Immunocore Partners with Bristol Myers Squibb for Phase 3 Melanoma Trial of IMC-F106C Combined with Nivolumab

Immunocore, a leading biotechnology firm, has forged a partnership with Bristol Myers Squibb to delve into a Phase 3 clinical trial. The focus of this trial is to assess the efficacy of a novel immunotherapy, IMC-F106C, in conjunction with Bristol Myers Squibb's nivolumab, for the treatment of advanced cutaneous melanoma.

IMC-F106C is a groundbreaking bispecific TCR ImmTAC molecule developed by Immunocore, designed to target the PRAME HLA-A02 protein. This therapy is set to be evaluated in the PRISM-MEL-301 trial, which is a pivotal Phase 3 study. The trial will compare the effects of IMC-F106C combined with nivolumab against either nivolumab alone or a combination of nivolumab and relatlimab, contingent on the patient's country of enrollment.

The collaboration stipulates that Immunocore will finance and oversee the PRISM-MEL-301 trial, while Bristol Myers Squibb will supply the nivolumab needed for the study. The trial is designed to include HLA-A*02:01 positive patients who have not yet received treatment for their advanced melanoma. Enrollment for the trial is expected to commence in early 2024.

The Phase 3 trial, identified by the registration number NCT06112314, will initially involve three arms: two different dosing schedules for IMC-F106C and a control group. The trial's primary focus will be on progression-free survival, as determined by a blinded independent central review. Additional endpoints include overall survival, overall response rate, and safety assessments.

Immunocore is renowned for its innovative TCR bispecific immunotherapies, known as ImmTAX, which are intended to address a variety of diseases, notably cancer, autoimmune disorders, and infectious diseases. The company has an extensive pipeline, featuring five clinical-stage programs in oncology and infectious disease, along with advanced pre-clinical programs for autoimmune conditions and several early-stage initiatives.

The company's flagship oncology product, KIMMTRAK, has received approval for treating HLA-A*02:01-positive adult patients with certain types of melanoma in several regions, including the United States, European Union, Canada, Australia, and the United Kingdom.

This collaboration signifies a significant step forward in the quest for more effective treatments for melanoma, a type of skin cancer that can be particularly aggressive. The combination of a novel immunotherapy with an established checkpoint inhibitor could potentially offer new hope to patients battling this disease.