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Bayer says Nexavar improved survival in Phase III cancer study UPDATE


Published :
Mon, 27 Aug 2007 06:55
By : Agencies
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(updating to add details on study, HCC)

BERLIN (Thomson Financial) - Bayer AG and Onyx Pharmaceuticals Inc said an independent data monitoring committee found that cancer drug Nexavar 'significantly' improved overall survival of patients with advanced hepatocellular carcinoma (HCC), the most common form of liver cancer, in a Phase III trial in the Asia-Pacific region.

Based on the committee's recommendation, the trial will be stopped to allow all patients to receive treatment with Nexavar, Bayer said in a statement.

Data from this study will be submitted for presentation at an upcoming scientific meeting, it said, without being more specific.

The randomised, double-blind study, which was conducted at the request of Asian health authorities to provide supplemental information on Nexavar's efficacy and safety in Asian-Pacific patient populations, comprised some 226 patients in China, Korea and Taiwan.

Bayer has completed regulatory filings for Nexavar to treat liver cancer in several countries in Europe as well as in China and the US, and additional submissions are currently being finalized, Bayer said.

HCC accounts for about 90 pct of primary malignant liver tumours in adults, making it the sixth most common cancer in the world and the third leading cause of cancer-related deaths globally.

Risk factors for liver cancer include ongoing infection with the hepatitis B virus and the hepatitis C virus.

maria.sheahan@thomson.com

mas/ejp/mas/ejp

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