Kimmtrak tebentafusp

Drug Class

Bispecific gp100 peptide-HLA-directed TCR-CD3 T-cell engager

Mechanism

Redirects CD3-positive T cells to target and kill uveal melanoma cells expressing the gp100 tumor-associated antigen.

Approved Indication

HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma, per its FDA approval.

What This Means For Patients

Kimmtrak is a bispecific protein therapy specifically indicated for HLA-A*02:01-positive patients with advanced uveal melanoma (a rare form of eye cancer). It acts by linking cancer cells with active immune cells to trigger tumor destruction, available in Hainan Lecheng.

Regulatory Approvals

• FDA — approved (2022) — label

Pivotal Clinical Evidence

• IMCgp100-202 — Nathan et al., N Engl J Med 2021 (NCT03070392) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf