Sutent is so well established as the favorable 1st line in RCC and very potent in this setting that I think it would be a mission impossible for Onyx to make inroads in kidney cancer.
›Pfizer Announces Positive Phase 3 Trial Results for Axitinib in Patients With Previously-Treated Metastatic Renal Cell Carcinoma (mRCC)
Detailed Study Results Expected to be Presented at an Upcoming Medical Meeting
Friday November 19, 2010, 7:55 am EST
NEW YORK, Nov. 19, 2010 /PRNewswire-FirstCall/ -- Pfizer Inc. (NYSE:PFE ) announced today that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib 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, in the study population. Consistent with previous analyses, axitinib demonstrated a generally manageable safety profile in this study.
"It is gratifying that in this trial axitinib provided significant benefit to patients with advanced RCC whose disease had progressed after 1st-line therapy," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "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 percent.
About the Investigational Agent Axitinib
Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. VEGF receptors 1, 2 and 3 appear to have roles in tumor growth, vascular angiogenesis and metastatic progression of cancer (the spread of tumors). Axitinib is an investigational agent and has not been approved by regulatory agencies.
Axitinib Clinical Research Program
Pfizer continues 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.‹
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