Pfizer's Phase 3 AXIS 1032 trial for metastatic renal cell carcinoma meets primary endpoint

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.