Immunocore’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma

Source: Business Wire, May 2019

OXFORD, England & CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (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 (mUM).

The pivotal study IMCgp100-202 is a 2:1 randomized study of tebentafusp compared with Investigator’s Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A*0201 positive adult patients with previously untreated mUM. The primary endpoint is a comparison of overall survival.

“For patients with metastatic uveal melanoma, the prognosis is poor and has not meaningfully changed in decades. Our goal is to test whether tebentafusp can prolong survival for these patients.” comments David Berman, Head of R&D of Immunocore. “We are delighted that tebentafusp has been granted Fast Track Designation.”