On January 25, 2022, the FDA accelerated the approval of Kimmtrak (tebentafusp-tebn; from Immunocore), a novel type of immunotherapy called bispecific gp100 peptide-HLA–directed CD3 T-cell engager, for the treatment of adults with HLA-A*02:01 unresectable or metastatic (spreading) uveal (intraocular, or inside the eye) melanoma, a rare and aggressive type of melanoma that affects the eye. Kimmtrak is the first T-cell receptor approved by the FDA, and the first drug ever to be approved for uveal melanoma.
“Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma, who, until now, had no approved treatment options. Kimmtrak is the first therapy to demonstrate a survival benefit to patients with this disease,” said Bahija Jallal, Immonocore’s Chief Executive Officer.
“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients. The approval of tebentafusp-tebn [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,” said John Kirkwood, MD, Director of the Melanoma Center at the UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania.
“Until now, effective treatment options for metastatic uveal melanoma patients were virtually non-existent. The approval of Kimmtrak represents not only a new therapy but a new hope for the individuals and the families of those diagnosed with the deadliest form of eye cancer,” said Kyleigh LiPira, MBA, CEO of the Melanoma Research Foundation.
The approval of Kimmtrak was based on the results of a clinical trial of 378 patients with metastatic uveal melanoma. Patients were divided into 2 groups, with 252 patients receiving Kimmtrak and 126 patients receiving the investigator’s choice of 1 of 3 drugs approved for melanoma, including the immunotherapy Keytruda (pembrolizumab) or Yervoy (ipilimumab), or the chemotherapy dacarbazine.
The average time of survival was 21.7 months in patients who received Kimmtrak compared with only 16 months in patients who received the investigator’s choice of immunotherapy or chemotherapy, a significant difference of more than 5 months.
The most common side effects reported with Kimmtrak were cytokine-release syndrome (a serious side effect seen with immunotherapy), rash, fever, pruritus, fatigue, nausea, chills, stomach pain, edema, hypotension, dry skin, headache, and vomiting.