China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced positive results from its pivotal Phase II CT041-ST-01 study for satricabtagene autoleucel, a chimeric antigen receptor (CAR) T-cell therapy. The study, which is randomized, controlled, and multi-center, aims to evaluate the efficacy and safety of the therapy in patients with CLDN18.2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) in at least the third-line treatment setting.
Satricabtagene Autoleucel Meets Primary Endpoint for Progression-Free Survival
The primary endpoint of the study, progression-free survival (PFS) as evaluated by the Independent Review Committee (IRC), was successfully met. Satricabtagene autoleucel demonstrated a significant and statistically improved PFS in the patients treated. This achievement underscores the potential of the therapy in improving outcomes for patients with advanced GC/GEJ.
Safety Profile of Satricabtagene Autoleucel
Previous study results have also shown that the safety profile of satricabtagene autoleucel is controllable, adding to the growing body of evidence supporting its potential as a viable treatment option for patients with CLDN18.2-expressing tumors.
Market Filing Plans for Satricabtagene Autoleucel
Satricabtagene autoleucel, a potential first-in-class CAR-T cell therapy targeting CLDN18.2, is on track for market filing in China during the first half of 2025. This milestone marks an important step towards making this innovative therapy accessible to patients in need.-Fineline Info & Tech
