EU Approves Immunocore’s Kimmtrak for Patients With Unresectable/Metastatic Uveal Melanoma

The European Commission has approved Immunocore’s T-cell receptor (TCR) bispecific immunotherapy drug Kimmtrak (tebentafusp) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma — the first regulatory approval for a TCR treatment in the EU.

The European Medicines Agency’s recommendation for approval was supported by positive phase 3 study results. In the clinical trial, which enrolled 378 participants, the primary endpoint of overall survival was met, with patients in the Kimmtrak group achieving 73 percent overall survival at one year compared with 59 percent in the investigator’s choice of therapy group.

The FDA approved Kimmtrak for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in January.