CARsgen Announces Approval of Satri-cel, the World's First CAR T-Cell Therapy Product for Solid Tumors
CARsgen Therapeutics Holdings Limited, a company focused on developing innovative CAR T-cell therapies, announced that the National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for satricabtagene autoleucel (satri-cel). This proprietary autologous humanized Claudin18.2 CAR T-cell therapy is designated for treating patients with Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. Satri-cel is recognized as the world’s first approved CAR T-cell therapy product targeting solid tumors.
Gastric cancer has a significant global impact, ranking fifth in incidence and mortality, with about 970,000 new cases and 660,000 deaths each year. More than 70% of new cases and fatalities occur in Asia, with Chinese patients representing approximately 47% of the global burden. In 2022, there were around 360,000 new gastric cancer cases and 260,000 deaths in China, marking it as the fifth highest in cancer incidence and third in mortality. Early diagnosis remains low, with fewer than 20% diagnosed at early stages, leading to a bleak 5-year survival rate of about 10% for advanced cases.
Claudin18.2 is a selective marker protein that is minimally expressed in healthy tissues but is prevalent in gastric cancer and other malignancies. Satri-cel functions as an autologous CAR-T cell product specifically targeting Claudin18.2. It contains a genetically modified CAR construct designed to enhance the therapeutic efficacy of CAR T cells. To address treatment challenges in solid tumors, the company developed an innovative preconditioning regimen incorporating low-dose nab-paclitaxel alongside conventional lymphodepletion measures.
Clinical efficacy for satri-cel has been documented in leading medical journals, with significant results published in The Lancet. The therapy showed promising benefits in heavily pretreated G/GEJ cancer patients with limited options and poor prognoses, marking a new standard for CAR T therapy in solid tumors. This breakthrough is anticipated to expand applications to other Claudin18.2-positive solid tumors and improve treatment strategies for gastric cancer.
Professor Lin Shen from Peking University Cancer Hospital, who led the clinical studies, emphasized that satri-cel offers new hope for patients with advanced G/GEJA after they have exhausted multiple treatment options. Dr. Zonghai Li, the founder and CEO of CARsgen, highlighted the approval as a crucial milestone for CAR-T cell therapy extending beyond hematologic malignancies to include solid tumors. The company plans to advance the clinical application and availability of satri-cel both in China and globally, while exploring first-line sequential therapy options for advanced gastric cancer.