Investigational agent improves survival in advanced RCC

An interim analysis of a phase III trial of patients with advanced renal cell carcinoma shows an estimated 39% improvement in survival in patients receiving the investigational drug sorafenib tosylate (Nexavar) compared with those receiving placebo (p=.018).

“These data build on the previously announced finding that disease progression was significantly delayed in advanced kidney cancer patients who received sorafenib,” said co-principal investigator Bernard Escudier, MD, of the Gustave-Roussy Institute, Paris.

This interim analysis was conducted soon after patients receiving placebo crossed over to treatment with sorafenib. The analysis was based on the 220 survival events that had occurred by May 31, 2005. The final survival analysis, which is planned when 540 events have occurred, is not expected for some time.

The phase III trial has shown that progression-free survival was doubled to a median value of 24 weeks in patients who received sorafenib, 400 mg twice a day, compared with 12 weeks in patients receiving placebo. In addition, 74% of sorafenib patients had tumor shrinkage compared with 20% of placebo patients. The rate of adverse events was comparable for both groups.