OXFORDSHIRE, England & CONSHOHOCKEN, PA & ROCKVILLE, MD - Immunocore Holdings plc (NASDAQ:IMCR), a biotechnology company focused on developing immunotherapies for cancer and other diseases, announced the conversion of its TEBE-AM clinical trial from Phase 2/3 to a registrational Phase 3 trial.
This decision comes after recent consultations with the U.S. Food and Drug Administration (FDA) and is aimed at evaluating the efficacy of KIMMTRAK (tebentafusp-tebn) for advanced cutaneous melanoma treatment.
The Phase 3 trial will continue with three arms: KIMMTRAK monotherapy, KIMMTRAK in combination with pembrolizumab, and a control arm. The primary endpoint of the study is overall survival. Immunocore's decision to proceed directly to Phase 3 was influenced by the rapid patient accrual and the potential to accelerate the time to the final overall survival analysis. All patients randomized from the start of the trial will be included in the Phase 3 intent-to-treat population.
Mark Moyer, SVP of Regulatory Affairs at Immunocore, stated that the move to a Phase 3 registrational study is based on the observed overall survival benefit of KIMMTRAK in uveal melanoma and promising results from earlier phase trials in cutaneous melanoma. The trial is designed to provide robust testing for KIMMTRAK as both a monotherapy and in combination with other immune checkpoint therapies.
KIMMTRAK targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform. This technology is designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has already been approved for the treatment of unresectable or metastatic uveal melanoma in several regions, including the United States and the European Union.
Cutaneous melanoma is the most aggressive form of skin cancer, with a high mortality rate associated with metastatic disease. Despite advances in therapy, there remains an unmet need for treatments that improve response rates and duration, especially for patients who are refractory to first-line treatments.
This trial expansion is part of Immunocore's broader effort to develop a pipeline of treatments for a range of diseases, leveraging its proprietary TCR technology. The company's progress in the clinical development of KIMMTRAK for cutaneous melanoma is based on a press release statement and represents a significant step in addressing the needs of patients with advanced forms of this disease.
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