Solid cancer CAR-T arrives: world first approval to CARsgen

CAR-T cell therapy, reprogramming a patient's own immune cells as a living drug to fight cancer, have transformed outcomes for blood cancer patients since first approvals in 2017. Bringing that same hope to the many more patients with solid cancers is the goal of many company, including AdAlta through its "East to West" cell therapy strategy.

Today AdAlta congratulates CARsgen Therapeutics on the approval of Satri-cel in China. Satri-cel is the world’s first CAR-T cell therapy product approved for the treatment of solid tumors, in this case for Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. In the clinical study supporting Satri-cel's approval , tumour shrinkage (overall response rate) was just 4% in the control arm but was more than 20% in patients who received Satri-cel, including patients who switched to Satri-cel from the control arm at the end of the study. Median time to disease progression almost doubled in the Satri-cel arm. These are significant outcomes for patients otherwise facing five year survival rates of less than 10%.

This approval is significant validation of AdAlta's belief that CAR-T cells can be effective in solid cancers and that China is leading global source of innovation in this field. The approval builds on two prior US approvals for non-CAR-T engineered T cell therapies, Tecelera (a TCR-T cell product for synovial sarcoma) and Amtgavi (a tumour infiltrating lymphocyte product for advanced melanoma).

AdAlta's lead CAR-T product, BZDS1901 being co-developed with Shanghai Cell Therapy Group, targets a different tumour antigen, mesothelin (MSLN), and is being developed first in advanced mesothelioma, a cancer with similar poor prognosis to G/GEJA. BZDS1901 has additional engineering to help it overcome tumour immune system suppression and in early clinical studies in China has similarly demonstrated tumour shrinkage (overall response rates) at least double current treatment options including complete tumour clearance in up to 20% of patients, a result very rarely, if ever, seen with existing treatment options. BZDS1901 is being transferred to an Australian manufacturing location in preparation for further clinical trials.