WAYNE, N.J. and EMERYVILLE, Calif., Feb. 24, 2011 /PRNewswire/ -- Bayer HealthCare
Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today
announced the companies have begun enrolling patients in a Phase 3
randomized, double-blind, placebo-controlled trial evaluating
Nexavar® (sorafenib) tablets in combination with the oral
chemotherapeutic agent, capecitabine, versus placebo plus
capecitabine for the treatment of patients with advanced breast
cancer. This Phase 3 trial was initiated based on the results from
a cooperative group-sponsored Phase 2 clinical trial evaluating
Nexavar in combination with capecitabine in patients with advanced
breast cancer.
"This Phase 3 trial is an important milestone in our development
of Nexavar as it provides an opportunity to evaluate Nexavar in
this patient population," said Dr. Dimitris
Voliotis, Vice President, Global Clinical Development
Oncology, Bayer HealthCare. "We look forward to continuing our
breast cancer clinical trial program, which includes two ongoing
cooperative group-sponsored Phase 2 trials."
Phase 3 Trial Design
The RESILIENCE (Phase 3 TRial Comparing CapecitabinE in
Combination with SorafenIb or PLacebo for Treatment of Locally
Advanced or MetastatIc HER2–Negative Breast CancEr) trial is a
randomized, double-blind, placebo-controlled Phase 3 study planned
to enroll 519 patients in more than 20 countries including
the United States, Brazil, Japan
and Australia. The study will
evaluate Nexavar in combination with capecitabine in patients with
locally advanced or metastatic HER-2 negative breast cancer who are
resistant to or have failed prior taxane and an anthracycline or
for whom further anthracycline is not indicated. The primary
endpoint of the study is progression-free survival. Secondary
endpoints include overall survival, time to progression, and
safety. For more information regarding this trial refer to
www.clinicaltrials.gov (NCT 01234337).
"Nexavar has demonstrated efficacy in advanced kidney cancer and
unresectable liver cancer and we are committed to evaluating
Nexavar in a variety of treatment settings and tumor types," said
Ted W. Love, M.D., Executive Vice
President and Head of Research and Development and Technical
Operations for Onyx Pharmaceuticals.
About the Nexavar Clinical Program in Breast Cancer
The TIES (Trials to Investigate the Effects
of Sorafenib in Breast Cancer) program is a cooperative
group-sponsored clinical development program evaluating Nexavar in
a variety of treatment settings for patients with breast cancer
conducted by investigators and oncology cooperative groups. Among
these clinical trials are two ongoing randomized Phase 2 studies,
including a trial to evaluate Nexavar plus gemcitabine or
capecitabine in the second-line setting following progression on
bevacizumab and a trial to evaluate Nexavar plus docetaxel and/or
letrozole in the first-line metastatic breast cancer 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
second leading cause of cancer-related death among women
(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). There are
approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year. More than 40,000 women in
the United States and more than
130,000 in Europe die of breast
cancer each year. (l)(ll)(lll)
About Nexavar
Nexavar is approved in the U.S. for the treatment of patients
with unresectable liver cancer and for the treatment of patients
with advanced kidney cancer. Nexavar inhibits both the tumor cell
and tumor vasculature. In preclinical studies, Nexavar has been
shown to inhibit members of two classes of kinases thought 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 100 countries.
Nexavar is also being evaluated by the companies, international
study groups, government agencies and individual investigators.
Important Safety Considerations For Patients Taking
Nexavar
NEXAVAR in combination with carboplatin and paclitaxel is
contraindicated in patients with squamous cell lung cancer. Nexavar
may cause fetal harm when administered to a pregnant woman. Women
of childbearing potential are advised to avoid becoming pregnant
and female patients should also be advised against breast-feeding
while receiving Nexavar.
Cardiac ischemia and/or myocardial infarction may occur.
Temporary or permanent discontinuation of Nexavar should be
considered in patients who develop cardiac ischemia and/or
myocardial infarction. Gastrointestinal perforation was an uncommon
adverse reaction and has been reported in less than 1% of patients
taking Nexavar.
