China has approved satricabtagene autoleucel (satri-cel), making it the first CAR T-cell therapy in the world approved for the treatment of solid tumors. The therapy is intended for patients with CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer whose disease has progressed after at least two previous treatments.
The approval is based on results from a Phase 2 trial that compared satri-cel with standard treatment options selected by physicians. Patients receiving satri-cel experienced significantly longer progression-free survival, with a median of 3.25 months compared with 1.77 months in the control group. Because satri-cel is given as a one-time or limited infusion, it may also reduce the need for frequent hospital visits associated with ongoing chemotherapy.
However, the treatment was associated with substantial side effects. Severe treatment-related adverse events occurred in 99% of patients receiving satri-cel, compared with 63% in the control group. Common severe side effects included low lymphocyte, white blood cell, and neutrophil counts. In addition, 95% of patients experienced cytokine release syndrome, a common immune-related reaction seen with CAR T-cell therapies.