Updated Overall Survival Analysis Presented on Nexavar Phase III Trial
06 June 2006 - 1:00AM
PR Newswire (US)
Abstract # 4524 ATLANTA, June 5 /PRNewswire-FirstCall/ -- Bayer
Pharmaceuticals Corporation (NYSE:BAY) and Onyx Pharmaceuticals,
Inc. (NASDAQ:ONXX) today reported that Dr. Tim Eisen provided an
update on the Nexavar(R) (sorafenib) tablets Phase III trial in
patients with advanced renal cell carcinoma (RCC), or kidney
cancer, during the 42nd Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Atlanta, GA. Dr. Eisen is the
consultant medical oncologist at The Royal Marsden Hospital in
London, United Kingdom. The updated analysis confirmed that overall
survival was longer for Nexavar than for placebo patients. The
updated data showed a continued improvement in overall survival
(OS) of 19.3 months for Nexavar patients versus 15.9 months for
placebo patients (p=0.015, hazard ratio 0.77) despite the fact that
48% of placebo patients "crossed over" to Nexavar. Dr. Eisen also
reported OS of 19.3 months for Nexavar vs.14.3 months for placebo
(p=0.010, hazard ratio 0.74) after censoring the placebo patients.
These data, while they did not reach the pre- specified result
required to stop the OS analysis early, suggest a favorable
survival trend for patients who received Nexavar. In April 2005,
the trial was unblinded and patients who were receiving placebo
could "cross over" to treatment with Nexavar based on the clinical
and statistical significance of a definitive analysis of
progression free survival. The final analysis of OS is planned when
540 events are observed. "Consistent with the original interim
analysis, patients receiving Nexavar lived longer than patients
receiving placebo, despite almost 50% of placebo patients crossing
over to Nexavar," said Dr. Eisen. "These data are encouraging and
should be considered preliminary pending the final analysis," said
Dr. Eisen. Quality of Life (QOL) Data (Abstract #4534) An
evaluation of health-related quality of life and symptoms of the
Phase III patient population was also presented today. In the
study, Nexavar demonstrated a clinical benefit (as evidenced by
Progression Free Survival) without adversely impacting overall
quality of life, and had a positive impact on individual symptoms,
such as cough, fevers, "shortness of breath", "worry that condition
will worsen" and "ability to enjoy life." "Quality of life is such
an important issue for kidney cancer patients as many of them do
not have evident disease symptoms," said Bill Bro, president of the
Kidney Cancer Association. "Today, patients are focused on treating
their disease without compromising the way they live. They want to
be able to manage their cancer in a way that doesn't limit their
daily activities." Phase III Summary More than 900 patients with
advanced RCC, who had previously failed one prior systemic therapy,
were randomized one-to-one to receive either 400 mg Nexavar or
placebo twice a day. The primary endpoint of the study is overall
survival, with progression-free survival (PFS), overall response
rate, quality of life, and safety also being assessed. PFS measures
the length of time that a patient lives without evident tumor
growth or death. In April 2005, the companies unblinded the trial
and announced that patients enrolled in the Phase III kidney cancer
trial who were receiving placebo could "cross over" to drug
treatment based on the clinical and statistical significance of the
definitive analysis of PFS data. Overall survival results presented
at ASCO 2006 were based on an analysis of 367 survival events
(patient deaths) that had occurred by November 30, 2005. About
Nexavar Nexavar is an oral multi-kinase inhibitor that targets both
the tumor cell and tumor vasculature. In preclinical models,
Nexavar targeted 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-2, VEGFR-3,
PDGFR-B, KIT, and FLT-3. Nexavar has been studied in more than 20
tumor types and in more than 8,000 clinical trial patients. It has
demonstrated combinability with multiple anticancer agents, and is
currently in Phase III clinical trials for the treatment of
advanced hepatocellular carcinoma (HCC), or liver cancer, and
metastatic melanoma, or skin cancer. A Phase III clinical trial in
non-small cell lung cancer (NSCLC) was initiated in February 2006.
