Tebentafusp

Kimmtrak®

A bispecific protein consisting of a soluble T-cell receptor (TCR) fused to an anti-CD3 immune effector function. The TCR domain binds to a gp100 peptide presented on the cell surface of uveal melanoma cells by HLA-A*02:01.

May 2023

Tebentafusp is indicated as monotherapy for the treatment of HLA (human leukocyte antigen) A*02:01-positive adult patients with inoperable or metastatic uveal melanoma.

Differential blood count, blood chemistry panel (Na, K, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, AST, ALT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose, cortisol, TSH, fT4, high-sensitivity troponin T, troponin I, NT-proBNP, S-100, pregnancy test, viral serology tests as needed (hepatitis B/C, HIV, CMV, EBV).

ECG, echocardiography (if cardiovascular risk is present).

20 micrograms on day 1, 30 micrograms on day 8, 68 micrograms on day 15, and 68 micrograms once a week thereafter.

As a general rule, the first three infusions should be administered on an inpatient basis.

Before each dose: Differential blood count, blood chemistry panel (Na, K, chloride, calcium, phosphate, urea, creatinine, uric acid, bilirubin, AST, ALT, gamma-GT, alkaline phosphatase, LDH, pancreatic amylase, total protein, CRP, CK), glucose; every 2 months: TSH, fT4.

Treatment should be continued as long as it provides clinical benefit to the patient and no unacceptable toxicity occurs.

Primary prophylaxis: To minimize the risk of hypotension associated with cytokine release syndrome, intravenous fluid administration may be considered.

See medical literature, guidelines, and study results.