The European Commission (EC) has approved Immunocore Holdings plc's (NASDAQ:IMCR) Kimmtrak (tebentafusp) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
- Kimmtrak is a novel bispecific protein comprised of a soluble T cell receptor that is fused to an anti-CD3 immune-effector function.
- The EC approval follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in February 2022.
- The CHMP recommendation of Kimmtrak is based on the results of Immunocore's Phase 3 IMCgp100-202 clinical trial.
- Related: FDA Approves First T Cell Receptor Therapy From Immunocore For Eye Cancer.
- Kimmtrak demonstrated a median overall survival benefit as a first-line treatment.
- The OS Hazard Ratio (HR) in the intent-to-treat population favored Kimmtrak, HR=0.51, over the investigator's choice of treatment (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine).
- In this study IMCgp100-202, 43% of patients received treatment beyond progression with tebentafusp with no new safety signals identified.
- Price Action: IMCR shares are up 4.32% at $32.39 during the market session on the last check Monday.
