Italian biotechnology firm Philogen has secured investigational new drug (IND) approval from the US Food and Drug Administration (FDA) to conduct a Phase III registration trial of Daromun (L19IL2 + L19TNF) to treat patients with melanoma.
Daromun is an immunocytokine product being developed to be administered as a neoadjuvant treatment through intratumoural route in patients who have a minimum of one injectable cutaneous, sub-cutaneous or lymph node metastasis and could undergo complete metastases resection.
The open-label, randomised, controlled, multi-centre Phase III trial will assess the efficacy of Daromun as neoadjuvant intratumoural treatment before surgery compared to surgery alone in a total of 248 patients with fully resectable stage IIIB or IIIC melanoma.
Currently, the trial is being conducted in Italy, Germany, and Poland, with results scheduled to be available in 2020.
The trial will be led by Moffitt Cancer Centre Surgery professor and Regional Therapies Programme director Jonathan Zager in the US.
Philogen co-founder and Scientific Advisory Board president professor Dr Dario Neri said: “Daromun combines a number of desirable characteristics such as good tolerability and efficacy that make it an exciting and promising immunotherapy for the treatment of resectable melanoma.”
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The primary outcome measure of the trial is the rate of recurrence-free survival (RFS) at one year after enrolment into the trial.
Additionally, the trial will measure secondary outcomes such as local recurrence-free survival (LRFS), distant metastasis-free survival (DMFS) and recurrence-free survival (RFS) rates, overall survival (OS), adverse events (AEs) and serious AEs, and human anti-fusion protein antibodies (HAFA).