According to a Pharmalive report, tivozanib, an oral once-daily investigational tyrosine kinase inhibitor, demonstrated superiority over sorafenib in the primary endpoint of progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC).

The TIVO-1 study, a global, randomised Phase III study, evaluated the efficacy and safety of tivozanib versus sorafenib in 517 treatment-naïve patients with advanced clear cell RCC who had undergone a prior nephrectomy. The following findings were reported [no data on statistical significance were available within the Pharmalive abstract]:

• Tivozanib demonstrated an improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall study population

• Tivozanib demonstrated an improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib in the pre-specified subpopulation (70% of total study population) of patients who were treatment naïve (no prior systemic anti-cancer therapy).

• Tivozanib demonstrated a well-tolerated safety profile consistent with the Phase 2 experience; the most commonly reported side effect was hypertension.

Based on final analyses of these data, an application for marketing approval  of tivozanib in the United States and Europe is expected to be submitted in 2012.