Immunocore now has approval on both side of the Atlantic for Kimmtrak – the first cancer therapeutic based on T cell receptor (TCR) technology – after getting a green light from the European Commission.
Kimmtrak (tebentafusp) has been cleared to for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), mirroring its label in the US.
The therapy is a bispecific T cell engager (BiTE) molecule, consisting of a soluble TCR targeting gp100 expressed on cancer cells fused to a protein that binds CD3 receptors on lymphocytes. It’s the first treatment for mUM in the EU, as well as the first BiTE drug to treat a solid tumour.
Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localised. However, when it becomes the prospects for patients are very poor, with a survival duration of only a year on average.
Oxford, UK-based Immunocore said the approval is based on the phase 3 IMCgp100-202 trial, which showed that Kimmtrak achieved an unprecedented improvement in overall survival when added to current first-line therapy for mUM.
The one-year survival rate with the drug was 73%, compared to 58% in a group receiving standard-of-care – 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.
mUM is the most common form of cancer affecting the eye in adults, but is still rare, diagnosed in a around 1,700 patients each year in the US, with a few hundred already with metastatic disease that has spread to other tissues.
The European population is meanwhile estimated at several thousand patients, across all stages, according to registry data.
Kimmtrak has launched in the US with an annual price tag of around $400,000 a year, reflecting the small target population, and analysts at GlobalData think that could help drive sales above $100 million – a sizeable figure for a small company like Immunocore with no other approved drugs.
GlobalData analyst Dr Sakis Palioras said in a recent research not that Kimmtrak’s 5.7 month improvement in overall survival versus off-label therapy shows “clear superiority [with] little doubt regarding the best frontline treatment and leaves only its very high cost as a potential concern for prescribing physicians.”
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