Recently Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. provided the results of their collaborative double-blind placebo controlled Phase II clinical trials regarding the combination of Nexavar with capecitabine in the treatment of breast cancer. The study showed that the combo stopped the progression of the disease in patients with advanced breast cancer.
The findings were delivered in a presentation at the 15th European CanCer Organization (ECCO). This was in conjunction with the 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin, Germany. This was the first group effort between the two companies. Bayer HealthCare, which is located in Leverkusen, is a subsidiary of Bayer AG and is one of the world’s leading and innovative companies in the medical and healthcare industry. Onyx Pharmaceuticals, Inc. is a biopharmaceutical company that is dedicated to cancer research and improving the lives of people who are suffering from cancer.
The principal investigator of this study, Joes Baselga, M.D. is the chairman and Professor of Medicine at Vall d’Hebron Institute of Oncology in Barcelona. He is also the scientific chairman of SOLTI, the Spanish Collaborative Group for the Study, Treatment and Other Experimental Strategies in Solid Tumors. Founded in 1995, SOLTI works with industry experts to provide cutting edge clinical research to reduce the death rate in breast cancer, provide clinical trials and work hand in hand with targeted therapeutic programs in oncology. Their network of oncology specialists covers Spain and Portugal.
The results of the clinical study show that the use of Nexavar in combination with the oral chemotherapeutic capecitabine showed a 74 percent improvement in the length of time the clinical trial patients lived with breast cancer without their disease progressing. Furthermore, there were no additional side effects from the use of the combined medications.
Nexavar is already used in Europe to treat liver and kidney cancer. It is an oral anti cancer treatment that is approved for use in over 80 countries for liver cancer and more than 90 countries as a treatment for people with advanced kidney cancer. It is also being evaluated as a single treatment or as a combination with another medication in patients with other types of cancer including ovarian, lung and colorectal.
Breast cancer was diagnosed in more than 1.3 million women from 2007-2008 and was the most commonly diagnosed cancer among women. It is the second highest cause of cancer related deaths among women. It results in the death of more than 40,000 women in the United States and 130,000 women in Europe every year.
The program which is called the Trials to Investigate Effects of Sorafenib in Breast Cancer or (TIES) Nexavar is being tested as to its effectiveness with investigators and through collaborative efforts. There are three ongoing Phase II clinical trials that are underway. The first one is Nexavar with paclitaxel, Nexavar with gemcitabine or capecitabine and Nexavar with docetaxek and/or letrozole all in first or second line settings. The current clinical trial followed 229 patients with advanced or metastatic HER-2 negative breast cancer. The main focus of the test was to keep the patient’s cancer from progressing, with secondary focus on survival and safety.
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