Metastatic uveal melanoma responds poorly to checkpoint inhibitors, and no therapy had ever demonstrated a survival benefit. Kimmtrak (tebentafusp) was the first to do so.
It uses an engineered T-cell receptor recognizing gp100 on melanoma cells, fused to an anti-CD3 domain that physically recruits T cells to kill them. The weekly intravenous infusion treats HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.
Kimmtrak requires HLA genotyping, which restricts eligibility to roughly half of patients, and initial dosing must occur in hospital because of cytokine release risk. As the first approved ImmTAC, it is the platform-validating asset for the broader TCR bispecific field.