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Aveo's kidney cancer drug tivozanib on track for 2012 filing

Study demonstrates improved progression-free survival in patients with advanced renal carcinoma

Aveo Pharmaceuticals and partner Astellas say they plan to file for approval of advanced renal carcinoma (RCC) drug tivozanib in the third quarter of 2012.

The companies have just published the results of a phase II trial of tivozanib in the Journal of Clinical Oncology, with results showing that the drug was more effective in shrinking tumours and improving progression-free survival (PFS) compared to placebo.

The 272-patient study revealed that 49 per cent of patients on tivozanib were progression-free after 12 weeks' treatment, compared to 21 per cent of the placebo group. Aveo's drug was also well tolerated with "minimal off-target toxicities", according to the company.

Tivozanib is an oral drug in the vascular endothelial growth factor (VEGF) receptor inhibitor class, which is currently represented on the market by Bayer's Nexavar (sorafenib), GlaxoSmithKline's Votrient/Patorma (pazopanib) and Pfizer's Sutent (sunitinib) and Inlyta (axitinib).

Earlier this year, Aveo reported positive results from a phase III trial of tivozanib - called TIVO-1 - which showed that its drug was superior to Nexavar in achieving PFS among patients treated first-line for advanced RCC.

"Despite recent progress in treating patients with RCC, patients and physicians would benefit from a new RCC treatment option that delivers both improved efficacy and a more tolerable safety profile," said Dmitry Nosov of the Blokhin Oncology Research Centre in Moscow, the lead author for both tivozanib studies.

Astellas licensed worldwide rights outside Asia to tivozanib in February 2011 for an upfront payment of $125m and up to $1.3bn in clinical, regulatory and commercial milestones. The drug is licensed to Kyowa Hakko Kirin in Asia.

At around the time the licensing deal was announced, analysts at Decision Resources suggested that peak sales of the drug would be modest at somewhere between $100m and $250m a year, given that it is likely to be a fairly late entrant into the RCC market.

13th April 2012

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