From: Reuters
Published February 18, 2008 01:43 PM

Bayer stops late-stage Nexavar trial

FRANKFURT (Reuters) - Bayer HealthCare, a U.S.-based unit of Bayer AG <BAYG.DE>, said on Monday it had stopped a late-stage trial of Nexavar in patients with non-small cell lung cancer, after an independent data monitoring committee said it would not meet the main goal of improved overall survival.

In the late-stage study, patients received Nexavar in combination with chemotherapeutic drugs carboplatin and paclitaxel.

Bayer said 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.

Bayer had expected annual peak sales of around 750 million euros ($1.1 billion) from Nexavar in this indication. Bayer had hoped to launch Nexavar for non-small cell lung cancer in 2009.


Bayer and co-developer Onyx Pharmaceuticals Inc <ONXX.O> will review the findings of the analysis to determine what, if any, impact they have on other ongoing Nexavar lung cancer trials.

Nexavar, also known as sorafenib, is approved in the United States and Europe for kidney cancer and liver cancer. The companies are studying the drug for treatment of a broad range of cancers, including breast cancer.

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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