Immunocore Achieves Target Enrollment in TEBE-AM Trial for Advanced Melanoma

Immunocore, a biotechnology company developing innovative immunomodulating medicines, has announced the achievement of its target patient enrollment in the TEBE-AM clinical trial. This global, randomized, Phase 3 trial evaluates KIMMTRAK (tebentafusp) as a monotherapy and in combination with pembrolizumab for the treatment of HLA-A*02:01-positive patients with advanced melanoma whose disease has progressed following prior therapy.

The TEBE-AM trial, which has enrolled 540 patients, aims to assess the overall survival of these patients. The primary endpoint of the study is to determine the efficacy of KIMMTRAK in this specific patient population.

KIMMTRAK, a novel bispecific protein developed using Immunocore’s ImmTAC technology platform, specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This molecule has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in several countries, including the United States, European Union, Canada, Australia, and the United Kingdom.

The TEBE-AM trial is designed to evaluate the safety and efficacy of KIMMTRAK in patients with second-line or later advanced melanoma who have progressed on an anti-PD1 therapy, received prior ipilimumab, and, if applicable, have received a BRAF kinase inhibitor. The study comprises three arms: tebentafusp as monotherapy, tebentafusp in combination with an anti-PD-1, and a control arm.

Dar added, "We are grateful to the patients and investigators participating in the trial. With target enrollment now achieved, the patients enrolled will continue to be followed for the planned overall survival analysis. The Company believes tebentafusp has the potential to address a significant unmet need for up to 4,000 HLA-A*02:01-positive patients with previously treated advanced melanoma in the post-PD1 setting, in the United States and Europe."

Topline overall survival data from the TEBE-AM trial are expected as early as the end of 2026. Immunocore’s proprietary TCR technology generates a novel class of bispecific biologics called ImmTAC molecules, designed to redirect the immune system to recognize and kill cancerous cells. These molecules are engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function.

Cutaneous melanoma, the most common form of melanoma, is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. Despite recent progress in advanced melanoma therapy, there remains an unmet need for new therapies that improve first-line response rates and duration of response, as well as for patients who are refractory to first-line treatments.

The Company’s commitment to addressing this unmet need is reflected in its ongoing efforts to expand the approved indications for KIMMTRAK and to obtain marketing approval for the treatment of additional patient populations. Immunocore’s focus on developing transformative immunomodulating medicines underscores its dedication to radically improving outcomes for patients with cancer, infectious diseases, and autoimmune diseases.