FDA Approves First T Cell Receptor Therapy From Immunocore For Eye Cancer

The FDA has approved Immunocore Holdings plc (NASDAQ:IMCR) (tebentafusp-tebn) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

• Marketed as Kimmtrak, approval highlighting a series of firsts: 
  • First TCR therapeutic to receive FDA approval, 
  • First bispecific T cell engager to receive FDA approval to treat a solid tumor.
  • The first and only therapy for unresectable or metastatic uveal melanoma to be approved by the FDA.
• Related: Immunocore Tebentafusp Shows Survival Benefit In Untreated Eye Cancer Patients.
• The approval is based on Phase 3 IMCgp100-202 trial results. 
• Data showed that Kimmtrak demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored Kimmtrak, HR=0.51, over investigator's choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). 
• Price Action: IMCR shares are up 9.53% at $24.02 during the premarket session on the last check Wednesday.