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The first randomised trial of CAR-T cells in a solid tumour: in heavily pretreated Claudin 18.2-positive stomach cancer, satri-cel held the disease for a median of 3.25 months against 1.77 months on the doctor's choice of drug, with almost universal cytokine release syndrome.
Open-label, multicentre, randomised controlled phase 2 trial in China in patients with CLDN18.2-positive (immunohistochemistry intensity at least 2+ and at least 40 percent positive tumour cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two previous lines. Patients were randomly allocated 2:1 to satri-cel (up to three infusions of 250 million cells) or treatment of physician's choice (nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib), with crossover to satri-cel allowed after progression or intolerance. The primary endpoint was progression-free survival by independent review committee in the intention-to-treat population.
Between March 2022 and July 2024, 266 patients were screened and 156 randomised (104 satri-cel, 52 physician's choice); 88 (85 percent) and 48 (92 percent) received study drug. Median progression-free survival was 3.25 months (95% CI 2.86 to 4.53) with satri-cel and 1.77 months (95% CI 1.61 to 2.04) with physician's choice (hazard ratio 0.37, 95% CI 0.24 to 0.56; one-sided log-rank p<0.0001). Grade 3 or higher treatment-emergent adverse events occurred in 87 of 88 (99 percent) treated satri-cel patients and 30 of 48 (63 percent) on physician's choice; cytokine release syndrome occurred in 84 of 88 (95 percent). Funded by CARsgen Therapeutics.
This is the trial behind the first approval of a CAR-T therapy for a solid tumour, in China. The gain in progression-free survival is real but measured in weeks, 15 percent of patients randomised to satri-cel never received it, and nearly every treated patient had cytokine release syndrome, so the trade-off is very different from CAR-T in blood cancers. Overall survival is not reported in the abstract.
Shares CARsgen Therapeutics, Satricabtagene autoleucel, Claudin 18.2, CAR-T cell therapy and the tag china.
Shares CARsgen Therapeutics, Satricabtagene autoleucel, CAR-T cell therapy, Gastric & gastro-oesophageal junction cancer and the tag china.
Shares CARsgen Therapeutics, CAR-T cell therapy and the tag china.
Shares Peking University Cancer Hospital and the tag china.
Shares CARsgen Therapeutics, CAR-T cell therapy and the tag china.
Shares Gastric & gastro-oesophageal junction cancer and the tag china.
Shares CAR-T cell therapy and the tag china.
Shares Gastric & gastro-oesophageal junction cancer and the tag china.