Immunocore Holdings plc (IMCR), a commercial-stage biotechnology company, on Sunday reported positive new Phase 1/2 data for Brenetafusp in treating advanced cutaneous melanoma. The results were presented at the 2026 American Society of Clinical Oncology (ASCO) annual meeting.
Brenatafusp (IMC-F105C) is an immune-mobilizing monoclonal T cell receptor against cancer, developed as part of the company's ImmTac platform. The drug targets tumor cells that are positive for the PRAME antigen.
Cutaneous melanoma is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. There are presently no approved alternative therapies for patients showing resistance to first-line treatment. The Phase 1/2 trial was carried out on 66 patients with heavily pretreated advanced melanoma, administering brenetafusp at 20-320 mcg doses. Those on brenetafusp monotherapy showed a median overall survival (OS) of 14.3 months, with an OS rate at 6 months of 87%, and an OS rate at 12 months at 57%. Additionally, the disease control rate (DCR) was recorded at 52%. The overall response rate (ORR) was 12%, improved at the dose of 160 mcg.
Patients who showed previous PD-1 resistance demonstrated a median OS of 14.7 months, and a circulation DNA (ctDNA) response of 53%, improved from the 38% ctDNA response of the rest of the group. Patients on brenetafusp in combination with pembrolizumab showed a higher ORR and DCR.
The company is also advancing brenetafusp in the ongoing Phase 3 PRISM-MEL-301 trial for the treatment of cutaneous melanoma. Based on the new data, the upcoming Phase 3 trial will administer a 160 mcg dose of brenetafusp in combination with nivolumab.
Another Phase 1/2 trial is investigating brenetafusp for non-small cell lung cancer (NSCLC) and ovarian cancer.
IMCR closed Friday at $28.89, down 0.28%.
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