In addition to company-sponsored trials, there are a variety of
Nexavar studies being sponsored by government agencies, cooperative
groups and individual investigators. About Kidney Cancer Renal cell
carcinoma is the most common form of kidney cancer. Nearly 208,000
people worldwide are diagnosed (about 37,000 Americans) with renal
cell carcinoma each year and more than 102,000 of them die (about
12,000 Americans) from the disease annually. For more information
on renal cell carcinoma, visit the Kidney Cancer Association (KCA)
web site at: http://www.curekidneycancer.org/. Important Safety
Considerations for U.S. Patients Taking Nexavar Based on the
currently approved package insert for the treatment of patients
with advanced kidney cancer, hypertension may occur early in the
course of therapy and blood pressure should be monitored weekly
during the first six weeks of therapy and treated as needed.
Incidence of bleeding regardless of causality was 15% for Nexavar
vs. 8% for placebo and the incidence of treatment-emergent cardiac
ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most
common treatment-emergent adverse events with Nexavar were
diarrhea, rash/desquamation, fatigue, hand-foot skin reaction,
alopecia, and nausea. Grade 3/4 adverse events were 38% for Nexavar
vs. 28% for placebo. Women of child-bearing potential should be
advised to avoid becoming pregnant and advised against
breast-feeding. In cases of any severe or persistent side effects,
temporary treatment interruption, dose modification or permanent
discontinuation should be considered. For U.S. Nexavar prescribing
information, visit http://www.nexavar.com/ or call 1.866.NEXAVAR
(1.866.639.2827). 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 Nexavar with Bayer Pharmaceuticals Corporation. For more
information about Onyx's pipeline and activities, visit the
company's web site at: http://www.onyx-pharm.com/. About Bayer
Pharmaceuticals Corporation Bayer Pharmaceuticals Corporation
(http://www.bayerpharma.com/) is part of the worldwide operations
of Bayer HealthCare AG, a subsidiary of Bayer AG. Bayer HealthCare
AG, with sales of approximately 9.4 billion Euros in 2005, is one
of the world's leading, innovative companies in the healthcare and
medical products industry. The company combines the global
activities of the Animal Health, Consumer Care, Diabetes Care,
Diagnostics and Pharmaceuticals divisions. Bayer Pharmaceuticals
Corporation is part of the new Global Pharmaceutical Division,
established January 1, 2006, which consists of the former
Biological Products and Pharmaceutical Division and now comprises
three business units: Hematology/Cardiology; Oncology and Primary
Care. Bayer HealthCare AG employed 33,800 people worldwide in 2005.
Bayer HealthCare AG's aim is to discover and manufacture innovative
products that will improve human and animal health worldwide. The
products enhance well-being and quality of life by diagnosing,
preventing and treating disease. Forward Looking Statements This
news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various
known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results,
financial situation, development or performance of the company and
the estimates given here. These factors include those discussed in
Bayer's public reports filed with the Frankfurt Stock Exchange and
with the U.S. Securities and Exchange Commission (including its
Form 20-F). Bayer assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or
developments. This news release also contains "forward-looking
statements" of Onyx within the meaning of the federal securities
laws. These forward-looking statements include without limitation,
statements regarding the timing, progress and results of the
clinical development, regulatory processes, and commercialization
efforts of Nexavar. These statements are subject to risks and
uncertainties that could cause actual results and events to differ
materially from those anticipated. Reference should be made to
Onyx's Annual Report on Form 10-K for the year ended December 31,
2005, filed with the Securities and Exchange Commission under the
heading " Risk Factors" and Onyx's Quarterly Reports on Form 10-Q
for a more detailed description of such factors. Readers are
cautioned not to place undue reliance on these forward- looking
statements that speak only as of the date of this release. Onyx
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances
after the date of this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer
Pharmaceuticals Corporation. DATASOURCE: Bayer Pharmaceuticals
Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett,
Bayer HealthCare, +1-203-812-2160; Julie Wood, Onyx
Pharmaceuticals, Inc., +1-510-597-6505; Dr. Michael Diehl, Bayer
HealthCare, +49-214-30-58532; Geoff Curtis, GCI Group,
+1-312-229-8702, +1- 312-550-8138 (on site at ASCO) Web site:
http://www.bayerpharma.com/ http://www.onyx-pharm.com/
http://www.nexavar.com/ http://www.curekidneycancer.org/
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