CARsgen wins first global approval of CAR T therapy for solid tumours

Now approved in China, CARsgen Therapeutics’ satricabtagene autoleucel (satri-cel) is the first CAR T therapy to secure global approval in a solid tumour, setting a new standard for this form of treatment.

The autologous treatment is indicated for Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in those who have failed at least two prior lines of therapy.

Dr Zonghai Li’s Chief Executive Officer and Chief Scientific Officer of CARsgen, explained that approval of satri-cel represents an important milestone “marking the advancement of CAR T-cell therapy from hematologic malignancies to solid tumours”.

According to CARsgen, it lays the foundation “for advancing to earlier lines of therapy, exploring combination treatment regimens, and expanding applications to other Claudin18.2-positive solid tumours such as pancreatic cancer and biliary tract cancer”.

Prior to infusion with satri-cel, patients are treated with a preconditioning regimen comprising of low-dose nab-paclitaxel as well as cyclophosphamide and fludarabine to enhance the infiltration and anti-tumour efficacy of CAR T cells.

Satri-cel has demonstrated significant efficacy benefit and a good safety profile compared to existing treatments in advanced, heavily pretreated G/GEJ cancer. The results from the confirmatory study were published in The Lancet.

Professor Lin Shen, Peking University Cancer Hospital, commented: “For patients with advanced G/GEJA who have failed multiple lines of prior therapy, previous treatment options were extremely limited and the prognosis was very poor. 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 tumours, 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 tumours.

“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 tumours. 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.”

“As the world’s first successfully marketed CAR-T therapy for solid tumours, 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 tumours”

Professor Lin Shen, Peking University Cancer Hospital

 

Earlier this year, AstraZeneca gained positive opinion from the CHMP for Imfinzi plus chemotherapy as a gastric cancer treatment. If approved, the regimen would become the first immunotherapy-based perioperative therapy for adults with early gastric and gastroesophageal cancers in Europe.