FDA Approves Kimmtrak for Unresectable or Metastatic Uveal Melanoma

The Food and Drug Administration (FDA) has approved Kimmtrak (tebentafusp-tebn) for the treatment of patients of unresectable or metastatic uveal melanoma who are HLA-A*02:01 positive.

This marks the first and only therapy approved by the FDA for unresectable or metastatic uveal melanoma, according to a press release from Immunocore, the drug’s manufacturer. In addition, Kimmtrak is the first T-cell receptor therapeutic to be approved by a regulatory body.

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said Dr. John Kirkwood, director of the Melanoma Center at the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania, in the release. “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.”

The FDA approval of Kimmtrak was based on findings from the phase 3 IMCgp100-202 trial, in which researchers enrolled patients with previously untreated metastatic uveal melanoma. In this trial, 378 patients were randomly assigned either Kimmtrak or investigator’s choice of treatment (Yervoy [ipilimumab], Keytruda [pembrolizumab] or dacarbazine). Patients treated with first-line Kimmtrak had obtained an overall survival (percentage of patient who are still alive after treatment) benefit compared with investigator’s choice.

“Today’s approval of Kimmtrak is a historic milestone and the culmination of years of dedication by the Immunocore team, patients and our health care partners,” said Bahija Jallal, chief executive officer of Immunocore, in the release. “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, and we are focused on making Kimmtrak available as quickly as possible.”

Severe side effects related to treatment observed in the trial were manageable and included fever (4%), rash (18%) and itching (5%). Severe cytokine release syndrome (an acute systemic inflammatory syndrome associated with fever and multiple organ dysfunction) occurred in less than 1% of patients and was generally well managed, according to the release. No life-threatening or fatal events related to cytokine release syndrome occurred in this trial. A boxed warning has been included for Kimmtrak indicating cytokine release syndrome and how it can be life threatening if not managed properly.

“Until now, effective treatment options for metastatic uveal melanoma patients were virtually nonexistant,” said Kyleigh LiPira, chief executive officer of the Melanoma Research Foundation, in the release. “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.”

The release noted that Immunocore is ready to commercialize Kimmtrak and plans to make it commercially available in the U.S. in the next few weeks.

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