The recent Food and Drug Administration (FDA) approval of the first T-cell receptor (TCR) therapy, Immunocore’s ($IMCR) Kimmtrak, for the treatment of uveal melanoma offers such a clear benefit to patients that it will become the standard of care in the US, says GlobalData. The leading data and analytics company estimates the annual cost of treatment with Kimmtrak to be extremely high, between $400,000 and $500,000 in the US.

Uveal melanoma is a rare cancer of the eye, which in the majority of patients is localized. However, upon becoming metastatic (mUM), the prognosis is dismal, with patients surviving only a year on average.

Sakis Paliouras, PhD, Managing Oncology Analyst at GlobalData, comments: “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.”

Currently mUM is being treated with off-label drugs, including immune checkpoint inhibitors (ICIs) and the chemotherapeutic dacarbazine. The late-stage pipeline of mUM also includes ICIs and tyrosine kinase inhibitors, which cannot threaten Kimmtrak in the future unless compared head-to-head with it, with no such trials in the pipeline.

Paliouras continues: “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.”

Despite the rarity of mUM, this is a big commercial opportunity for Immunocore ($IMCR), as Kimmtrak’s high expected clinical uptake could easily result in global peak sales of over $100 million.

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