Immunocore’s tebentafusp demonstrates superior overall survival compared to investigator’s choice in a Phase 3 clinical trial of patients with previously untreated metastatic uveal melanoma
The primary endpoint of Overall Survival favored tebentafusp with a Hazard Ratio = 0.51 (95% CI: 0.36, 0.71), p< 0.0001 at the first pre-planned interim analysis conducted by the independent Data Monitoring Committee
First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor
Tebentafusp has the potential to be the first new therapy to improve OS in patients with metastatic uveal melanoma in 40 years
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 23 November 2020) Immunocore (the “Company”), a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune, today announced that its Phase 3 IMCgp100-202 clinical trial of tebentafusp (IMCgp100) vs. investigator choice in metastatic uveal melanoma (mUM) has met the pre-defined boundaries for statistical significance of the primary endpoint of Overall Survival (OS) in its first pre-planned interim analysis conducted by the independent data monitoring committee. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Although not yet mature, the Kaplan-Meier estimates suggest a 1-year OS rate of approximately 73% vs 58%, respectively. The efficacy data confirm the promising OS observed in the phase 2 study IMCgp100-102 in previously treated mUM which will be presented next month at the ESMO Immuno-Oncology Virtual Congress 2020.