CARSgen bags world-first approval for solid tumour CAR-T

CARSgen Therapeutics has claimed approval in China, its home market, for satricabtagene autoleucel (satri-cel), said to be the first CAR-T therapy to be approved anywhere in the world to treat a solid tumour.

China's National Medical Products Administration (NMPA) has cleared the claudin 18.2-targeting autologous CAR-T for the treatment of patients with claudin 18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction (GEJ) adenocarcinoma who have failed at least two prior lines of therapy.

CAR-T therapies have transformed the treatment of various blood cancers, but have been less effective for solid tumours, in part because they find it difficult to target cancer cells, as well as infiltrate and survive in the hostile microenvironment of the tumour.

The NMPA approval is based on a phase 2 trial, published in The Lancet, which revealed a significant improvement in progression-free survival, achieving a median PFS of 3.25 months compared to 1.77 months for the standard-of-care control arm, with a manageable safety profile, in heavily pre-treated claudin 18.2-positive gastric and GEJ cancer.

CARSgen has expanded its clinical trials in China to include earlier-line treatment of gastric and GEJ cancers, including adjuvant use in earlier-stage disease, and is also looking at its potential in pancreatic, biliary tract, and other cancers expressing the biomarker.

Internationally, meanwhile, it is running phase 1/2 trials of the CAR-T, and has previously picked up FDA orphan drug and regenerative medicine advanced therapy (RMAT) designations. In 2023, CARSgen also teamed up with Moderna to look at combining satri-cel with Moderna's investigational claudin 18.2 mRNA cancer vaccine, although there has been no update from the partners since.

Gastric cancer is one of the most common cancers worldwide, ranking fifth in both incidence and mortality globally, with approximately 970,000 new cases and 660,000 deaths annually.

More than 70% of new and fatal cases occur in Asia, according to CARSgen, and Chinese patients account for approximately 47% of the global gastric cancer burden. In around 80% of cases the cancer is not detected until it has progressed to advanced disease.

"For patients…who have failed multiple lines of prior therapy, previous treatment options were extremely limited and the prognosis was very poor," said Prof Lin Shen of Peking University Cancer Hospital, who led the pivotal satri-cel study. "The approval of satri-cel provides us with a novel and effective therapeutic weapon."

The approval is also a further endorsement of the role of claudin 18.2 in cancer treatment, coming after regulators approved Astellas' antibody-based therapy Vyloy (zolbetuximab) as the first therapy directed at the target in 2024.

Shares in Hong Kong-listed CARSgen were trading up 7% at the time of writing.