Updated Overall Survival Analysis Presented on Sorafenib Trial

Dr. Tim Eisen provided an update on the sorafenib (Nexavar) phase III trial in patients with advanced renal cell carcinoma (RCC), or kidney cancer, during the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Dr. Eisen is the consultant medical oncologist at The Royal Marsden Hospital in London. The updated analysis confirmed that overall survival was longer for sorafenib than for placebo patients.

The updated data showed a continued improvement in overall survival of 19.3 months for sorafenib recipients vs 15.9 months for patients given placebo (P = .015, hazard ratio [HR] = 0.77) despite the fact that 48% of placebo patients crossed over to sorafenib. Dr. Eisen also reported an overall survival of 19.3 months for sorafenib vs 14.3 months for placebo (P = .010, HR = 0.74) after censoring the placebo patients. These data, while they did not reach the prespecified result required to stop the overall survival analysis early, suggest a favorable survival trend for patients who received sorafenib. In April 2005, the trial was unblinded and patients who were receiving placebo could crossover to treatment with sorafenib based on the clinical and statistical significance of a definitive analysis of progression-free survival. The final analysis of overall survival is planned when 540 events are observed.

"Consistent with the original interim analysis, patients receiving Nexavar lived longer than patients receiving placebo, despite almost 50% of placebo patients crossing over to Nexavar," said Dr. Eisen. "These data are encouraging and should be considered preliminary pending the final analysis," said Dr. Eisen.

Quality-of-Life Data

An evaluation of health-related quality of life and symptoms of the phase III patient population was also presented at ASCO. In the study, sorafenib demonstrated a clinical benefit (as evidenced by progression-free survival) without adversely affecting overall quality of life, and had a positive impact on individual symptoms, such as cough, fevers, shortness of breath, worry that the condition will worsen, and ability to enjoy life.

"Quality of life is such an important issue for kidney cancer patients, as many of them do not have evident disease symptoms," said Bill Bro, president of the Kidney Cancer Association. "Today, patients are focused on treating their disease without compromising the way they live. They want to be able to manage their cancer in a way that doesn't limit their daily activities."

Phase III Summary

More than 900 patients with advanced renal cell carcinoma, who had previously failed one prior systemic therapy, were randomized one-to-one to receive either 400 mg of sorafenib or placebo twice a day. The primary endpoint of the study is overall survival, with progression-free survival, overall response rate, quality of life, and safety also being assessed.

In April 2005, the companies unblinded the trial and announced that patients enrolled in the phase III kidney cancer trial who were receiving placebo could cross over to drug treatment based on the clinical and statistical significance of the definitive analysis of progression-free survival data. Overall survival results presented at ASCO 2006 were based on an analysis of 367 survival events (patient deaths) that had occurred by November 30, 2005.