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Preliminary results require further analysis and interpretation
Berlin, September 30, 2009 - Bayer HealthCare AG and Onyx Pharmaceuticals, Inc.
today announced results from a randomized, placebo-controlled Phase II trial
sponsored by Northwestern University. The study, which evaluated Nexavar®
(sorafenib) tablets in combination with the chemotherapeutic agent paclitaxel
in patients with locally advanced or metastatic HER-2 negative breast cancer,
demonstrated a positive trend towards improvement of progression-free survival
in the treatment group (p-value=0.09).The safety and tolerability profile of
the combination was consistent with previous experience with each agent and no
new toxicities were observed. A complete data analysis from this study is
expected to be presented at an upcoming scientific meeting. Patients are
continuing to be followed for a secondary endpoint of overall survival.
The trial was led by principle investigator William Gradishar, M.D., professor
of medicine, Robert H. Lurie Comprehensive Cancer Center of Northwestern
University. "These encouraging data warrant further investigation to determine
the potential of the Nexavar and paclitaxel treatment combination in patients
with advanced breast cancer, an often underserved patient population," said Dr.
Gradishar.
"The preliminary results in this study demonstrate a clinical signal in favor
of this treatment combination. These data require further analysis and
interpretation before we determine the appropriate path forward," said Dimitris
Voliotis, vice president, Global Clinical Development Oncology, Bayer
HealthCare. "This trial is the second of four from our comprehensive clinical
program in breast cancer, which is intended to explore Nexavar's utility in a
number of disease settings."
Bayer and Onyx recently reported statistically significant results in a
randomized Phase II trial demonstrating that Nexavar in combination with the
oral chemotherapeutic agent, capecitabine, significantly extended progression
free survival by 74% in patients with locally advanced or metastatic HER-2
negative breast cancer. Treatment with Nexavar plus capecitabine was tolerable
and resulted in no new side effects. Common grade 3 or 4 treatment-related
adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia
and mucositis.
Breast Cancer Trial Design and Results
The randomized, double-blind, placebo-controlled Phase II study evaluated
Nexavar in combination with the chemotherapeutic agent, paclitaxel, in 237
patients. These patients had locally recurrent or metastatic HER-2 negative
breast cancer and had not received prior chemotherapy in this setting. The
study included an assessment of the primary endpoint of 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 paclitaxel, given at 90 mg/m2
weekly for three weeks followed by one week of rest.
About the Nexavar Clinical Program in Breast Cancer
The study is part of a clinical development program known as TIES (Trials to
Investigate the Effects of Sorafenib in Breast Cancer), where Nexavar is being
evaluated in collaboration with investigators and cooperative groups in four
large randomized Phase II trials for patients with advanced breast cancer and
in a variety of treatment settings. In addition to the study evaluating Nexavar
in combination with paclitaxel, Bayer and Onyx recently reported results in a
Phase II trial demonstrating that Nexavar in combination with the oral
chemotherapeutic agent, capecitabine, significantly extended progression free
survival. One of two remaining trials is evaluating Nexavar plus gemcitabine or
capecitabine in the first- or second-line setting following progression on
bevacizumab, and the second trial is evaluating 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 leading cause of death
among women with cancer (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). Approximately, 75% of women diagnosed have HER-2 negative
breast cancer and 25% have HER-2 positive breast cancer. There are
approximately 200,000 new cases of breast cancer in the U.S. and 430,000 in
Europe each year. More than 40,000 women in the U.S. 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 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.
