Biotechnology company CARsgen Therapeutics Holdings Limited (HK:2171) announced on Monday positive results from its pivotal Phase II clinical trial CT041-ST-01 (NCT04581473).

The trial evaluated satricabtagene autoleucel (satri-cel, CT041), an autologous CAR T-cell therapy targeting Claudin18.2, in advanced gastric and gastroesophageal junction cancer patients who had failed at least two prior therapies. Subjects were randomized 2:1 to receive either satri-cel infusion or physician-selected treatments, including paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab.

Progression-free survival (PFS), the trial's primary endpoint assessed by the Independent Review Committee, showed statistically significant improvement in the satri-cel group. The safety profile of satricabtagene autoleucel was consistent with previous findings and considered manageable. These results highlight satri-cel's potential as a therapeutic option for heavily pretreated patients.