Immunocore wins FDA nod for first uveal melanoma treatment, also first T-cell receptor therapeutic

Uveal melanoma, an aggressive cancer of the eye, has been a particularly tough nut to crack for scientists trying to find a treatment.

But with a new treatment approved on Wednesday by the FDA, those with the disorder will have a greater chance to survive. The U.S. regulator signed off on Immunocore’s Kimmtrak (tebentafusp-tabn), the first therapy for unresectable or metastatic uveal melanoma (mUM) and the first drug of its class, as a T-cell receptor therapeutic, to be approved.

“We are truly pioneering a new class of therapeutics. There’s not a lot of times you can say that in your career, so I’m going to say it again,” Bahija Jallal, CEO of Immunocore, said in an investor call.

The FDA blessing for the infused treatment came a month ahead of the target date and five months after regulators in the U.S. and Europe accepted Immunocore’s biologic license application. The company expects a nod soon from the European Medicines Agency and plans a launch there in the second quarter of this year, starting in Germany, Immunocore's chief financial officer, Brian Di Donato, said

The launch will begin “immediately,” in the U.S., according to Jallal, and available to patients within a few weeks.

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Kimmtrak will be priced at $18,760 per vial, which contains a weekly dose. With the median treatment duration lasting 5.3 months, the average cost per patient will equate to approximately $400,000.

Immunocore has established a Kimmtrak Connect program, which will help patients access the treatment regardless of their financial situation, Ralph Torbay, the company’s commercial chief, said.

A significant market awaits as each year in the U.S. roughly 1,700 people are diagnosed with uveal melanoma, Immunocore’s chief clinical officer, Mohammed Dar said. Patients lose vision in the affected eye and then have to wait a certain period of time to see if the melanoma will return. In about 50% of cases, it does return and usually metastasizes to the liver, Dar added.

"We think the approval is a nice validation of the Immunocore soluble bispecific T-cell receptor platform and look forward to additional and important phase 1/2 solid tumor Prame and Mage-A4 data later this year," analysts at Jefferies wrote in a note to investors.

The FDA endorsement was based on a phase 3 trial of 378 newly diagnosed patients. The study measured Kimmtrak, a bispecific T-cell engager, against three established treatments used for the disease—two immune checkpoint inhibitors and a chemotherapy drug, depending on the choice of the investigator. Of those in the control group, 82% were provided with Merck’s Keytruda.

The median overall survival rate of Kimmtrak was 21.7 months versus 16 months for patients in the control group, with an almost 50% lower risk of death.

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There are potential side effects with Kimmtrak, such as rash, chills, fever, nausea, hypotension, hypoxia and headache. The most severe side effect is cytokine release syndrome, which requires patients to be monitored for 16 hours after administration of the first three doses. In the U.S., this can usually be achieved in an outpatient setting, said Dar.

“We’ve now dosed over 700 patients with Kimmtrak and have found that the safety profile is quite predictable and manageable,” Dar said. “This is really a new class of therapy so we’re going to continue to learn over time, based on the emerging data, what is the best way to monitor.”