Astellas Pharma Europe Ltd. and AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) announced today that tivozanib, a novel once-daily oral tyrosine kinase inhibitor, successfully achieved its primary endpoint of improved median progression-free survival (PFS) in patients with advanced renal cell carcinoma (RCC).
Based on the top-line analysis of events in TIVO-1, determined by a blinded, independent review committee, key findings include:
- tivozanib was superior to sorafenib, demonstrating a statistically significant improvement in PFS with a median PFS of 11.9 months compared to a median PFS of 9.1 months for sorafenib in the overall study population
- tivozanib demonstrated a statistically significant improvement in PFS with a median PFS of 12.7 months compared to a median PFS of 9.1 months for sorafenib in the pre-specified subpopulation of patients who were treatment naĂŻve; this subpopulation was approximately 70% of the total study population
- tivozanib demonstrated a well-tolerated safety profile consistent with prior analyses; the most commonly reported side effect was hypertension, a well established on-target effect of Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors
TIVO-1 is a global, randomised phase III superiority clinical trial evaluating the efficacy and safety of the investigational drug tivozanib compared to the approved treatment sorafenib, in 517 patients with advanced RCC. All patients in TIVO-1 had clear cell RCC, had undergone a prior nephrectomy, and had not previously been treated with a targeted therapy.
RCC is the most common form of kidney cancer and the most aggressive of urologic cancers, representing 2-3% of all cancers worldwide. In 2008, there were an estimated 88,400 new cases and 39,300 kidney cancer-related deaths from RCC in Europe. However, 40% of patients will be diagnosed in the advanced stages when prognosis is extremely poor and the cancer is known to be difficult to treat.
â€śWeâ€™ve made big advances in the treatment of advanced kidney cancer over the last decade. Unfortunately, these advances can come at a cost of significant toxicity to patients,â€ť said Professor Tim Eisen, Professor of Medical Oncology, Addenbrooke's Hospital, Cambridge and TIVO-1 investigator. â€śThese data are exciting for patients with advanced kidney cancer because they demonstrate that tivozanib is an effective treatment which is well-tolerated in the large majority of patients.â€ť
Tivozanib works by blocking the vascular endothelial growth factor (VEGF) pathway, which plays a role in the formation of blood vessels that feed tumours. Tivozanib is a potent and selective inhibitor of all three VEGF receptors (VEGFRs) and has demonstrated in phase I studies the potential to be effectively combined with other treatments in RCC and other indications.
Study participants continue to be followed to gather additional data for further analyses. Complete findings from TIVO-1 will be submitted for presentation at the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 1-5, 2012 in Chicago.
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Last updated on: 05/01/2012