Bayer and Onyx Announce Pivotal Nexavar(R) Kidney Cancer Study Published in New England Journal of Medicine
11 January 2007 - 9:24AM
PR Newswire (US)
Nexavar Doubled Progression-Free Survival in Largest Advanced
Kidney Cancer Trial WEST HAVEN, Conn. and EMERYVILLE, Calif., Jan.
10 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced that the New England Journal of Medicine has published
their pivotal Phase III trial demonstrating that Nexavar(R)
(sorafenib) tablets doubled median progression-free survival (PFS)
in patients with advanced renal cell carcinoma (RCC), or kidney
cancer. The data, as assessed by independent radiologic review, are
from the Treatment Approaches in Renal Cancer Global Evaluation
Trial (TARGET) -- the largest randomized controlled trial ever
conducted in advanced RCC. (Photo:
http://www.newscom.com/cgi-bin/prnh/20070110/NYW150 )
"Historically, patients with kidney cancer have had limited
treatment options and there has been a particularly critical need
for new therapies to help patients with advanced disease," said
co-principal investigator Ronald Bukowski, M.D., Director of the
Experimental Therapeutics Program of The Cleveland Clinic Taussig
Cancer Center in Cleveland, OH. "This landmark study demonstrated
the efficacy, tolerability and clinical benefit of Nexavar, which
has rapidly become a valuable weapon against this devastating
disease." Based on these data, Nexavar was granted U.S. Food and
Drug Administration (FDA) approval for the treatment of patients
with advanced RCC, or kidney cancer, on December 20, 2005. Since
then, Nexavar has been approved in nearly 50 countries. "Nexavar
was the first new drug approved for patients with advanced kidney
cancer in over a decade," said Bill Bro, President and Chief
Executive Officer of the Kidney Cancer Association (KCA). "With the
advent of targeted therapies such as Nexavar, there has been
remarkable change -- patients are experiencing improved outcomes
without the toxic effects traditionally associated with
chemotherapy." Phase III Summary More than 900 patients with
advanced RCC were randomized one-to-one to receive either 400 mg
Nexavar or placebo orally twice a day in this randomized,
multi-national, placebo-controlled Phase III study. The endpoints
of the study are overall survival (OS), PFS, overall response rate
and safety. PFS measures the length of time that a patient lives
without evident tumor growth or death. PFS doubled to a median of
5.5 months in patients receiving Nexavar compared to 2.8 months for
patients receiving placebo (p < 0.001). This represented a 56%
reduction in the risk of progression (hazard ratio 0.44; 95% CI,
0.35 to 0.55) for patients on Nexavar versus placebo. All patient
subgroups examined benefited regardless of performance status or
risk group, including patients who had not received conventional
treatment with biologics, such as interleukin-2 or
interferon-alpha. In May 2005, due to the clinical and statistical
significance of the PFS data, the companies unblinded the trial and
announced that patients who were receiving placebo were allowed to
"cross over" to drug treatment. The first OS analysis conducted
immediately before cross-over found a 39% improvement in OS for
Nexavar patients (hazard ratio 0.72, p=0.018). A further OS
analysis performed six months following cross over was based on 367
survival events (patient deaths) that had occurred by November 30,
2005. Results showed a continued trend toward improved survival,
with a 23% reduction in the risk of death (19.3 months for Nexavar
patients versus 15.9 months for placebo patients; hazard ratio
0.77, p=0.02), despite the fact that nearly half of placebo
patients had "crossed over" to Nexavar. Patients continue to be
followed and a final survival analysis will be available in the
first half of 2007. The Phase III data published in NEJM have
previously been communicated at international scientific
congresses. 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-1,
VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET. Nexavar is currently
approved in nearly 50 countries, including the United States and in
the European Union, for the treatment of patients with advanced
kidney cancer. In addition, Nexavar is being evaluated by the
companies, international study groups, government agencies or
individual investigators as a single agent or combination treatment
in a wide range of cancers, including adjuvant RCC, advanced liver
cancer, metastatic melanoma, non-small cell lung cancer and breast
cancer. 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 is one of the world's
leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. Bayer
HealthCare generated sales amounting to some 9.4 billion euros and
employed 33,800 people worldwide in 2005. The company combines the
global activities of the Animal Health, Consumer Care, Diabetes
Care, and Pharmaceuticals divisions. The new Pharmaceuticals
division was established on January 1, 2006, and comprises the
former Biological Products and Pharmaceutical divisions. Bayer
HealthCare Pharmaceuticals now has three business units:
Hematology/Cardiology, Oncology and Primary Care. Bayer
HealthCare's aim is to discover and manufacture products that will
improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and
treating diseases. 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) is a registered trademark of Bayer AG, Germany.
http://www.newscom.com/cgi-bin/prnh/20070110/NYW150
http://photoarchive.ap.org/ DATASOURCE: Bayer Pharmaceuticals
Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett,
+1-203-812-2160, or Michael Diehl, +49-214-30-58532, both of Bayer
HealthCare; or Julie Wood of Onyx Pharmaceuticals, Inc.,
+1-510-597-6505; or Alicia Samuels of GCI Group, +1-212-537-8170
Web site: http://www.bayerpharma.com/ http://www.onyx-pharm.com/
http://www.nexavar.com/ http://www.curekidneycancer.org/
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