Astellas, AVEO announce positive results from TIVO-1 advanced RCC study

The investigational agent (tivozanib) has demonstrated statistically significant and clinically meaningful progression-free survival (PFS) superiority versus an approved targeted agent (sorafenib) in advanced RCC.

AVEO Oncology president and CEO Tuan Ha-Ngoc said the company believes that tivozanib may play a significant role in improving the treatment of patients with advanced kidney cancer.

"Together with our partner Astellas, we look forward to the next steps in our registration process and are continuing our preparations for the planned commercialization of tivozanib," Ha-Ngoc added.

The performance status and other prognostic indicators of 517 patients randomized in the Phase III superiority clinical trial were consistent with other pivotal trials in first-line advanced RCC.

Study results demonstrated favorable tolerability as evidenced by a distinctively low rate of dose interruptions and reductions, the company said.