The new therapy treats patients with unresectable or metastatic uveal melanoma.
The FDA approved Immunocore’s Kimmtrak (tebentafusp-tebn) for unresectable or metastatic uveal melanoma (mUM), which the company says is the agency’s first approval of a T cell receptor (TCR) treatment.
The novel class of TRC bispecific immunotherapies are designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases. Kimmtrak treats HLA-A*02:01-positive adult patients with unresectable or mUM.
Kimmtrak is also the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA, Immunocore said in a news release.
“Every year in the United States, hundreds of people are diagnosed with metastatic uveal melanoma who, until now, had no approved treatment options,” said Bahija Jallal, CEO of Immunocore. “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.”
The company expects Kimmtrak to be commercially available in the US within weeks.
The world’s first approved TCR therapeutic also “opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need,” Jallal said.
“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood, M.D., director of the Melanoma Center at the UPMC Hillman Cancer Center in Pittsburgh, in the news release. “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.”
The approval of Kimmtrak is based on the results of Immunocore’s phase 3 IMCgp100-202 clinical trial, the results of which were published in the September 23, 2021, issue of the New England Journal of Medicine.
The randomized pivotal trial evaluated overall survival (OS) of Kimmtrak compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM.
Results from the trial — the largest phase 3 trial undertaken in mUM — showed positive results from that Kimmtrak. The overall survival hazard ratio in the intention-to-treat analysis favored the new drug over other drugs (82%, Keytruda (pembrolizumab); 13%, Yervoy (ipilimumab) ; and 6%, dacarbazine).
The European Medicines Agency, the United Kingdom’s Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have accepted the submission of the company’s application.
In addition, Immunocore launched a global early access program to make Kimmtrak available to mUM patients. There are more than 200 patients in 13 countries in the early access program.