Benefits and Surgical Opportunities
As of the October 18, 2025 data cutoff, the median follow-up from initial first-line therapy was 54.6 months. The median progression-free survival since first-line therapy reached 20.9 months across all five patients. Remarkably, two patients experienced such significant clinical benefit that they became candidates for surgical resection following satri-cel therapy. Both patients remained alive at the data cutoff, with follow-up durations of 58.1 months and 51.1 months, respectively.
Favorable Safety Profile Maintained Long-term
The safety analysis revealed no grade 3 or higher cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, and no treatment-related deaths. Additionally, no grade ≥3 infections or febrile neutropenia were reported throughout the extended follow-up period.
Regulatory Progress and Clinical Development
Satri-cel represents a potentially first-in-class autologous CAR T-cell therapy targeting Claudin18.2 (搜索), with primary focus on gastric/gastroesophageal junction adenocarcinoma (搜索) and pancreatic cancer (搜索). The Center for Drug Evaluation of China's National Medical Products Administration accepted the New Drug Application for satri-cel on June 25, 2025, for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy.
The therapy has received Priority Review designation in May 2025 and Breakthrough Therapy Designation in March 2025 from Chinese regulators. CARsgen is actively expanding satri-cel's application to earlier treatment lines and perioperative settings, with ongoing Phase I trials for pancreatic cancer (搜索) adjuvant therapy and investigator-initiated trials for consolidation and sequential therapy in gastric cancer (搜索) patients.
Implications for Solid Tumor CAR T-cell Therapy
The sustained efficacy demonstrated over 4.5 years of follow-up represents a significant milestone for CAR T-cell therapy in solid tumors, a field that has faced considerable challenges compared to hematologic malignancies. The ability to convert patients to surgical candidates and maintain long-term disease control suggests potential for meaningful clinical impact in a disease with historically poor outcomes.