NEW YORK – Carsgen Therapeutics on Monday said it plans to seek approval in China for its autologous CAR T-cell therapy satricabtagene autoleucel (satri-cel) in previously treated patients with Claudin 18.2 expression-positive advanced gastric or gastroesophageal junction cancers.
The firm said the Phase III trial of satri-cel met its primary endpoint demonstrating a statistically significant improvement in progression-free survival compared to physician's choice of treatment with chemotherapy paclitaxel or docetaxel, topoisomerase I inhibitor irinotecan, VEGFR-2-targeted tyrosine kinase inhibitor apatinib, or Bristol Myers Squibb's immunotherapy Opdivo (nivolumab).
Carsgen expects to submit a new drug application for satri-cel to China's National Medical Products Administration in the first half of 2025.
The Shanghai-based company is also studying satri-cel in the adjuvant setting for Claudin 18.2-expressing gastric and gastroesophageal cancer and Claudin 18.2-expressing pancreatic cancer.
Earlier this year, the US Food and Drug Administration lifted clinical holds on US trials of three of Carsgen's CAR T-cell therapies, including satri-cel, after halting the studies due to findings during an inspection of the company's manufacturing site in Durham, North Carolina.