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Berlin, October 23, 2009 - Bayer HealthCare AG and Onyx Pharmaceuticals, Inc.
today announced that the companies have begun enrolling patients in an
international Phase III trial to evaluate Nexavar® (sorafenib) tablets for the
treatment of patients with radioactive iodine-refractory, locally advanced or
metastatic differentiated thyroid cancer. This Phase III trial was started
based on the results from Phase II clinical trials evaluating Nexavar in
patients with advanced thyroid cancer.
"Patients with thyroid cancer, particularly those who failed to respond to
surgical or radiotherapies have limited treatment options to help them manage
their disease," said Dimitris Voliotis, Vice President, Clinical Development,
Bayer HealthCare. "Recognizing this unmet need, we are evaluating Nexavar in
this special patient population."
Phase III Trial Design
The DECISION (stuDy of sorafEnib in loCally advanced or metastatIc patientS
with radioactive Iodine-refractory thyrOid caNcer) trial is an international,
multicenter, randomized, placebo-controlled study that will enroll
approximately 400 patients with locally advanced or metastatic, radioactive
iodine-refractory, differentiated thyroid cancer (papillary, follicular and
Hurthle cell) who have received no prior systemic therapy.
Patients will be randomized to receive 400 mg of oral Nexavar twice daily or
matching placebo. Patients will continue on treatment until disease
progression, toxicity, non-compliance or withdrawal of consent. At the time of
progression, patients receiving placebo will have an option to cross over to
Nexavar at the discretion of the investigator, based on the patient's clinical
status. The primary endpoint of the study is progression-free survival as
defined by RECIST criteria. Secondary endpoints include overall survival, time
to progression and response rate. The safety and tolerability of the two
treatment groups will also be compared.
The study will be conducted at sites in the United States, Europe, Asia, and
Japan. For information about enrolling in the study, please visit
www.clinicaltrials.gov.
Phase II Trial Results
Updated results from a single-institution, investigator-sponsored Phase II
open-label study in 55 patients with metastatic, iodine-refractory, thyroid
cancer treated with Nexavar 400 mg were presented at the American Society of
Clinical Oncology (ASCO) Annual Meeting, May 29-June 3, Orlando, FL, by Marcia
Brose, M.D., Ph.D., an assistant professor of Hematology/Oncology and
Otorhinolaryngology in the Abramson Cancer Center of the University of
Pennsylvania, Philadelphia, PA, U.S.A. In 50 evaluable patients, 18 (36
percent) had a partial response per RECIST criteria. Updated survival results
on the first 30 patients enrolled into the study demonstrated that across all
histologies the median progression-free survival (PFS) was 63 weeks and the
median overall survival was 140 weeks. The most common adverse events (AE) seen
in the trial were palmar-plantar erythema, rash, fatigue, stomatitis/mucositis,
weight loss, and musculoskeletal pain, and were predominantly grade 1 or 2. Dr.
Brose and Martin J. Schlumberger, Institut Gustave-Roussy, Villejuif, France
are the lead investigators on the Phase III trial.
"Based on the positive signal generated in the Phase II trial, the initiation
of this Phase III trial represents progress in exploring the full potential of
Nexavar in a variety of treatment settings and tumor types," said Todd Yancey,
Vice President of clinical development at Onyx. "Building on our successful
foundation of treating unresectable liver cancer and kidney cancer, we are
hopeful that this Phase III trial will lead to a new treatment option for
patients with non-responsive thyroid cancer."
About Thyroid Cancer
Thyroid cancer, one of the few cancers that has increased in incidence over the
past several years, is the sixth most common cancer in women and about three
times as many women as men get thyroid cancer. There are more than 140,000 new
cases of thyroid cancer and more than 35,000 people die worldwide 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 breast, 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.
