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.
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