Aveo falls on FDA concerns about tivozanib data

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) fell $3.55 (27%) to $9.75 on Thursday after saying FDA expressed concerns about the overall survival trend in the Phase III TIVO-1 trial comparing Aveo's tivozanib to sorafenib in renal cell carcinoma (RCC). Aveo, which hopes to submit an NDA this quarter, said it is conducting additional OS analyses to address the agency's concerns that could delay the submission into next quarter.

Aveo said the estimated one-year survival rate was 77% in the tivozanib arm compared to 81% in the sorafenib arm. About 53% of patients in the sorafenib arm have received subsequent therapy, including tivozanib, while about 17% of patients in the tivozanib arm have received subsequent therapy. The OS data are not yet mature. Aveo said it will conduct an analysis comparing tivozanib's estimated one-year survival rate to historical rates seen with approved agents, as well as an analysis of differences in utilization of subsequent therapies between the trial's arms (see BioCentury, Jan. 9). ...