Immunotherapy becomes first FDA-approved treatment for rare type of melanoma

Feb 01, 2022
Devin Golden

KIMMTRAK becomes first T-cell therapy approved for a solid tumor cancer.

The U.S. Food and Drug Administration approved a unique type of immunotherapy, 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

As more novel treatments emerge for different types of cancer, more patients gain options they otherwise wouldn’t have.

Historic news for treatment of solid tumors 

This news is historic as 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.

This immunotherapy helps T cells target cancerous melanocyte cells in the uvea. KIMMTRAK is called a T-cell engager therapy, which binds the T cells to cancer cells.

Six CAR T-cell therapies have approval for specific types of leukemia, lymphoma and multiple myeloma. KIMMTRAK makes seven cell and gene therapies approved for any type of cancer – and the first for a solid tumor. 

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 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

Trailblazing research at the top cancer hospitals could lead to more FDA approvals for the treatment of solid tumors. 

Alliance for Cancer Gene Therapy is a leader in funding research initiatives into new avenues for treatment using cell and gene therapy for cancer. With your donation to ACGT, this goal is possible.

Page sources

  1. Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma. Immunocore. Retrieved from: Accessed: 01/27/2022.
  2. Abstract 2271: Tebentafusp recognition of melanoma cells is restricted by HLA-A0201 presentation of a gp100 peptide. American Association for Cancer Research. Retrieved from: Accessed: 01/27/2022.