Bayer And Onyx Say Nexavar Fails To Meet Primary Endpoint In Liver Cancer Trial

(RTTNews) - Bayer HealthCare Pharmaceuticals Inc., a subgroup of Bayer AG (BAYZF.PK, BAYRY.PK, BYR.L), and Onyx Pharmaceuticals Inc., an subsidiary of Amgen (AMGN), announced that a Phase III trial evaluating sorafenib (Nexavar) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC, a form of liver cancer) who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival.

The safety findings were consistent with the known profile of sorafenib. Data from this study will be submitted for presentation at an upcoming scientific congress.

"We are disappointed that the trial did not meet its primary endpoint. However, we remain committed to exploring the full potential of sorafenib in all stages of liver cancer," said Jörg Möller, member of the Bayer HealthCare Executive Committee and Head of Global Development.

Bayer stated that the outcome announced today does not affect the currently approved indications. Nexavar remains the only approved systemic treatment for unresectable HCC with a proven overall survival benefit.

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for approximately 70-85 percent of the total liver cancer burden worldwide.

Nexavar (sorafenib), an oral anti-cancer therapy, is currently approved in more than 100 countries worldwide. In Europe, it is approved for the treatment of hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

Nexavar is also approved in the United States for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment.

Nexavar is co-developed by Onyx Pharmaceuticals, Inc. and Bayer, except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S. Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.