Earlier today Pfizer announced that the Phase III AXIS 1032 trial (A4061032), studying axitinib, also known as AG013736 [1], in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival (PFS) when compared to sorafenib (Nexavar?, Bayer Healthcare/Onyx Pharmaceuticals), in the study population. Consistent with previous analyses, axitinib demonstrated a generally manageable safety profile in this study.

The investigational compound axitinib is an oral, small molecule tyrosine kinase inhibitor under development by Pfizer Inc. The trial drug inhibits multiple targets, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3, which appear to have roles in tumor growth, vascular angiogenesis and metastatic progression of cancer. Axitinib also inhibits platelet derived growth factor receptor (PDGFR), and cKIT (CD117) and has been shown to significantly inhibit growth of breast cancer in xenograft models [2] and has been successful in trials with renal cell carcinoma (RCC) [3] and several other tumor types [4]. because axitinib is an investigational agent, it has not been approved by regulatory agencies.

Commenting on the trial results senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit Dr. Mace Rothenberg said: ?It is gratifying that in this trial axitinib provided significant benefit to patients with advanced RCC whose disease had progressed after 1st-line therapy. These results provide insight into the potential value of axitinib as part of a sequential treatment approach in patients with advanced RCC.We will work with health authorities to determine possible filing options for axitinib for use in patients with advanced RCC.”

Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC, the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20%.

Clinical Research Program
Pfizer announced that it will continue to investigate the potential role of axitinib across several tumor types, including a Phase 3 study of treatment-naive and previously treated patients with mRCC. Healthcare professionals who are interested in learning more about Pfizer Oncology clinical trials that are open for enrollment can visit the Pfizer Oncology website.. Patients with questions about participation in a clinical trial should contact their treating physician.

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[1] Kelly RJ, Rixe O., Axitinib (AG-013736). Recent Results Cancer Res. 2010;184:33-44.
[2] Wilmes LJ, Pallavicini MG, Fleming LM, Gibbs J, Wang D, et al. AG-013736, a novel inhibitor of VEGF receptor tyrosine kinases, inhibits breast cancer growth and decreases vascular permeability as detected by dynamic contrast-enhanced magnetic resonance imaging. Magn Reson Imagin . 2007 Apr;25(3):319-27. Epub 2007 Feb 5.
[3] Rini B, Rixe O, Bukowski R, Michaelson MD, Wilding G, Hudes G, Bolte O, Steinfeldt H, Reich SD, Motzer R. (2005) AG-013736, a multi-target tyrosine kinase receptor inhibitor, demonstrates anti-tumor activity in a Phase 2 study of cytokine-refractory, metastatic renal cell cancer (RCC). ASCO Proceedings Abstract 4509
[4] Rugo HS, Herbst RS, Liu G, Park JW, Kies MS, Steinfeldt HM, Pithavala YK, Reich SD, Freddo JL, Wilding G. (2005) Phase I trial of the oral antiangiogenesis agent AG-013736 in patients with advanced solid tumors: pharmacokinetic and clinical results. J Clin Oncol. 2005 Aug 20;23(24):5474-83. Epub 2005 Jul 18.

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