Tivozanib (Astellas) success in TIVO-1 study for Renal Cell Carcinoma

Tivozanib from Astellas/Aveo Pharma is the first treatment to demonstrate greater than one year median PFS in treatment naive patients with metastatic Renal Cell Carcinoma (pre-specified sub-analysis). Treatment with tivozanib resulted in the longest reported median PFS to date in TIVO-1 study, a pivotal study: 12.7 months compared to a median PFS of 9.1 months for sorafenib.( HR = 0.756, p=0.0371). In patients who were pre-treated with systemic therapy, including cytokines (30% of the study population), tivozanib demonstrated an improvement in median PFS of 11.9 months compared with a median PFS of 9.1 months for sorafenib.The efficacy advantage of tivozanib over sorafenib was consistent across subgroups in the study (HR = 0.797, p=0.042) The objective response rate (ORR) for tivozanib was 33% compared to 23% for sorafenib (p=0.014). Tivozanib was generally well-tolerated, demonstrating a combination of superior efficacy and tolerability along with a lower rate of dose interruptions and reductions. The most common reported side effect for Tivozanib was hypertension, common with VEGFR inhibitors. The most common side effect of sorafenib was hand foot syndrome. The rate of dose interruption due to adverse events was 18% with tivozanib and 35% for sorafenib.