Phase III trial findings presented at cancer congress (ASCO) in United
States
Kidney cancer drug sorafenib doubles progression-free survival rate
Product could be launched in the first half of 2006
Leverkusen - Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today
announced that sorafenib (formerly BAY 43-9006) was shown to significantly
slow tumor progression in an ongoing Phase III trial in patients with
advanced renal cell carcinoma (RCC), or kidney cancer. Results from the
international study -- the largest randomized, controlled study in advanced
kidney cancer -- were presented at the meeting of the American Society of
Clinical Oncology (ASCO) in Orlando, Florida by Dr. Bernard Escudier, one
of the principal investigators, from the Gustave-Roussy Institute, Paris,
France. In the study, as assessed by independent radiological review, the
median progession-free survival rate in the sorafenib group was 24 weeks
(167 days) compared with 12 weeks (84 days) for patients receiving placebo.
"We are encouraged by the Phase III clinical results with sorafenib and
look forward to further studies in other tumors and in combination with
other agents," said Arthur Higgins, chairman of Bayer HealthCare's
executive committee. "We are working diligently to complete our NDA filing
and hope to launch sorafenib in the first half of 2006 if approved by the
FDA."
Discussions are also underway with regulatory agencies about registration
in other territories.
More than 900 patients with advanced kidney cancer, who had previously
failed one prior systemic therapy, have been randomized in the ongoing
multi-national, placebo-controlled Phase III study. 120 sites are
participating in the trial. Participating patients were randomized to
either 400 mg sorafenib or placebo twice daily. On April 18 -- following
further review of the data and discussions with the principal
investigators, an independent data monitoring committee (DMC), and with
regulatory authorities -- the companies announced that all patients in the
ongoing Phase III trial should be offered access to sorafenib. The study
started in the fourth quarter of 2003. The primary end point of the study
is overall survival.
In the study drug-related adverse events (all grades) were similar to what
has been observed in previous clinical trials and included rash, diarrhea,
hand foot syndrome, hair loss, itching and nausea, and hypertension. There
was no difference in fatigue when comparing the sorafenib-treated patients
to those patients receiving placebo.
About sorafenib
Sorafenib, a novel investigational drug candidate, has demonstrated both
anti-proliferative and anti-angiogenic properties - two important
anticancer activities. Preclinical studies have shown that sorafenib
inhibits the enzyme RAF kinase, thus blocking an important chemical
signaling cascade which regulates cell division and therefore cellular
growth. Sorafenib also inhibits the formation of new blood vessels, thus
suppressing the supply of nutrients to tumors.
About Bayer HealthCare AG
Bayer HealthCare AG, a subgroup of Bayer AG with sales of approximately
€8.5 billion in 2004, is one of the world's leading, innovative companies
in the health care and medical products industry.
The company combines the global activities of the Animal Health, Biological
Products, Consumer Care, Diagnostics, Diabetes Care and Pharmaceuticals
divisions. 35,300 people were employed by Bayer HealthCare worldwide in
2004.
Bayer HealthCare’s aim is to discover and manufacture innovative products
that will improve human and animal health worldwide. Our products enhance
well-being and quality of life by diagnosing, preventing and treating
disease.
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer
therapies that target the molecular basis of cancer. With its
collaborators, the company is developing small-molecule drugs, including
sorafenib with Bayer Pharmaceuticals Corporation. For more information
about Onyx’s pipeline and activities, visit the company’s web site at:
www.onyx-pharm.com.
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