Novel Immunotherapy Tebentafusp Granted Fast Track Designation for Metastatic Uveal Melanoma

Source: Targeted Oncology, May 2019

The FDA has granted tebentafusp (IMCgp100) a fast track designation for the treatment of patients with HLA-A*0201-positive previously untreated metastatic uveal melanoma, according to Immunocore Limited, the company developing the novel immunotherapy agent.

In findings from a phase I study, tebentafusp demonstrated an overall survival (OS) rate of 74% at 1 year in patients with heavily pretreated metastatic uveal melanoma. At a median follow-up of 15.9 months, the median OS had not yet been reached.

Sixty-six percent of patients (95% CI, 39%-83%) remained alive and progression-free at 1 year by immune-related response criteria.