Horizon scanning: Phase III study on elesclomol for advanced melanoma fails to meet primary endpoint of progression-free survival

Source: Journal of Clinical Oncology Area: News According to the phase III study SYMMETRY published early online in the Journal of Clinical Oncology, elesclomol added to paclitaxel does not improve progression-free survival in patients with advanced melanoma.   The study involved a total of 651 patients with stage IV chemotherapy-naive melanoma who were randomised to receive paclitaxel 80 mg/m2 either alone or in combination with elesclomol 213 mg/m2 administered weekly for 3 weeks of a 4-week cycle. Patients were stratified by prior systemic treatment, M1 subclass, and baseline lactate dehydrogenase (LDH) levels. The primary end point was progression-free survival (PFS).   The study did not achieve its PFS end point (hazard ratio, 0.89; P = 0.23). The study was stopped when an early overall survival data analysis indicated an imbalance in total deaths favouring paclitaxel, predominantly in patients with high LDH levels. A prospectively defined subgroup analysis revealed a statistically significant ...
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news