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First Treatment for Unresectable or Metastatic Uveal Melanoma Approved in Europe

Anna Osborne
6 April 2022
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Immunocore, a commercial-stage biotechnology company, has announced European Commission approval of KIMMTRAK, a TCR therapy for the treatment of unresectable or metastatic uveal melanoma in HLA-A*02:01-positive adult patients.

“The approval of KIMMTRAK by the European Commission is a historic step as the first ever TCR therapy to be approved in the E.U.,” notes Bahija Jallal, CEO of Immunocore.

A bispecific protein comprising of a soluble T cell receptor and anti-CD3 immune-effector function, KIMMTRAK is built using Immunocroe’s off-the-shelf ImmTAC technology platform.

This EC approval provides KIMMTRAK with marketing authorization in all E.U. countries, as well as, after following national procedures, Iceland, Liechtenstein, and Norway. KIMMTRAK has also been permitted for treatment in the U.S. following FDA approval in January 2022.

Additionally, the submission of Immunocore’s Marketing Authorization Application has been accepted by the United Kingdom’s Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration.

Ahead of this EC approval, the Committee for Medicinal Products for Human Use presented a positive opinion and recommendation of KIMMTRAK in February 2022, based on the results from Immunocore’s Phase III IMCgp-100-202 trial of KIMMTRAK for unresectable or metastatic uveal melanoma in HLA-A*02:01-positive adult patients.

IMCgp-100-202 was the largest Phase III trial to take place in unresectable or metastatic uveal melanoma. It reported that KIMMTRAK demonstrated overall survival benefits to patients as a first-line treatment. Of the 245 patients treated with KIMMTRAK in the randomized trial, Grade 3 cytokine release syndrome occurred in less than 1% of patients, with other treatment-related adverse reactions manageable. There were no adverse reactions above Grade 3.

Uveal melanoma is a rare and aggressive form of cancer, with 50% of patients progressing to metastatic disease, which currently has a poor prognosis.

“For years, metastatic uveal melanoma patients have had no treatment choice that is active – today’s approval offers them new hope and a chance at longer survival,” comments Dr. Sophie Piperno-Neumann, Medical Oncologist at the Institute Curie.

Source: Immunocore Press Release