Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc. has announced that a phase III trial administering Nexavar (sorafenib) or placebo tablets in combination with the chemotherapeutic agents carboplatin and paclitaxel in patients with advanced melanoma did not meet its primary endpoint of improving progression-free survival (PFS).

The treatment effect was comparable in each arm. Data from the study will be presented at an upcoming scientific congress.

"We are disappointed, first and foremost, for the patients with refractory metastatic melanoma for which treatment options are so limited," said Hollings C Renton, Onyx's chairman, president, and chief executive officer. "However, this trial does not change our commitment to, and belief in, Nexavar. We hope to demonstrate utility in a wide variety of tumours and we will continue to broaden our clinical programme, including increasing our attention to the more common malignancies in which anti-angiogenics have demonstrated activity."

The international phase III, double-blind, randomized, placebo-controlled trial evaluated Nexavar when administered in combination with a standard dosing schedule (21-day cycles) of carboplatin and paclitaxel. Two hundred seventy patients progressing after one previous systemic chemotherapeutic treatment (with either dacarbazine (DTIC) or temozolomide) were enrolled into the study.

Nexavar is an oral multi-kinase inhibitor that targets both the tumour cell and tumour vasculature. In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both cell proliferation (growth) and angiogenesis (blood supply) -- two important processes that enable cancer growth. These kinases included RAF kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-?, KIT, and FLT-3.Nexavar is currently approved in a number of countries, including the U S and the EU, for the treatment of patients with advanced kidney cancer. In addition, Nexavar is being evaluated as a single agent in a Phase III clinical trial for the treatment of advanced hepatocellular carcinoma (HCC), or liver cancer, a study that has completed enrolment. A Phase III clinical trial of Nexavar combined with carboplatin and paclitaxel in non-small cell lung cancer (NSCLC) for treatment-naive patients was initiated in the first half of 2006.