Tivozanib (AV-951) was well tolerated and improved median progression-free survival (PFS) in some patients with advanced renal cell carcinoma (RCC), according to the results of a phase II study published in the Journal of Clinical Oncology.

More than 58,000 people are diagnosed with kidney cancer in the United States each year. The most common type of kidney cancer is renal cell carcinoma (RCC). For people with metastatic RCC (cancer that has spread to other parts of the body), targeted therapies such as tivozanib can play an important role in treatment.

Tivozanib is an oral tyrosine kinase inhibitor that targets proteins responsible for stimulating cancer cell growth. Tivozanib blocks all three vascular endothelial growth factor (VEGF) receptors. VEGF plays a key role in the development of new blood vessels. By blocking VEGF, tivozanib deprives the cancer of nutrients and oxygen and inhibits its growth.

This phase II, randomized trial included 272 patients who received tivozanib for 16 weeks. After the initial 16 weeks, 78 patients who demonstrated tumor shrinkage greater than 25% continued to take tivozanib, while 118 patients with tumor shrinkage less than 25% were randomized to receive tivozanib or placebo. Patients who experienced tumor growth of 25% or more were discontinued from the study.

After 16 weeks of treatment, the objective response rate (ORR) for tivozanib was 18%. Of the 118 randomized patients, significantly more patients who were randomly assigned to receive double-blind tivozanib remained progression free after 12 weeks versus patients who received the placebo. PFS was 49% for patients who received tivozanib compared to 21% for those who received placebo. The most common grade 3 and 4 treatment-related adverse event was hypertension.

The researchers concluded that tivozanib is active against advanced RCC. The drug was well tolerated with minimal toxicities.


Nosov DA, Esteves B, Lipatov ON, et al. Antitumor activity and safety of tivozanib (AV-951) in a phase II randomized discontinuation trial in patients with renal cell carcinoma. Journal of Clinical Oncology. Published early online: April 9, 2012. doi: 10.1200/JCO.2011.35.3524

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