Aveo reports Phase I data for ficlatuzumab in SCCHN

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) reported data from 12 evaluable patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who were refractory to cetuximab in a Phase I trial showing that IV ficlatuzumab (AV-299) every 2 weeks plus cetuximab led to an overall response rate (ORR) of 17%, including 2 partial responses. There were 6 cases of stable disease for a disease control rate (DCR) of 67%. At the recommended Phase II dose of 20 mg/kg ficlatuzumab plus 500 mg/m² cetuximab every 2 weeks, median progression-free survival (PFS) was 6 months and median overall survival (OS) was 8.2 months. No dose-limiting toxicities (DLTs) were reported. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The primary endpoint of the open-label, U.S. trial was to determine the recommended Phase II dose. Secondary endpoints include PFS, ORR, OS, biomarkers, pharmacokinetics, dendritic and T cell phenotypes, DLTs and quality of life (QOL)...