Newly Listed Immunocore's Tebentafusp Receives Breakthrough Therapy Tag For Eye Cancer

The FDA has designated Breakthrough Therapy status to Immunocore Holdings PLC's (NASDAQ: IMCR) tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive in adult patients with unresectable or metastatic uveal melanoma (mUM), cancer of the eye involving the iris, ciliary body, or choroid.
In an initial pre-planned interim analysis of Phase 3 trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, tebentafusp demonstrated superior overall survival benefit as a monotherapy. The primary endpoint was achieved when the OS Hazard Ratio in the intent-to-treat population favored tebentafusp, over the investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).
Tebentafusp has also been granted Fast Track and Orphan Drug designations from FDA for uveal melanoma and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme.
The company started trading on NASDAQ earlier this month.
Price Action: IMCR shares are trading higher by 4.38% at $50.10 in the premarket session on the last check Friday.