AVEO Oncology (AVEO) said on Wednesday that data from a phase 3 study of tivozanib in 350 patients with highly refractory metastatic renal cell carcinoma (RCC) demonstrated a “superior progression-free” (PFS) survival benefit.
Statistically significant improvements favoring tivozanib were reported for the primary endpoint of PFS and the secondary endpoint of overall response rate, according to a statement.
The company plans to submit a new drug application (NDA) Q1, 2020 and expects to report results from the final overall survival analysis in June 2020.
In the randomized, multi-center, and open-label study, tivozanib, the company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor, was compared with sorafenib. The superior PFS benefit was seen in patients with advanced or metastatic RCC who have failed at least two prior lines of therapy.