NEW YORK – Immunocore said on Monday that the European Commission approved its T-cell receptor therapy Kimmtrak (tebentafusp) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
The approval comes two months after the US Food and Drug Administration approved Kimmtrak for the same indication. The EC has taken the advice of the European Medicines Agency's Committee for Medicinal Products for Human Use to make Kimmtrak available in this setting.
T-cell receptor (TCR) bispecific immunotherapies are a new class of drugs that redirect T cells to tumors by linking an antigen recognition domain with a T-cell engaging domain. The strategy is designed to overcome cancer cell mechanisms that suppress T-cell immune responses. Immunocore has engineered its ImmTAC molecules to recognize cancer cells by targeting glycoprotein 100 (gp100), which is highly expressed in melanoma tissue, and kill them using an anti-CD3 immune-activating effector function.
Kimmtrak is the first TCR therapy approved in the US and the European Union. A Phase III trial showed increased overall survival for HLA-A*02:01-positive advanced uveal melanoma patients on Kimmtrak compared to Merck's Keytruda (pembrolizumab), Bristol Myers Squibb's Yervoy (ipilimumab), or dacarbazine chemotherapy. Even among patients who experienced disease progression, the trial showed a benefit in terms of median overall survival benefit, 15.3 months in the Kimmtrak arm compared to 6.5 months for the control group. The study authors noted that several patients receiving Kimmtrak had regression of some target lesions, in spite of overall disease progression. Others had no tumor shrinkage or tumor growth yet still experienced an overall survival benefit.
Adverse events associated with Kimmtrak include rash, fever, and itching. A more serious adverse event, cytokine release syndrome, occurred in less than 1 percent of patients in studies.