The tebentafusp has earned a breakthrough designation for ocular cancer. The company is planning regulatory filings in the U.S. later this year and in Europe thereafter.
Recently, tebentafusp earned a breakthrough designation.
Hot on the heels of its $297 million IPO earlier this month, British T cell receptor company Immunocore announced a U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for its lead asset tebentafusp, currently in Phase III testing for a rare ocular melanoma. The company is planning regulatory filings in the U.S. later this year and in Europe thereafter.
Last year, Immunocore announced positive interim data for its Phase III trial in metastatic uveal melanoma (mUM) for tebentafusp, which is a soluble gp100-targeting T-cell receptor fused to an anti-CD3 single-chain variable fragment. The bispecific improved overall survival compared with the investigator’s choice of therapy, in most cases Merck & Co’s Keytruda. Keytruda is approved for cutaneous forms of metastatic melanoma and is regularly used to treat mUM, but no drug has been approved specifically for the rare subtype, and it has only shown efficacy for a limited number of responders in small clinical trials.
The new FDA designation means tebentafusp will remain in FDA’s Fast Track program and represents a commitment to rolling and priority drug reviews for HLA-A*02:01-positive adults with unresectable uveal melanoma or mUM. Immunocore intends to file a Biologics License Application in Q3, upon completion of its Phase III study, followed by a Marketing Authorization Application submission to the European Medicines Agency. The drug also has the Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme.
“There is an urgent need for an approved treatment for this rare and aggressive form of melanoma,” said Bahija Jallal, Immunocore’s CEO. “We look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible.” The company estimates no drug has been approved for mUM in 40 years.
Although rare–diagnosed in about 2,500 patients in the U.S. each year–uveal melanoma is malignant in about half of all patients, making it the most common ocular malignancy in adults. At least four other companies have therapies in clinical development for mUM. Tebentafusp’s leading competitor is AU-011, a virus-like drug conjugate by Aura Biosciences that begun dosing patients in a Phase II trial last year. Replimmune has RP2-001 in Phase I/II testing as a monotherapy in immune insensitive tumor types, including uveal melanoma patients. And two companies–Provectus Biopharmaceuticals and Ideaya Biosciences–have therapies in Phase I testing in combination with checkpoint inhibitors.
Immunocore also has three other T-cell receptor bispecifics in clinical testing for a range of tumors, and similar virus-targeting platform, with a candidate in Phase I testing in Hepatitis B.
