Immunocore’s Kimmtrak Gets FDA Approval as First Treatment for Rare Eye Cancer and First T Cell Receptor Therapeutic

Immunocore, a commercial-stage biotechnology company developing T cell receptor (TCR)-based immunotherapies in oncology, autoimmune and infectious diseases, has won approval from the US Food and Drug Administration (FDA) for its novel immunotherapy Kimmtrak (tebentafusp-tabn), making it the first approved treatment for unresectable or metastatic uveal melanoma and first TCR therapeutic to receive regulatory approval.

Kimmtrak is part of a novel class of bispecific T cell immunotherapies being developed by Immunocore. Kimmtrak has also become the first bispecific T cell engager to be FDA-approved for the treatment of a solid tumor.

Uveal melanoma is a rare and aggressive type of melanoma of the eye. Up to 50 percent of patients will develop metastatic disease, mainly spreading to the liver, making treatment difficult and limited. As such, unresectable or metastatic uveal melanoma usually has a poor prognosis and until the approval of Kimmtrak, there was no approved treatment. The new treatment will thus help address the unmet need for the disease.

Immunocore was granted the approval for Kimmtrak several weeks ahead of the scheduled PDUFA date of February 23. Immunocore received Breakthrough Therapy Designation for Kimmtrak from the FDA in February 2021 followed by acceptance of its Biologics License Application (BLA) several months later by both US and European regulators. The company is expecting approval from the European Medicines Agency (EMA) soon as it prepares for a European launch in the second quarter of this year.

Kimmtrak has a price tag of $18,760 per vial, which amounts to a weekly dose. The median treatment time is about 23 weeks (or 5.3 months), so the average cost per patient will be approximately $400,000.

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Kimmtrak is a bispecific protein that contains a soluble T cell receptor fused to an anti-CD3 immune-effector function. It targets gp100, which is a glycoprotein expressed in melanocytes and a tumor-associated antigen in melanoma.

“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,” Bahija Jallal, chief executive officer of Immunocore, said in a news release from the company.

“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.”

Kimmtrak was the first molecule Immunocore developed using its proprietary ImmTAC technology platform.

The FDA approval was based on the Phase III IMCgp100-202 randomized controlled trial that included 378 newly diagnosed, previously untreated patients with metastatic uveal melanoma. The study evaluated the effectiveness of Kimmtrak against two immune checkpoint inhibitors (Merck’s Keytruda and Bristol Myers Squibb’s Yerboy) and the chemotherapy dacarbazine (as per clinician choice) used as conventional treatments for the disease. In the control group, 82 percent of patients were given Merck’s Keytruda.

Kimmtrak led to a nearly 50 percent lower risk of death and a median overall survival rate of 21.7 months versus 16 months for patients in the control group.

Immunocore’s commercial chief Ralph Torbay said the company has created a Kimmtrak Connect program to help patients access the therapy irrespective of their financial situation.

“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,” said Jallal.