Bayer, Onyx Halt Nexavar Phase III Trial in Lung Cancer Patients
By Anna Boyd
10:13, February 19th 2008
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Bayer, Onyx Halt Nexavar Phase III Trial in Lung Cancer Patients

Bayer Health Care Pharmaceutical and Onyx Pharmaceuticals Inc said Monday they had stopped a phase III trial of Nexavar in patients with non-small cell lung cancer, because the product failed to help patients live longer than standard treatment.

Bayer and Onyx are co-developers of Nexavar, also known as sorafenib, which is already approved in the United States and Europe for the treatment of liver cancer and kidney cancer. The drug is also being studied as a treatment for other cancers, including metastatic melanoma, breast cancer.

In the late-stage study, patients received Nexavar in combination with chemotherapeutic drugs carboplatin and paclitaxel. The companies said that higher mortality was observed in a certain subset of patients treated with the combination of Nexavar and the chemotherapeutic drugs, versus those treated with carboplatin and paclitaxel alone.

That’s why the a panel of independent experts monitoring the safety of the tests concluded that the study was unlikely to meet its primary goal of showing that Nevaxar improves overall survival, the companies said in a joint statement, according to Reuters.

Nevaxar is one of Bayer’s most promising new drugs. The company has previously said it expects it to generate combined annual sales of up to 2 billion Euros, 750 million Euros of which from non-small cell lung cancer.

Bayer had hoped to launch Nexavar for non-small cell lung cancer in 2009.

Bayer shares closed down 2.3 percent at 54.15 euros. Shares of Onyx closed down 1.1 percent at $44.98 on Friday. U.S. stock markets were closed on Monday.



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