CARsgen Nabs Chinese Approval of Satri-cel, its CAR-T Therapy for Stomach Cancer
Based on the RCT results published in The Lancet, the Chinese biotech company has received approval for the world's first CAR-T for solid tumors.
Key Points
- CARsgen has received NMPA approval for satri-cel to treat Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy.
- Satri-cel is an autologous (sourced from the patient) CAR T-cell therapy targeting Claudin18.2, and the company says it is the first approved CAR T-cell therapy for solid tumors.
- Published Phase 2 data in The Lancet supported the approval, with the company reporting efficacy and a manageable safety profile in heavily pretreated patients.
CARsgen, a Chinese biotech company, has received NMPA (China’s FDA) approval for satri-cel, its autologous CAR-T cell therapy for gastric cancer, specifically Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma, in patients who have failed at least two prior lines of therapy.
Gastric cancer remains a high-burden disease globally and in China, where a large share of cases are diagnosed at advanced stages. Earlier diagnosis rates remain low, and long-term survival for advanced disease is poor, underscoring the unmet need in later-line treatment.
The approval provides a new cell therapy option for a disease area with limited treatment choices after multiple prior regimens. The company says satri-cel is the first approved CAR T-cell therapy for solid tumors.
How satri-cel works
Satri-cel is an autologous (sourced from the patient) CAR T-cell therapy directed against Claudin18.2, a protein the release describes as highly expressed in gastric cancer and other malignant tumors, with limited expression in normal healthy tissues.
According to the company, the CAR construct includes:
- A humanized Claudin18.2-specific single-chain monoclonal antibody fragment called hu8E5-2I
- A CD8α hinge region
- A CD28 transmembrane region
- A CD28 intracellular signaling domain
- A CD3ζ intracellular signaling region
CARsgen also says it developed a preconditioning regimen to support treatment in solid tumors. This regimen adds low-dose nab-paclitaxel to a conventional lymphodepletion backbone of cyclophosphamide and fludarabine, with the goal of improving CAR T-cell infiltration and anti-tumor activity in the tumor microenvironment.
Clinical data and next steps
Beyond the approved indication, satri-cel is being studied in earlier-line and perioperative settings. Ongoing programs include:
- A Phase I trial in China for pancreatic cancer adjuvant therapy
- An investigator-initiated trial for consolidation treatment after adjuvant therapy in resected G/GEJA
- An investigator-initiated trial for sequential therapy after first-line treatment for G/GEJA
The approval was supported by a confirmatory RCT published in The Lancet. In that, satri-cel reported meaningful efficacy and a good safety profile compared with existing treatment options in heavily pretreated patients with advanced gastric or gastroesophageal junction cancer.
Professor Lin Shen’s team at Peking University Cancer Hospital led the clinical studies of satri-cel. Professor Shen commented, “The approval of satri-cel provides us with a novel and effective therapeutic weapon. This product has brought clinically meaningful and significant benefits to such patients, with remarkable efficacy that is difficult to achieve with existing treatment modalities. More importantly, as a CAR-T product, satri-cel offers patients the opportunity to break free from the constraints of frequent hospital visits for treatment, achieving a leap from ‘prolonging survival’ to ‘improving quality of life.’ As the world’s first successfully marketed CAR-T therapy for solid tumors, satri-cel not only fills the gap in later-line treatment for advanced gastric cancer but also ushers in a new era of cellular therapy for solid tumors. This breakthrough lays a critical foundation for advancing frontline therapy and combination treatment strategies, and is expected to reshape the treatment landscape of gastric cancer and even gastrointestinal tumors. We believe that with the promotion of clinical application, this innovative therapy will illuminate new hope for life for the vast number of gastric cancer patients.”
Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, stated, “The approval and launch of satri-cel is an important milestone event marking the advancement of CAR-T cell therapy from hematologic malignancies to solid tumors. This would not have been possible without the trust and support of the patients and their families who participated in the clinical trials, the investigator teams, partners, regulatory agencies, and relevant departments. We will go all out to advance the clinical application and market access of satri-cel, ensuring that this innovative therapy benefits Chinese patients widely and in a timely manner. At the same time, we will strive to expand this product to more countries and regions to meet greater medical needs. In addition, we are also exploring first-line sequential therapy and postoperative adjuvant therapy for advanced gastric cancer, with the aim of helping more patients achieve deeper therapeutic benefits and even the possibility of cure.”
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