|Other names||IMCgp100, tebentafusp-tebn|
|Drug class||Bispecific gp100 peptide-HLA-directed CD3 T cell engager|
|Main uses||Uveal melanoma|
|Side effects||Cytokine release syndrome, rash, fever, itching, tiredness, nausea, abdominal pain, swelling, low blood pressure, dry skin, headache, vomiting|
|Typical dose||20 to 68 mcg|
Tebentafusp, sold under the brand name Kimmtrak, is an medication used to treat a type of eye cancer, known as uveal melanoma. It is used in HLA-A*02:01-positive cases that cannot be managed by surgery alone. It is given by injection into a vein. Due to the risk of side effects nearly a day of monitoring is required after the initial doses.
Common side effects include cytokine release syndrome, rash, fever, itching, tiredness, nausea, abdominal pain, swelling, low blood pressure, dry skin, headache, and vomiting. Use in pregnancy may harm the baby. It is a bispecific gp100 peptide-HLA-directed CD3 T cell engager.
Tebentafusp was approved for medical use in the United States and Europe in 2022. In the United States the medication costs about 18,800 USD per dose. While available in the United Kingdom, the cost is yet to be determined.
It improves typical survival over standard treatment from 16 months to to 22 months.
The initial dose is typically 20 mcg, followed by 30 mcg on day 8 and 68 mcg on day 15 followed by 68 mcg weekly after that.
Efficacy was evaluated in IMCgp100-202 (NCT03070392), a randomized, open-label, multicenter trial of 378 participants with metastatic uveal melanoma. Participants were required to be HLA-A*02:01 genotype positive identified by a central assay. Participants were excluded if prior systemic therapy or localized liver-directed therapy were administered. Prior surgical resection of oligometastatic disease was permitted. Participants with clinically significant cardiac disease or symptomatic, untreated brain metastases were excluded.
Society and culture
On 24 February 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Kimmtrak, intended for the treatment of uveal melanoma. The applicant for this medicinal product is Immunocore Ireland Limited. Tebentafusp was approved for medical use in the European Union in April 2022.
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