New FDA-Approved Targeted Therapy for Advanced Kidney Cancer Tested in U of M Clinical Trials

MINNEAPOLIS/ST. PAUL (April 8, 2009) – A new drug, which was studied in clinical trials at the Masonic Cancer Center, University of Minnesota and has been approved by the U.S. Food and Drug Administration, may help some patients with advanced kidney cancer live longer.

Arkadiusz (Arek) Dudek, M.D., medical oncologist specializing in kidney cancer research and treatment at the University of Minnesota’s Masonic Cancer Center and Medical School, led the phase III clinical trial at the University to evaluate the effectiveness of the drug in patients. 

The drug, named Afinitor, is the first approved once-daily oral therapy that continuously targets mTOR, a protein inside the cancer cell that controls tumor cell division and blood vessel growth. It is one of the new cancer drugs classified as targeted therapies that hone in on the source of the cancer and do not adversely affect the rest of the body.

The manufacturer of the drug, Novartis Pharmaceuticals, sponsored the phase III clinical trial. Participants included 416 patients with advanced kidney cancer who did not respond to initial treatment with sunitinib or sorafenib.

FDA approval was based on data showing that Afinitor, when compared with placebo, more than doubled the time without tumor growth or death in patients with advanced kidney cancer (4.9 vs 1.9 months) and reduced the risk of disease progression or death by 67 percent. The data also showed that after 10 months of treatment, approximately 25 percent of patients still had no tumor growth.

“This new drug offers an additional option for patients whose advanced kidney cancer has not responded to the antiangiogenic drugs – drugs that cut off the blood supply to the tumor – commonly used for first line treatment of the disease,” Dudek said. “It is an exciting drug because no other therapy has been shown to improve progression-free survival in this setting. It also is a pill taken by mouth so patients do not need to come to the clinic to get it, and it is well tolerated with few side effects.”  

Kidney cancer – also called renal cell carcinoma – is diagnosed in about 54,000 people each year in the United States; more than 600 of those people are Minnesotans. More than 13,000 people die from kidney cancer annually; more than 200 of those people live in Minnesota. The rates of kidney cancer are rising in the world due in part to smoking and obesity.

In addition to the Masonic Cancer Center, other National Cancer Institute-designated comprehensive cancer centers conducting this clinical trial included Memorial Sloan-Kettering Cancer Center, Duke University Cancer Center, University of Pittsburgh, MD Anderson, and University of North Carolina Lineburger Cancer Center.  Prior to this drug, no other therapy had been studied in a phase III trial of patients with advanced kidney cancer.

Masonic Cancer Center, University of Minnesota is part of the University’s Academic Health Center. It is designated by the National Cancer Institute as a comprehensive cancer center for cancer research, treatment, and education. For more information, call 612-624-2620 or visit www.cancer.umn.edu. 

Contact:  
Mary Lawson, Masonic Cancer Center, 612-624-6165, mlawson@umn.edu
Sara Martin, Academic Health Center, 612-626-7037, buss@umn.edu