EU approves Kimmtrak for unresectable or metastatic uveal melanoma
Immunocore announced that the European Commission (EC) has approved Kimmtrak (tebentafusp) for the treatment of HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
Kimmtrak is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.
The CHMP recommendation of Kimmtrak is based on the results of Immunocore’s Phase III IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. Data from the trial, the largest Phase III trial undertaken in mUM, showed that Kimmtrak demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favoured Kimmtrak, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice of treatment (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In this study IMCgp100-202, 43% of patients received treatment beyond progression with tebentafusp with no new safety signals identified. Median duration of tebentafusp treatment beyond progression was 8 weeks. Of the total tebentafusp infusions during the study, 21.5% was administered after progression. In the trial, treatment-related adverse reactions were generally manageable and consistent with the proposed mechanism of action.
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