cancer drug

The First FDA Approval TCR Drug for Eye Cancer

The Food and Drug Administration approved the first drug used as treatment for uveal melanoma (UM), an aggressive skin cancer that occurs in the eye tissue. The drug, Kimmtrak®, was developed by Immunocore Holdings, and it is the first and only T cell receptor (TCR) therapeutic drug to receive regulatory approval on the market.

Uveal melanoma is a common primary intraocular tumor in adults.


The clinical treatments for UM involve both radiation therapy and enucleation. Enucleation is another alternative therapy for large tumors or tumors involving the optic nerve. Regardless of the fact that the disease has been controlled, the long-term survival rate of patients remains guarded as there is a risk for metastasis. 




Kimmtrak is a novel bi-specific protein consisting of a soluble affinity-enhanced T cell receptor and an anti-CD3 effector. The soluble affinity-enhanced T cell receptor part can specifically target gp100, a lineage antigen expressed in melanoma; another part of the anti-CD3 effector can recruit and activate T cells to kill tumor cells.


Phase three of using Kimmtrak in the clinical trial was published in the New England Journal of Medicine. Data showed that there was a 73% overall survival rate (OS) for patients that had received the Kimmtrak treatment compared to the 59% OS for patients who received other kinds of drugs. Kimmtrak demonstrated a significant increase in the median of OS.


CAR-T cell therapy has advantages in the treatment of hematological tumors; nonetheless, this treatment is limited to solid tumors. On the other hand, TCR-based therapy is more effective in treating solid tumors; therefore, it is prospectively being studied and developed, and it may potentially become a next-generation strategy for cancer treatment.




  1. Global Bio & Investment: 
  2. GeneOnline: 
  3. Immunocore News Release: 
  4. Paul Nathan, et al., Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. NEJM. 2021: