Phase II trial of hu14.18-IL2 (EMD 273063) for patients with metastatic melanoma

9039 Background: The hu14.18-IL2 immunocytokine consists of a humanized anti-GD2 monoclonal antibody linked to IL2. It has potent preclinical activity against melanoma (MEL) and neuroblastoma (NBL), particularly in the setting of minimal residual disease (MRD). Recent Phase I trials of hu14.18-IL2 in patients (pts) with MEL or NBL showed immune activation, reversible toxicities, and a maximal tolerated dose of 7.5 mg/m2/d for MEL. Five MEL pts with non-evaluable disease showed long disease free survival (range: 6- > 106 months). A recently completed phase II study (separate ASCO abstract) for NBL showed antitumor activity in pts with MRD. Methods: All pts had measurable metastatic MEL. Hu14.18-IL2 was given at 6 mg/m2/d as a 4h i.v. infusion on d 1, 2, and 3 of each 28d treatment cycle. Pts with stable disease (SD) or regression following cycle 2 were eligible to receive 2 additional cycles of therapy. The primary study objective was to evaluate clinical anti-tumor activity and duration of response, and s...