Immunocore Completes Enrollment in Registrational TEBE-AM Trial of KIMMTRAK in Advanced Melanoma
核心洞察
Immunocore (搜索) announced it has reached target enrollment in TEBE-AM, a Phase 3 registrational trial of tebentafusp in previously treated advanced melanoma (搜索).
The three-arm study enrolls patients with second-line or later advanced melanoma (搜索) who progressed on an anti-PD1 and received prior ipilimumab.
TEBE-AM evaluates tebentafusp monotherapy and tebentafusp plus an anti-PD-1 (搜索) against a control arm, with overall survival as the primary endpoint.
Immunocore (搜索) has announced achievement of target enrollment in TEBE-AM, a Phase 3 registrational trial evaluating KIMMTRAK (tebentafusp) in patients with previously treated advanced melanoma (搜索). The trial enrolls patients with second-line or later advanced melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF (搜索) kinase inhibitor.
TEBE-AM comprises three arms: tebentafusp as monotherapy, tebentafusp in combination with an anti-PD-1 (搜索), and a control arm. The primary endpoint is overall survival. Cutaneous melanoma (搜索), the most common form of melanoma, remains associated with the vast majority of skin cancer-related mortality, and the company notes an unmet need for therapies improving first-line response rates and duration of response, as well as for patients refractory to first-line treatments.
KIMMTRAK is a bispecific protein comprising a soluble T cell receptor fused to an anti-CD3 (搜索) immune-effector function that specifically targets gp100 (搜索), a lineage antigen expressed in melanocytes and melanoma. It is the first molecule developed using Immunocore (搜索)'s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells, and is approved for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma (搜索) in the United States, European Union, Canada, Australia and the United Kingdom. Labeled safety information includes cytokine release syndrome, reported in 89% of treated patients (0.8% grade 3 or 4), skin reactions in 91%, and elevated liver enzymes in 65%.
Source: Immunocore announces achievement of target enrollment in registrational TEBE-AM trial