European Commission approves treatment of unresectable uveal melanoma

Immunocore Holdings has announced that the European Commission has approved KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatcv uveal melanoma (mUM).

Kimmtrack is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function.

“The approval of KIMMTRAK by the European Commission is a historic step as the first ever TCR therapy to be approved in the EU,” said Bahija Jallal, Chief Executive Officer of Immunocore. “KIMMTRAK, a bispecific T-cell engager, is the first therapy to demonstrate a survival benefit in patients with unresectable or metastatic uveal melanoma. We are excited about what today’s approval means for patients and their caregivers and we are working closely with national health authorities to make KIMMTRAK available as quickly as possible.”

Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies, designed to treat a broad range of diseases. These diseases include cancer, autoimmune, and infectious diseases.

Dr Jessica Hassel, Head of Dermatooncology at Heidelberg University Hospital, commented: “The approval of tebentafusp by the EMA is a great step forward in the treatment of metastatic uveal melanoma. Being the first agent with a proven survival benefit, this approval provides hope to patients with uveal melanoma. And for us treating physicians, it is a significant advancement to be able to offer these patients an effective treatment with good tolerability.”

With the EC approval, Kimmtrak has received marketing authorisation in all EU member states, and following completion of related national procedures, also in Iceland, Liechtenstein, and Norway.

“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,” shared Dr Sophie Piperno-Neumann, Medical Oncologist at the Institute Curie. “As a treating physician, it is heart-warming to finally be able to offer a licensed medicine to eligible patients. KIMMTRAK represents a paradigm shift in the treatment of unresectable or metastatic uveal melanoma.”

Ana Ovey