CHMP recommends approval of Kimmtrak for uveal melanoma.- Immunocore

The active substance, tebentafusp, an antineoplastic agent with bispecific affinity, targeting the CD3 T cells and a gp100 peptide on the surface of uveal melanoma tumour cells. This redirects and activates T cells and results in direct lysis of uveal melanoma tumour cells.

The benefits of Kimmtrak are a gain in median overall survival of 5.7 months over the investigator’s choice treatment as observed in a randomised, open label, multicentre pivotal study. The most common side effects are cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, oedema, hypo/hyperpigmentation, hypotension, dry skin, headache and vomiting. The full indication is: Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA) A 02:01 positive adult patients with unresectable or metastatic uveal melanoma.