Posted by Michael Wonder on 04 Apr 2019
Immunocore’s lead asset tebentafusp gains fast track designation for metastatic uveal melanoma
3 April 2019 - Immunocore today announces that the U.S. FDA has granted fast track designation for its development program, the investigation of tebentafusp (IMCgp100) for the treatment of patients who are HLA-A*0201-positive with previously untreated, metastatic uveal melanoma.
The pivotal study IMCgp100-202 is a 2:1 randomised study of tebentafusp compared with investigator’s choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with previously untreated metastatic uveal melanoma. The primary endpoint is a comparison of overall survival.
