Immunocore Plans Phase II/III Uveal Melanoma Trial
Early results show a combination therapy with Kimmtrak and brenetafusp, with a randomised study planned for patients with advanced uveal melanoma.
Updated on Nov. 6, 2026 in Cancer
Immunocore presented early results on Friday at the Society for Immunotherapy of Cancer annual meeting, reporting data for a combination of its marketed drug Kimmtrak with the investigational T-cell engager brenetafusp in unresectable or metastatic uveal melanoma. The company plans to launch the randomised Phase II/III DUET-UVEAL study.
Why it matters
Kimmtrak has been approved since 2022 for HLA-A*02:01-positive adults with uveal melanoma, and the combination approach targets both gp100 and PRAME, an antigen associated with poor prognosis. Targeting both antigens offers the potential for greater benefit in HLA-A*02:01-positive patients.
The early Phase I/II study enrolled small numbers, with 17 evaluable first-line combination patients showing a 29% overall response rate and a 24.1-month median duration of response. Results from the planned randomised DUET-UVEAL study, which will compare outcomes against established care, have not yet been reported.
The players
Immunocore
Immunocore is a biotechnology company developing ImmTAC T-cell receptor therapies, including the marketed drug Kimmtrak for uveal melanoma.
Society for Immunotherapy of Cancer
The Society for Immunotherapy of Cancer is an international professional organization that holds an annual meeting for researchers and clinicians working on cancer immunotherapy.
The details
Immunocore is combining Kimmtrak (tebentafusp), which targets gp100, with brenetafusp, which targets PRAME, in patients with unresectable or metastatic uveal melanoma. The company reported these combination and monotherapy results at the Society for Immunotherapy of Cancer annual meeting and plans to launch DUET-UVEAL as a randomised Phase II/III study.
Timeline
2022: Kimmtrak received approval for HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma.
Friday: Immunocore presented early combination and brenetafusp monotherapy results at the SITC annual meeting.
Health Landscape
Kimmtrak became the first therapy approved for metastatic uveal melanoma in 2022, a disease with historically limited treatment options. The combination with brenetafusp represents an effort to build on that approval by targeting an additional antigen linked to poor prognosis.
For patients with unresectable or metastatic uveal melanoma, the combination approach is still investigational and is not available outside clinical trials. Kimmtrak remains the approved option for HLA-A*02:01-positive adults.
The takeaway
Combining immunotherapies that target different tumor antigens may offer a path to deeper responses in uveal melanoma, but the randomised DUET-UVEAL results will be needed to confirm any benefit over current treatment.
What happens next
Immunocore plans to launch the randomised Phase II/III DUET-UVEAL study, though no specific start date was provided in the source extraction.
Further reading
For broader context on treatment advances, see the Cancer section.
Source note: This article includes information reported by Firstwordpharma.
