FDA approves Kimmtrak for unresectable or metastatic uveal melanoma
The FDA approved tebentafusp-tebn for the treatment of adults with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
Tebentafusp-tebn (Kimmtrak, Immunocore) — the only FDA-approved treatment for this indication — is the first T-cell receptor therapeutic to receive regulatory approval.
Tebentafusp-tebn is a bispecific protein composed of a soluble T-cell receptor fused to an anti-CD3 immune-effector function. The agent targets gp100, a lineage antigen expressed in melanocytes and melanoma.
“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” John Kirkwood, MD, director of the Melanoma Center at the UPMC Hillman Cancer Center, said in an Immunocore-issued press 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 randomized phase 3 IMCgp100-202 trial included 378 patients with previously untreated metastatic uveal melanoma. Researchers randomly assigned them 2:1 to tebentafusp-tebn or investigator’s choice of therapy, which included pembrolizumab (Keytruda, Merck), ipilimumab (Yervoy, Bristol Myers Squibb) or dacarbazine.
As Healio previously reported, the trial achieved its primary endpoint of OS.
Results presented at last year’s virtual American Association for Cancer Research Annual Meeting and later published in The New England Journal of Medicine showed tebentafusp-tebn monotherapy conferred a statistically significant improvement in OS compared with investigator’s choice of therapy (median, 21.7 months vs. 16 months; HR = 0.51; 95% CI, 0.36-0.71).
Researchers reported estimated 1-year OS rates of 73.2% in the tebentafusp-tebn group vs. 58.5% in the investigator’s choice group, and they observed benefit across patient subgroups.
The most common grade 3 or higher treatment-related adverse events in the tebentafusp-tebn group included rash (18%), pyrexia (4%) and pruritus (5%). Less than 1% of patients developed grade 3 cytokine release syndrome, and no grade 4 or fatal CRS events occurred in the trial.
“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, CEO of Immunocore, said in the release. “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 FDA previously granted priority review designation to tebentafusp-tebn for this indication.