Aveo reports Phase I data for ficlatuzumab in AML

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) reported data from 8 evaluable patients with relapsed or refractory acute myelogenous leukemia (AML) in a Phase I trial showing that IV ficlatuzumab (AV-299) plus high-dose IV cytarabine led to 4 complete responses. Ficlatuzumab was well tolerated with no dose-limiting toxicities (DLTs) reported. The most frequent grade 3/4 adverse events reported were febrile neutropenia, ventricular tachycardia, respiratory distress and electrolyte disturbance. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The open-label, U.S. trial evaluated 10, 15 and 20 mg/kg ficlatuzumab every 2 weeks for 4 doses per cycle plus cytarabine. The trial’s primary endpoints are DLTs and maximum tolerated dose (MTD). Secondary endpoints include preliminary antitumor activity, functional status, quality of life (QOL), overall survival (OS) and biomarkers...