Trial patients offered active drug

Bayer Pharmaceuticals and Onyx Pharmaceuticals have recommended that all patients in their ongoing Phase III trial in advanced renal cell carcinoma (RCC) be offered access to sorafenib (formerly BAY 43-9006), a novel investigational drug candidate that has demonstrated both anti-proliferative and anti-angiogenic properties - two important anticancer activities.

The decision follows further review of data from a recent planned analysis of progression-free survival, as well as additional discussions with the principal investigators, an independent data monitoring committee (DMC), and with regulatory authorities. Interim data from the Phase III study will be presented at the American Society of Clinical Oncology meeting, 13- 17 May, Orlando, Florida.

The companies are communicating this information to the study investigators, and it is expected that investigators will begin reaching out to participating patients. In addition, Bayer and Onyx will continue preparing a new drug application for possible approval in the US. The companies will also continue discussions with regulators outside the US about proceeding with a filing based on the results of this trial as amended.

The multi-national, placebo-controlled Phase III study recently finished enrolling over 800 patients with advanced kidney cancer. The primary endpoint of the study is overall survival, with progression-free survival, overall response rate, and safety also being assessed.

'Interim data from the Phase III trial showed that patients taking sorafenib had a clinically significant improvement in the duration of disease stabilization (defined as progression-free survival). Based on this, Bayer and Onyx agreed that it was in the best interest of patients to offer sorafenib to all study participants,' said Wolfgang Plischke, president of Bayer HealthCare's global pharmaceutical division.

Sorafenib previously received Orphan Drug designation for RCC from both the US FDA and the European Medicines Agency (EMEA).