Immunocore, EORTC announce enrollment of first patient in Phase 3 ATOM trial

The European Organisation for Research and Treatment of Cancer and Immunocore (IMCR) Holdings announced the randomization of the first patient in the Phase 3 Adjuvant Trial in Ocular Melanoma, investigating the safety and efficacy of tebentafusp as adjuvant treatment for uveal melanoma. The primary objective of the open-label, international, multicenter trial – led by EORTC – will be to assess whether tebentafusp can prevent or delay relapse in patients with primary ocular melanoma at high risk of relapse, as compared with observation. Tebentafusp is approved for the treatment of HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma in 38 countries, under the brand name KIMMTRAK. The trial is expected to enroll 290 HLA-A*02:01-positive patients with uveal melanoma who have undergone definitive treatment by surgery or radiotherapy. Eligible patients will be randomized 1:1 to one of two arms: tebentafusp (as monotherapy) for six months or until disease relapse, or observation. Secondary objectives include overall survival, safety and tolerability, while exploratory objectives include evaluation of circulating tumor DNA as a marker of residual disease, and a comparison of health-related quality of life.