BAY 43-9006 Delays Disease Progression in Study of Advanced Kidney Cancer

An independent data monitoring committee has reviewed the safety and efficacy data from Bayer Pharmaceuticals' and Onyx Pharmaceuticals' pivotal Phase III trial in patients with advanced kidney cancer and has concluded that the trial met its surrogate endpoint -- resulting in statistically significant longer progression-free survival in those patients administered BAY 43-9006 versus those patients administered placebo.

As a result of this favorable outcome, Bayer and Onyx plan to prepare a new drug application for possible accelerated approval in the U.S. As previously agreed with the FDA, the two companies will continue the Phase III study as originally planned to its primary endpoint of overall survival.

The multinational, placebo-controlled, Phase III study recently finished enrolling more than 800 patients with advanced kidney cancer. The primary endpoint of the study is overall survival, with disease progression, overall response rate and safety also being assessed. The pivotal trial was initiated in the fourth quarter of 2003 after a special protocol assessment was completed by the FDA.