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Trial Shows Drug Not Extending Breast Cancer Survival Time

Breast self-exam

(National Cancer Institute)

25 July 2014. A late-stage clinical trial of the cancer drug sorafenib shows the drug, combined with the chemotherapy drug capecitabine, does not extend the amount of progression-free survival time of advanced breast cancer patients, compared to capecitabine alone. Sorafenib, marketed under the brand name Nexavar, is made by Onyx Pharmaceuticals in South San Francisco, California, a subsidiary of the pharmaceutical company Amgen, and Bayer HealthCare, based in Berlin.

Sorafenib is an oral cancer therapy already approved by regulatory authorities in the U.S. and Europe for advanced or inoperable liver and kidney cancer, as well as in the U.S. for progressing thyroid cancer that cannot be treated with radioactive iodine. In preclinical studies, sorafenib inhibites the actions of multiple enzymes involved with cell proliferation and tumor blood supply that encourage cancer growth. As a result, the companies are testing sorafenib as a treatment for other cancer types.

The clinical trial recruited 537 women in 20 countries including the U.S., Japan, and Australia, as well as in Europe. Patients in the trial had locally advanced or metastatic (spreading) breast cancer where human epidermal growth factor receptor 2 or HER2 proteins are not overexpressing, a condition known as HER2-negative breast cancer. HER2-positive breast cancer tends to grow faster and is more likely to spread than HER2-negative.

The trial tested sorafenib in combination with the chemotherapy drug capecitabine, marketed by Genentech under the brand name Xeloda. Capecitabine is approved alone to treat colorectal cancer as well as breast cancer in combination with other drugs. Patients were randomly assigned to receive either sorafenib combined with capecitabine, or a placebo combined with capecitabine. Sorafenib or the placebo was taken every day for 21 days, with capecitabine taken by all patients for the first 14 days.

The primary measure of the drugs’ efficacy was progression-free survival, the amount of time during or after treatment that a patient lives with the disease but does not get worse. The companies did not release details of the results, but in a joint statement, Joerg Moeller, Bayer HealthCare’s global development director says “the trial did not show an improvement in progression-free survival in patients with advanced breast cancer.” Onyx and Bayer HealthCare say they plan to discuss detailed results from the trial at an upcoming scientific meeting.

Sorafenib is being developed by Onyx and Bayer HealthCare under an agreement where each company funds development costs for the drug, except in Japan, where Bayer funds all product development. The two companies co-promote sorafenib in the U.S. and divide equally any profits or losses. Outside the U.S., Bayer has exclusive marketing rights, but Onyx and Bayer share profits equally. The exception is Japan, for which Bayer in 2011 paid Onyx a one-time fee of $160 million as part of their collaboration.

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