The FDA approvedtebentafusp-tebn (Kimmtrak, Immunocore), a bispecific T-cell engager designed to redirect the immune system to recognize and kill cancerous cells, for the treatment of adults with unresectable or metastatic uveal melanoma.

Tabentafusp-tebn is the first T-cell receptor (TCR) therapeutic to receive regulatory approval from the FDA and the first bispecific T-cell engager approved to treat a solid tumor, according to Immunocore. It also is the only therapy approved to treat this rare form of ocular melanoma, the company said.

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” noted investigator John Kirkwood, MD, the director of the Melanoma Center at UPMC Hillman Cancer Center, in Pittsburgh. “The approval … 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 was based on a phase 3 trial of 378 human leukocyte antigen (HLA)-A*02:01–positive adults who received tebentafusp-tebn or the investigator’s choice of therapy with single-agent pembrolizumab (Keytruda, Merck), ipilimumab (Yervoy, Bristol Myers Squibb) or dacarbazine, according to results published in The New England Journal of Medicine (2021;385[13]:1196-1206).

Overall survival at one year was 73% in the tebentafusp-tebn group and 59% in the control group (hazard ratio [HR] for death, 0.51; 95% CI, 0.37-0.71; P<0.001). Progression-free survival at six months was 31% in the tebentafusp-tebn group compared with 19% (HR for disease progression or death, 0.73; 95% CI, 0.58-0.94; P=0.01).

Serious adverse reactions include cytokine release syndrome; skin reactions such as rash, pruritus and cutaneous edema; and elevations in liver enzymes, Immunocore said. Other common side effects include fatigue, nausea, hypotension, dry skin, headache and vomiting.

For more information, see the full prescribing information for tebentafusp.

—David Doolittle

Based on press releases from the FDA and Immunocore.