ORLANDO, Fla. -- Trial findings from
for the experimental drug sorafenib confirmed interim phase III results in progression-free survival of advanced renal cell carcinoma.
As assessed by an independent review, progression-free survival was doubled to a median of 24 weeks in patients receiving sorafenib, vs. 12 weeks for patients receiving the placebo.
Shares of Onyx were hammered ahead of the bell Monday after a downgrade by Wachovia analysts, who say the good news is already in the stock. The success of a competing drug from
also pressured the shares, which were recently down $3.55, or 11%, to $28.30.
The data were discussed at the annual meeting of the American Society of Clinical Oncology.
Kidney cancer is resistant to most cancer drugs, but sorafenib stopped or shrank growing tumors in trials comparing the drug and a placebo, researchers said. Sorafenib is running neck and neck in the race to Food and Drug Administration approval with Pfizer's
experimental drug Sutent. Some analysts expect Sutent to come to market under another indication in this year's fourth quarter, then gain label expansion to include kidney cancer in early 2006.
Pfizer inherited Sutent after its 2002 acquisition of Pharmacia. The product is also in trials for stomach cancer.
Based on the positive interim results, Bayer and Onyx plan to file for FDA approval of the treatment.