The U.S. Food and Drug Administration approved a T-cell receptor therapy, KIMMTRAK®, for unresectable or metastatic uveal melanoma. KIMMTRAK is the brand name for tebentafusp-tebn.
“Unresectable” means the melanoma tumor can’t be removed with surgery. “Metastatic” means the cancer has spread beyond the localized area where it formed.
Immunocore, the developer and manufacturer of KIMMTRAK, announced the news on Wednesday, January 26, via press release.
“Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options.” — Bahija Jallal, Chief Executive Officer of Immunocore
The approval is further proof of the promise of cancer cell and gene therapy. As more novel treatments emerge for different types of cancer, more patients gain options they otherwise wouldn’t have. This approval is another monumental step forward in saving lives and affirms the vital work of Alliance for Cancer Gene Therapy in funding cell and gene research that advances new treatments for solid tumors.
Historic news for treatment of solid tumors
This news is historic for multiple reasons. KIMMTRAK is the first treatment approved for this rare skin cancer. Uveal melanoma is a cancer within the eye, more specifically in the uvea. This area is beneath the cornea and includes the iris. There are approximately 2,500 people diagnosed with uveal melanoma in the United States each year.
The second historic aspect is that KIMMTRAK is the first T-cell receptor (TCR) therapy approved by the FDA. This immunotherapy enhances T-cell receptors to target cancerous melanocyte cells in the uvea. TCR therapy is also called engineered T-cell receptors or T-cell receptor-engineered T cells (TCR-T cells).
Five CAR T-cell therapies already have approval for specific types of leukemia, lymphoma and multiple myeloma. KIMMTRAK is now the sixth cell and gene therapy approved for any type of cancer – and the first for a solid tumor.
KIMMTRAK enhances T-cell receptors by looking for a human leukocyte antigen (HLA). This antigen presents fragments of cancerous protein (peptides) on the surface of cells. T cells differentiate healthy cells from cancerous melanoma cells thanks to KIMMTRAK.
Phase 3 clinical trial leads to approval
The FDA approval comes on the heels of a Phase 3 trial using KIMMTRAK for uveal melanoma. The engineered TCR therapy led to excellent survival results compared to other therapies, including immunotherapy drugs pembrolizumab and ipilimumab.
“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients. The approval of KIMMTRAK represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.” — John Kirkwood, MD, Director of University of Pittsburgh Medical Center’s Melanoma Center
Engineered TCRs and CAR T-cell therapies are just two types of cancer cell and gene therapies now approved by the FDA and other international regulatory agencies. Trailblazing research at the top cancer hospitals could lead to more FDA approvals for the treatment of solid tumors.
- Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma. Immunocore. Retrieved from: https://ir.immunocore.com/news-releases/news-release-details/immunocore-announces-fda-approval-kimmtrakr-tebentafusp-tebn/. Accessed: 01/27/2022.
- Abstract 2271: Tebentafusp recognition of melanoma cells is restricted by HLA-A0201 presentation of a gp100 peptide. American Association for Cancer Research. Retrieved from: https://cancerres.aacrjournals.org/content/80/16_Supplement/2271. Accessed: 01/27/2022.