The functions and efficacy of Tebentafusp-tebn
Tebentafusp-tebn is a first-in-class investigational bispecific fusion protein consisting of a soluble affinity-enhanced HLA-a* 02:01-restricted T-cell receptor specific for the gp100 peptide (YLEPGPVTA) fused to an anti-CD3 scFv. These ImmTAC (Immune Mobilizing Monoclonal T Cell Receptor Against Cancer) molecules redirect and activate polyclonal T cells toward target cells that present peptide-HLA complexes on their cell surfaces.
The first-in-human (FIH) multicenter Phase I study of tebenforxide enrolled patients with HLA-A*02-positive advanced melanoma, including 19 patients with uveal melanoma (UM) , 61 patients with metastatic cutaneous melanoma (CM) and 4 patients with other melanoma subtypes, with an established maximum tolerated dose (MTD) of 50 μg when administered at a fixed once-weekly dose. No differences in efficacy were observed when administered using this weekly fixed-dose regimen or when administered using a daily dosing regimen. Of the 15 evaluable patients with mUM, 20% achieved partial response (PR) and 47% achieved stable disease. Greater responses were observed at dose levels at or above the maximum tolerated dose, suggesting a dose-response relationship. Although dose is limited by toxicities, including cytokine release syndrome (CRS), these toxicities are manageable and reversible within 24 hours and are mostly limited to the first 2 weeks of treatment.
The original drug of Tibenforsi is not currently on the market in China, nor has it been included in medical insurance. After Tebenforx is approved for marketing, there may be less price and other related information. For more drug information and specific prices, please consult a medical consultant.
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