Pfizer Inc.announced 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.
Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit 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.