Kimmtrak / tebentafusp

Kimmtrak (tebentafusp) is indicated as a monotherapy for the treatment of human leukocyte antigen (HLA) A*02:01 positive adult patients with unresectable or metastatic uveal melanoma (mUM). The marketing authorisation application was submitted on 23 July 2021, and a positive opinion for marketing authorisation was granted on 24 February 2022, following an accelerated assessment.

In a Phase III trial involving 252 patients, tebentafusp was compared against investigator's choice of ipilimumab, dacarbazine, or pembrolizumab. For single-agent chemotherapy in mUM, the median overall survival was 10 months, and for single-agent immune checkpoint inhibitors, it was 6-10 months. The median overall survival for ipilimumab monotherapy in mUM was 6.8 months, with a 1-year overall survival rate of 22%. In a meta-analysis, the median overall survival in mUM was 9 months, with a 1-year overall survival rate of 43%. The median overall survival in 1L mUM was 12 months, with a 1-year overall survival rate of 52%.

Regarding safety, 100% of patients experienced any treatment-emergent adverse event (TEAE). TEAEs leading to discontinuation of the study drug occurred in 5.5% to 23.1% of patients. Grade ≥3 AEs were reported in 44.5% to 47.6% of patients, and serious adverse events (SAEs) occurred in 23.4% to 31.2% of patients. Treatment-related deaths were reported in 3.8% of cases.