Aveo Pharmaceuticals and Astellas Pharma are looking at filings for their kidney cancer treatment tivozanib later this year, after unveiling late-stage data showing a favourable survival profile over Bayer and Onyx's Nexavar.
Findings from the 517-patient TIVO-1 Phase III trial revealed that tivozanib demonstrated superiority over Nexavar (sorafenib) in the primary endpoint of progression-free survival (PFS) in patients with advanced renal cell carcinoma. Top-line analysis showed that patients on Aveo's drug had a median PFS of 11.9 months versus 9.1 months for Nexavar.
Aveo chief executive Tuan Ha-Ngoc said he was particularly pleased with the PFS benefit demonstrated in the treatment-naive population, "which represents the most significant market opportunity". In the latter group of patients, which accounted for around 70% of the total study population, tivozanib reached a median PFS of 12.7 months compared to 9.1 months for sorafenib.
Based on the data, the full set for which will be presented at the American Society of Clinical Oncology meeting in Chicago in June, Aveo and Astellas will submit tivozanib in the USA and Europe in 2012. The Japanese firm paid $125 million upfront for worldwide rights outside of Asia to tivozanib in February 2011 and Steven Ryder, president of Astellas Pharma Global Development, noted that the drug is "an important asset to our strategy of becoming a global category leader in oncology".
The companies are also looking to develop tivozanib in colorectal cancer and other solid tumours.