Immunocore announces randomization of first patient in Phase 3 brenetafusp trial

Immunocore Holdings announces randomization of the first patient in the PRISM-MEL-301 trial, assessing the efficacy and safety of brenetafusp, in combination with nivolumab, in first-line advanced or metastatic cutaneous melanoma. The Phase 3 trial will randomize HLA-A*02:01 positive patients with first-line, advanced or metastatic cutaneous melanoma to brenetafusp + nivolumab versus a control arm of either nivolumab or nivolumab + relatlimab, depending on country. Bristol Myers Squibb will provide nivolumab. The Company has shared the cutaneous melanoma Phase 1 data during an oral presentation at the 2024 American Society of Oncology Annual Meeting on 31 May. The data showed that brenetafusp was well tolerated as monotherapy and in combination with anti-PD1, and demonstrated promising monotherapy clinical activity, including disease control rate, progression free survival, and circulating tumor DNA molecular response. Brenetafusp is the first PRAME x CD3 ImmTAC bispecific protein targeting an HLA-A*02:01 PRAME antigen. The Company is continuing to enroll patients into a Phase 1/2 trial in monotherapy and combination arms across multiple tumor types, including three expansion arms for patients with advanced ovarian, non-small cell lung, and endometrial cancers.