Phase III IMCgp100-202 study of IMCgp100 shows statistical improvement in metastatic uveal melanoma.- Immunocore

Immunocore has announced trial results showing that overall survival (OS) was statistically significantly improved with IMCgp100 (tebentafusp) compared with investigator’s choice of therapy as treatment of patients with metastatic uveal melanoma in the phase III IMCgp100-202 study (NCT03070392). The study evaluated OS as the primary end point among patients with previously untreated metastatic uveal melanoma, in which 378 patients were split 2:1 to receive the study drug or investigator’s choice, which included either dacarbazine, ipilimumab (Yervoy), or pembrolizumab (Keytruda). Overall, the OS hazard ratio for tebentafusp over the other agents was 0.51 in the intention-to-treat population, and Kaplan-Meier analysis data, although not yet mature, estimate a 1-year OS rate of 73% for the study drug versus 58% with investigator’s choice. These data also confirm the benefit in OS observed in the phase II IMCgp100-102 clinical trial. Secondary end points included safety, objective response rate, duration of response, progression-free survival, and disease control rate, as well as some quality of life and pharmacokinetic end points. This bispecific protein consists of a soluble T-cell receptor fused to an anti-CD3 immune-effector function, and targets gp100, an antigen in melanocytes and melanoma. Tebentafusp is the first agent using ImmTAC technology platform that is designed to redirect and activate T-cells to kill tumor cells. Tebentafusp has received FDA Fast Track and Orphan Drug designations, plus Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme.