The previously published Phase II study NCT00658437 in patients with metastatic skin cancer (melanoma) (Trefzer et al. 2014) was subjected to an extended evaluation, because a relationship between the occurrence of local skin reactions after subcutaneous injection of ME-503 and the clinical effect of the treatment was considered possible. The extended evaluation thus referred to the phase II data of the patient cohorts with/without skin reactions within the first treatment cycle after SC injection.
There was a highly significant difference in median overall survival in patients with injection site reactions compared to patients without skin reactions.
Preliminary conclusions from our small cohorts indicate a robust clinical impact of ME-503 in patients with previously treated metastatic melanoma when these patients experience injection site reactions as adverse events after SC injection within the first course of treatment. Patients without injection site reactions appeared to have no clinical benefit from the therapy.