Immunocore's rare eye cancer drug backed by NICE

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Man having an eye test
Paul Diaconu

Hundreds of people in England with a rare form of cancer affecting the eye will soon be able to access a pioneering therapy based on T-cell receptor (TCR) technology, developed by Immunocore.

Cost-effectiveness agency NICE has recommended NHS use of the therapy, called Kimmtrak (tebentafusp), for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM) – changing its position after issuing a negative opinion last year, which went to appeal.

It is the first treatment of its kind for mUM, a cancer that develops from cells in the middle layer of the eye, known as the uvea. It is very uncommon – affecting a few thousand people across Europe as a whole – and has a poor prognosis when diagnosed at an advanced stage, with patients typically living for only a year on average.

Kimmtrak takes the form of a bispecific T-cell engager (BiTE) molecule, made up of a soluble TCR targeting gp100 expressed on cancer cells fused to a protein that binds CD3 receptors on lymphocytes, stimulating an immune response against the tumour.

In the phase 3 IMCgp100-202 trial, Kimmtrak achieved an unprecedented improvement in overall survival when added to current first-line therapy for mUM – off-label immune checkpoint inhibitors used for other forms of melanoma like Merck & Co's Keytruda (pembrolizumab) and Bristol-Myers Squibb's Yervoy (ipilimumab) or chemotherapy with dacarbazine.

The one-year survival rate with the drug was 73%, compared to 58% in a group receiving standard-of-care alone.

"Access to the first therapy that improves survival for this rare and threatening disease marks a major step forward," commented Professor Paul Nathan, consultant medical oncologist at Mount Vernon Cancer Centre in Middlesex, UK.

He added, however, that there "remains much work to be done to build upon this advance," so that they can "further improve outcomes for all patients."

mUM is thought to affect 500 to 600 people in the UK and around half of patients will be diagnosed with advanced disease. Patients will need a test to see if they will be eligible for treatment with Kimmtrak, which Immunocore has agreed to provide at a confidential discount to its UK list price of £10,114 per 200mcg/1ml vial.

NICE's change of heart on Kimmtrak has been welcomed by patient organisation Ocular Melanoma UK. Chief executive and founder Jo Gumbs said that it is a groundbreaking moment for patients, as the decision "highlights the power of collaboration between patients, advocates, and medical experts."

Kimmtrak is Immunocore's first commercial product and has grown quickly since launch, with sales reaching $226 million in the first nine months of this year. The company is also carrying out a pair of phase 3 trials in cutaneous melanoma – PRISM-MEL-301 and TEBE-AM – and is due to start a third in adjuvant uveal melanoma (ATOM) before year-end.

Image by Paul Diaconu from Pixabay