New targeted therapy drug shows longer PFS in kidney cancer

Thursday, 5 January 2012- Patients with advanced renal cell carcinoma had modestly longer progression-free survival when treated with tivozanib, an investigational targeted therapy, than with sorafenib (Nexavar) in a head-to-head randomised trial, according to the makers of tivozanib.

Median progression-free survival in the 517-patient phase III trial was 11.9 months with the new agent versus 9.1 months in those receiving sorafenib, according to a statement from Aveo Pharmaceuticals and Astellas Pharma, which are co-developing tivozanib.

A pre-specified subgroup analysis focusing on patients with no prior systemic anticancer therapy showed a slightly larger benefit with tivozanib -- median progression-free survival of 12.7 months as opposed to 9.1 months with sorafenib, the companies said. Both between-drug differences were described as statistically significant.

The firms did not announce results for previously treated patients, nor did they give data on overall survival. During a conference call with reporters and stock analysts, Aveo president Tuan Ha-Ngoc said full data would be submitted for presentation at the American Society of Clinical Oncology's annual meeting in June.

As in earlier trials, hypertension was the most common side effect, as has been noted for other inhibitors of vascular endothelial growth factor (VEGF) receptors.

Tivozanib blocks VEGF receptor subtypes 1, 2, and 3, as well as platelelet-derived growth factor-beta and a third cancer promoter known as cKIT.
All patients in the trial had clear-cell renal cell carcinoma with prior nephrectomy but no previous treatment with anti-VEGF or rapamycin-like drugs.

Aveo and Astellas indicated that they planned to submit US and European marketing applications for tivozanib later this year.

Source: MedPage Today

Edited by: JV


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