FDA approves Kimmtrak for metastatic uveal melanoma.

This marks the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

The approval 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. The randomized pivotal trial evaluated overall survival (OS) of Kimmtrak compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized in a 2:1 ratio to either Kimmtrak or investigator’s choice.

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 favored Kimmtrak, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the clinical trials, across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity.