Aveo falls on tivozanib OS data

Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) fell $0.54 to $7.35 on Wednesday after reporting that once-daily oral tivozanib missed the secondary endpoint of median overall survival (OS) vs. Nexavar sorafenib in the Phase III TIVO-1 trial to treat advanced renal cell carcinoma (RCC). In the 517-patient trial, tivozanib led to a median OS of 28.8 months vs. 29.3 months for Nexavar (p=0.105). Aveo said it believes that the "high" rate of utilization of second-line anti-VEGF therapy in patients following disease progression on Nexavar impacted the OS outcome. Of the 158 patients in the Nexavar arm who received subsequent anti-VEGF therapy after disease progression, 156 received tivozanib, an inhibitor of VEGF receptors 1, 2 and 3. Data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in Orlando.

Last year, Aveo said tivozanib met the primary endpoint of improving median progression-free survival (11.9 vs. 9.1 months, p=0.042) and the secondary endpoint of improving overall response rate (33% vs. 23%, p=0.014) vs. Nexavar. In August, Aveo said FDA expressed concerns about the OS trend in the trial. At the time, the company said the estimated one-year survival rate was 77% in the tivozanib arm compared to 81% in the Nexavar arm (see Biocentury Extra, Aug. 2, 2012). ...