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Immunocore Launches Phase III Trial of IMC-F106C, BMS's Opdivo in Cutaneous Melanoma

NEW YORK – Immunocore said on Thursday that a supply agreement with Bristol Myers Squibb will allow it to conduct a Phase III trial of the immune checkpoint inhibitor Opdivo (nivolumab) with its bispecific T-cell receptor candidate IMC-F106C in newly diagnosed advanced cutaneous melanoma patients.

Oxfordshire, UK-based Immunocore is sponsoring and funding the registrational trial, dubbed PRISM-MEL-301, and BMS is providing Opdivo for use in the study.

In the trial, Immunocore is testing IMC-F106C, which targets PRAME HLA-A02, plus Opdivo in roughly 680 patients with HLA-A*02:01-positive cutaneous melanoma. Patients will be randomized to receive either the IMC-F106C-Opdivo combination; Opdivo alone; or Opdualag (nivolumab and relatlimab) if this regimen is approved in the country where patients are enrolled. As a primary endpoint, Immunocore will measure patients' progression-free survival, and as secondary endpoints, it will evaluate overall response rates, overall survival, and safety.

Immunocore said it will begin enrolling patients into the study during the first quarter of 2024.

In 2022, the firm netted US Food and Drug Administration and European Commission approvals for Kimmtrak (tebentafusp), another T-cell receptor therapy, in HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.