Long-term Follow-up Results of CARsgen's Satri-cel as Sequential Therapy After First-Line Treatment for Gastric Cancer Presented at the 2026 ASCO Annual Meeting

CARsgen Therapeutics announced long-term results of its CAR T-cell therapy satri-cel (CT041) for advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) at the 2026 ASCO Annual Meeting. The study, an open-label phase 1 trial (NCT03874897), followed five patients with Claudin18.2-positive tumors who received satri-cel after failing first-line chemotherapy. Despite poor initial responses—only one patient showed partial remission—the therapy achieved a 100% confirmed objective response rate (ORR) among the four patients with measurable lesions, with a median progression-free survival (PFS) of 20.9 months from first-line treatment. The trial included patients with aggressive cancer subtypes: 60% had Lauren diffuse-type tumors, 80% had signet ring cell carcinoma, and 80% had peritoneal metastases, all linked to poor prognoses. After satri-cel infusion, two patients underwent successful surgical resection and remained alive at 58.1 and 51.1 months of follow-up. Safety data showed no grade 3+ cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or treatment-related deaths, with no severe infections or febrile neutropenia reported. Satri-cel targets Claudin18.2, a protein overexpressed in gastric and pancreatic cancers, making it a first-in-class candidate. The therapy’s long-term durability—with a median follow-up exceeding 4.5 years—supports its potential for earlier treatment lines. China’s National Medical Products Administration (NMPA) has accepted satri-cel’s New Drug Application (NDA) for Claudin18.2-positive advanced G/GEJA in patients who failed at least two prior therapies, granting it Priority Review in May 2025 and Breakthrough Therapy Designation in March 2025. CARsgen is expanding satri-cel’s use for earlier-line and perioperative treatments, aiming to address unmet needs in gastric cancer. The 2026 ASCO presentation underscored its clinical value, particularly for high-risk patient subgroups with limited treatment options.