America’s FDA approves eye tumour treatment from Oxfordshire-based biotech company Immunocore

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Oxfordshire-based biotech company Immunocore has received regulatory clearance from the US Food and Drug Administration for Kimmtrak, a brand new eye tumour treatment.

Uveal melanoma is a cancer of the eye. Tumours arise from the pigment cells that give colour to the eye. Although relatively rare – between 700 and 800 people are diagnosed with uveal melanoma in the UK each year – the survival rate for people unlucky enough to develop it is just 15 per cent, and death within a year is common.

Immunocore, based at Milton Park, Abingdon is a clinical-stage biotech company born out of the research labs at Oxford University in 2008. It is developing biological drugs, so-called Immune mobilising monoclonal T cell receptor (TCR) against cancer (ImmTAC) molecules, to treat cancer, autoimmune diseases and infectious diseases using soluble T-cell receptor (TCR) technology.

The FDA’s approval establishes a number of firsts. Kimmtrak is the first TCR therapeutic to receive regulatory approval from the FDA, the first bi-specific T cell engager to receive regulatory approval from the FDA to treat a solid tumour, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma – those not able to be surgically removed – to be approved by the FDA.

Bahija Jallal, Immunocore’s CEO, said: “Today’s approval of Kimmtrak is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners.

“Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options.

“Kimmtrak is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making Kimmtrak available as quickly as possible.

“We’re also proud to have developed the world’s first approved TCR therapeutic, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need.”

John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center in Pennsylvania, said: “Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients.

The approval of Kimmtrak represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.”

London-based data analytics firm GlobalData said that despite its high price tag – between $400,000 and $500,000 per patient – Kimmtrak was likely to dominate the uveal melanoma market.

Sakis Paliouras, PhD, managing oncology analyst at GlobalData, said: “Uveal melanoma is a true orphan indication for which novel therapies are urgently needed.

“Kimmtrak increased the overall survival of patients by 5.7 months compared to investigator’s choice in the largest mUM trial to date, with manageable side effects.

“This clear superiority leaves little doubt regarding the best frontline treatment and leaves only its very high cost as a potential concern for prescribing physicians.”

He added: “While its price tag will be a concern in more cost-conscious markets, such as the UK, in the US there is a precedent of innovative oncology drugs being adopted as the standard of care irrespective of price.

“Crucial to Kimmtrak’s commercial success will be a marketing authorisation in Europe. With an authorisation application submitted under accelerated assessment in August 2021, Kimmtrak could see an entry in European markets as early as Q3 2022.”

Kimmtrak’s high expected clinical uptake could easily result in global peak sales of over $100 million, said GlobalData.

Pictured: the FDA’s Center for Drug Evaluation and Research. Image courtesy of The U.S. Food and Drug Administration, published under Creative Commons license