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Phase II Study in Advanced Breast Cancer:
First presentation of results at joint ECCO-ESMO congress in Berlin, Germany
Abstract # 3LBA
Berlin, September 23, 2009 - Bayer HealthCare AG and Onyx Pharmaceuticals, Inc.
today announced the full results from their first collaborative group-sponsored
randomized, double-blind, placebo controlled Phase II trial showing that
Nexavar® (sorafenib tablets) in combination with the oral chemotherapeutic
agent, capecitabine, significantly extended progression-free survival in
patients with advanced breast cancer by 74 percent. The data were presented at
the joint 15th European CanCer Organisation (ECCO) and 34th European Society
for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin, Germany.
Jose Baselga, M.D., chairman and Professor of Medicine at Vall d'Hebron
Institute of Oncology in Barcelona, scientific chairman of SOLTI and the
principal investigator of this study, reported that patients receiving Nexavar
plus capecitabine had a 74 percent improvement in the time they lived without
their disease progressing compared to those who received chemotherapy alone.
The difference in median progression-free survival of Nexavar plus capecitabine
versus capecitabine plus placebo was statistically significant, 6.4 months vs.
to 4.1 months (HR=0.576, p=0.0006).
"These data represent a potentially significant advance in the treatment of
breast cancer, which is the second leading cause of cancer-related death in
women," said Dimitris Voliotis, vice president, Global Clinical Development
Oncology, Bayer HealthCare. "In addition to the positive signal generated in
this trial, Bayer and Onyx are committed to the development of Nexavar in
breast cancer in a variety of settings through a robust clinical program."
The study evaluated Nexavar in combination with the oral chemotherapeutic,
capecitabine, in patients with locally advanced or metastatic HER-2 negative
breast cancer. Overall, treatment with Nexavar plus capecitabine showed an
acceptable tolerability, without any new side effects. Common grade 3 or 4
treatment-related adverse events included hand-foot skin reaction, diarrhea,
dyspnea, neutropenia and mucositis.
Breast Cancer Phase-II-Trial Design
The randomized, double-blind, placebo-controlled Phase II study evaluated
Nexavar in combination with the oral chemotherapeutic agent, capecitabine, in
229 patients. All patients had locally advanced or metastatic HER-2 negative
breast cancer and had received no more than one prior chemotherapy. The primary
endpoint of the study was progression-free survival. Secondary endpoints
included overall survival, time to progression, and safety. Patients were
randomized to receive 400 mg of oral Nexavar or matching placebo twice daily,
in addition to 1000 mg/m2 of capecitabine twice daily for 14 days followed by a
seven day rest from capecitabine.
"Bayer and Onyx have built a strong foundation with Nexavar in treating
unresectable liver cancer and advanced kidney cancer - both disease areas with
a previously unmet treatment need," said Todd Yancey, M.D., vice president of
clinical development at Onyx. "These new results signify an important step in
understanding the potential role of Nexavar in breast cancer."
About the Nexavar Clinical Program in Breast Cancer
In a clinical development program known as Trials to Investigate the Effects of
Sorafenib in Breast Cancer (TIES), Nexavar is being evaluated in diverse
treatment settings for patients with breast cancer in collaboration with
investigators and cooperative groups. Among these clinical trials are three
ongoing randomized Phase II studies, including a trial to evaluate Nexavar plus
paclitaxel in the first-line setting, a trial to evaluate Nexavar plus
gemcitabine or capecitabine in the first- or second-line setting following
progression on bevacizumab, and a trial to evaluate Nexavar plus docetaxel
and/or letrozole in the first-line setting.
About Breast Cancer
Breast cancer was the most commonly diagnosed cancer among women worldwide in
2007-2008 (approximately 1.3 million cases), and the second leading cause of
cancer-related death among women (approximately 465,000 deaths). It is the most
commonly diagnosed cancer among women in the United States (1 in 4 cancer
diagnoses is breast cancer). There are approximately 200,000 new cases of
breast cancer in the United States and 430,000 in Europe each year. More than
40,000 women in the United States and more than 130,000 in Europe die of breast
cancer each year.
About Nexavar®
Nexavar®, an oral anti-cancer therapy, is currently approved in more than 80
countries for liver cancer and in more than 90 countries for the treatment of
patients with advanced kidney cancer. In Europe, Nexavar is approved for the
treatment of hepatocellular carcinoma and for the treatment of patients with
advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or
interleukin-2 based therapy or are considered unsuitable for such therapy.
Nexavar targets both the tumor cell and tumor vasculature. In preclinical
studies, Nexavar has been shown to target members of two classes of kinases
known to be involved in both cell proliferation (growth) and angiogenesis
(blood supply) - two important processes that enable cancer growth. These
kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR B, KIT, FLT-3 and
RET.
Nexavar is also being evaluated by the companies, international study groups,
government agencies and individual investigators as a single agent or
combination treatment in a wide range of cancers, including lung, ovarian and
colorectal cancer and as an adjuvant therapy for liver and kidney cancer.
About SOLTI
Founded in 1995, SOLTI (Spanish Collaborative Group for the Study, Treatment
and Other Experimental Strategies in Solid Tumors) is a collaborative group
that leads cutting-edge clinical research in breast cancer to answer important
questions that will lead to a reduction in the morbidity and mortality in
breast cancer, and to carry out trials with new molecules and targeted
therapeutics in oncology. SOLTI's network of high level oncology services spans
Spain and Portugal promoting excellence in breast cancer care.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is a biopharmaceutical company committed to
improving the lives of people with cancer. The company, in collaboration with
Bayer HealthCare Pharmaceuticals, Inc., is developing and marketing Nexavar®
(sorafenib) tablets, a small molecule drug. For more information about Onyx,
visit the company's website at www.onyx-pharm.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
Details on the study and the abstract # 3LBA can be found on the ECCO 15 - 34th
ESMO website:
http://www.ecco-org.eu/Conferences-and-Events/ECCO-15/page.aspx/216
