KIMMTRAK with or without anti-PD1 therapy - (TEBE-AM)

September 14, 2026: Immunocore Holdings plc (NASDAQ: IMCR) said it achieved target enrollment of 540 patients in the registrational Phase 3 TEBE-AM trial (NCT05549297) of KIMMTRAK (tebentafusp) in previously treated advanced melanoma. The global randomized study is enrolling HLA-A*02:01-positive patients with advanced melanoma whose disease progressed after prior therapy; patients had progressed on anti-PD-1, received prior ipilimumab, and, if applicable, a BRAF inhibitor.

TEBE-AM is testing tebentafusp monotherapy and tebentafusp plus pembrolizumab/anti-PD-1 versus investigator’s choice. The primary endpoint is overall survival. With enrollment complete, patients will continue to be followed for the planned overall survival analysis, and the company expects topline overall survival data as early as the end of 2026.

The release frames this as a registrational trial aimed at a post-PD1 advanced melanoma setting with limited treatment options. It also notes KIMMTRAK is already approved in multiple regions for HLA-A*02:01-positive unresectable or metastatic uveal melanoma.