China’s National Medical Products Administration has approved the world’s first CAR T-cell therapy for a solid tumour.
It is called satri-cel, (satricabtagene autoleucel)
The therapy is approved for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer who have already received at least two prior lines of treatment.
The excitement surrounding this approval comes from a major limitation of CAR-T therapy. Until now, approved CAR-T products had been restricted to blood cancers.
But for solid tumours, the CAR-T cell has to:
- travel into the tumor
- penetrate densely packed tissue
- survive an immunosuppressive microenvironment and distinguish cancer cells from surrounding healthy tissue.
Image via Nature (https://www.nature.com/articles/s41571-023-00832-4)
CARsgen addresses these challenges by developing a specialized preconditioning regimen.
In addition to conventional cyclophosphamide and fludarabine lymphodepletion, patients receive low-dose nab-paclitaxel
This is intended to improve the infiltration and antitumor activity of the CAR-T cells within the tumor.
Targeting Claudin18.2 is also a strategic move:
It’s a protein with highly restricted expression in healthy tissues but elevated expression in gastric cancer and several other solid tumors. This gives the engineered T cells a comparatively more selective marker.
Although,
Satri-cel does not mean that CAR-T therapy has overcome every challenge associated with solid tumors.
Its approval applies to a specific biomarker-defined group of patients with advanced gastric cancer.
But
It provides the first regulatory proof that CAR-T therapy can move beyond blood cancers and successfully enter the treatment landscape for solid tumors.
The solid-tumor barrier has not disappeared, but the first opening has been made.
If you’re interested in developing CAR-T therapies, we provide comprehensive solutions for CAR-T cell therapy development
from early target discovery to preclinical phase of research and development.
Check us out at: https://www.sinobiological.com/category/car-t-cell-immunotherapy
Adapted from: https://ow.ly/64EX50ZfUZJ
