Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

Immunocore receives positive CHMP opinion for KIMMTRAK® (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma

If approved by the European Medicines Agency, KIMMTRAK will be the first and only treatment option approved in Europe to treat patients with unresectable or metastatic uveal melanoma

KIMMTRAK demonstrated statistically and clinically meaningful overall survival (OS) benefit, hazard ratio of 0.51, with median OS of almost 22 months

Excerpt from the Press Release:

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 25 February 2022) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), 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, including cancer, autoimmune and infectious diseases today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of KIMMTRAK® (tebentafusp) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

The CHMP positive opinion is one of the final steps before marketing authorization is granted by the EMA, which has the authority to approve medicines for use throughout the European Union. If approved, KIMMTRAK® would be the first T cell receptor therapy commercially available in Europe. Immunocore’s Marketing Authorisation Application was reviewed under EMA’s accelerated assessment procedure, which is given if the CHMP determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.

“The CHMP’s recommendation of KIMMTRAK brings us closer to providing a much-needed treatment option to patients in Europe,” said Bahija Jallal, Chief Executive Officer of Immunocore. “This year, hundreds of people across the EU will be diagnosed with metastatic uveal melanoma. Left with minimal-to-no options, these patients have a devastating prognosis. KIMMTRAK is the first therapy to demonstrate a survival benefit in patients with this disease, providing new hope to these individuals and to the doctors treating them.”

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