FDA Approves KIMMTRAK (tebentafusp-tebn) for the Treatment of Unresectable or Metastatic Uveal Melanoma


January 26, 2022 (Richmond, California) Earlier today, Immunocore announced that the U.S. Food and Drug Administration (FDA) has approved KIMMTRAK (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic Uveal Melanoma. KIMMTRAK is the first and only FDA approved therapy for the treatment of unresectable or metastatic uveal melanoma (mUM).

FDA approval was based on the results of a phase 3 clinical trial in which KIMMTRAK showed statistically and clinically meaningful overall survival benefit for mUM patients. A total of 378 previously untreated patients were randomly assigned to either the KIMMTRAK (tebentafusp) group (252 patients) or the control group (126 patients). The control group received single-agent treatment with pembrolizumab (82% of control patients), ipilimumab (13%), or dacarbazine (6%). Overall survival (OS) at one year was 73% in the tebentafusp group and 59% in the control group.

Uveal melanoma is the most common intraocular cancer in adults, and about 50% of people with uveal melanoma will develop metastases. The prognosis for mUM patients is very poor, with the median overall survival after diagnosis being just one year. Before today, there were no approved systemic treatment options for mUM patients.

“KIMMTRAK offers hope for patients and families suffering from a devastating disease,” said Marlana Orloff, M.D., one of the study investigators. “Now, with KIMMTRAK’s approval, it’s the first time we can tell our mUM patients and families that there is a systemic treatment available that has been shown to extend survival.”

KIMMTRAK is also the first T cell receptor therapeutic to receive regulatory approval.


ABOUT THE AIM AT MELANOMA FOUNDATION:  Melanoma is one of the fastest growing cancers in the United States and worldwide.  It’s one of the most complex forms of cancer and has the most mutations of all solid cancers.  Founded in 2004, AIM at Melanoma is a global foundation dedicated to finding more effective treatments and, ultimately, the cure for melanoma while improving the lives of those it affects.  AIM’s global research initiatives include The International Melanoma Tissue Bank Consortium, The Melanoma International Collaboration for Adaptive Trials, and the International Melanoma Working Group.  AIM at Melanoma provides education, connection to resources and opportunities for meaningful engagement to help patients and caregivers/families better face the challenges of melanoma.