NEW YORK – Immunocore said Wednesday that Kimmtrak (tebentafusp) received marketing authorization from regulatory authorities in the United Kingdom, Australia, and Canada for treatment of HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma.
The approvals from the UK's Medicines and Healthcare Products Regulatory Agency, Australia's Therapeutic Goods Administration, and Health Canada are based on results of a Phase III trial in which Kimmtrak was pitted against investigator's choice of treatment with Merck's Keytruda (pembrolizumab), Bristol Myers Squibb's Yervoy (ipilimumab), or dacarbazine chemotherapy. At one year, 73 percent of patients were alive on Kimmtrak, while 59 percent were alive in the control arm. Treatment-related adverse events were manageable, and less than 1 percent of patients on Kimmtrak experienced cytokine release syndrome.
Immunocore used its ImmTAC platform to develop Kimmtrak, a T-cell receptor bispecific immunotherapy. The drug targets glycoprotein 100 (gp100) on cancer cells and kills them through an anti-CD3 immune-activating effector function.
The US Food and Drug Administration and the European Commission also recently approved Kimmtrak for HLA-A*02:01-positive advanced uveal melanoma. Patients with this cancer typically have a poor prognosis, and Kimmtrak is the first approved treatment in this setting in the UK, Australia, and Canada.
The FDA's Project Orbis initiative enabled health authorities in Australia, Canada, and the UK to simultaneously review the data on Kimmtrak and prioritize its path to market. Immunocore is partnered with Medison Pharma for marketing of the drug in Australia and Canada, as well as in 20 other markets in Europe, Israel, and New Zealand.