Uncommon but serious adverse reactions including
keratoacanthomas/squamous cell cancer of the skin and Stevens -
Johnson Syndrome have been reported in clinical trials.
An increased risk of bleeding may occur following Nexavar
administration. If bleeding necessitates medical intervention,
consider discontinuation of Nexavar. Hypertension may occur early
in the course of treatment. Monitor blood pressure weekly during
the first 6 weeks and periodically thereafter and treat, as
required.
Hand-foot skin reaction and rash are common and management may
include topical therapies for symptomatic relief. In cases of any
severe or persistent adverse reactions, temporary treatment
interruption, dose modification, or permanent discontinuation of
Nexavar should be considered. Temporary interruption of Nexavar
therapy is recommended in patients undergoing major surgical
procedures.
Elevations in serum lipase and reductions in serum phosphate of
unknown etiology have been associated with Nexavar. Caution is
recommended when administering Nexavar with compounds that are
metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1
pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and
substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers. Concomitant
use of carboplatin and paclitaxel with sorafenib resulted in an
increase in paclitaxel exposure and an increase in Nexavar
exposure. Patients taking concomitant warfarin should be monitored
regularly for changes in prothrombin time, INR, or clinical
bleeding episodes. Nexavar exposure decreases when co-administered
with oral neomycin. Effects of other antibiotics on Nexavar
pharmacokinetics have not been studied.
Most common adverse reactions reported for Nexavar-treated
patients vs placebo-treated patients in unresectable HCC,
respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%),
abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia
(29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21%
vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.
Most common adverse reactions reported for Nexavar-treated
patients vs placebo-treated patients in advanced RCC, respectively,
were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%),
fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia
(27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions
were 38% vs 28%.
For information about Nexavar including U.S. Nexavar prescribing
information, visit www.nexavar.com or call 1.866.NEXAVAR
(1.866.639.2827).
About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based
pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of
Bayer AG. Bayer HealthCare is one of the world's leading,
innovative companies in the healthcare and medical products
industry, and combines the activities of the Animal Health,
Consumer Care, Diabetes Care, and Pharmaceuticals divisions. As a
specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals
provides products for Diagnostic Imaging, General Medicine,
Hematology, Neurology, Oncology and Women's Healthcare. The
company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and
treating diseases.
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(r) (sorafenib) tablets, a
small molecule drug that is currently approved for the treatment of
liver cancer and advanced kidney cancer. Additionally,
Nexavar is being investigated in several ongoing trials in a
variety of tumor types. Beyond Nexavar, Onyx has established
a development pipeline of anticancer compounds at various stages of
clinical testing, including carfilzomib, a next generation
proteasome inhibitor, that is currently being evaluated in multiple
clinical trials for the treatment of patients with relapsed or
relapsed/refractory multiple myeloma and solid tumors. ONX
0801, an alpha-folate receptor targeted inhibitor of the
thymidylate synthase, and ONX 0912, an oral proteasome inhibitor,
are currently in Phase 1 testing. For more information about
Onyx, visit the company's website at www.onyx-pharm.com.
Forward Looking Statements
This news release may contain forward-looking statements
based on current assumptions and forecasts made by Bayer Group or
subgroup 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 which are
available on the Bayer Web site at www.bayer.com. The company
assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or
developments.
This news release contains "forward-looking statements" of
Onyx within the meaning of the federal securities laws. These
forward-looking statements include without limitation, statements
regarding the progress and results of the clinical development,
safety, regulatory processes, commercialization efforts or
commercial potential of Nexavar. These statements are subject to
risks and uncertainties that could cause actual results and events
to differ materially from those anticipated, including risks
related to the development and commercialization of pharmaceutical
products. Any statements contained in this press release that are
not statements of historical fact may be deemed to be
forward-looking statements. Reference should be made to Onyx's
Annual Report on Form 10-K for the year ended December 31, 2010, 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® (sorafenib) tablets is a registered trademark of Bayer
HealthCare Pharmaceuticals, Inc.
(l) American Cancer Society, 2007 Global Cancer Facts and
Figures Report
(ll) American Cancer Society, 2009 Global Cancer Facts and
Figures Report
(lll) Estimates of the cancer incidence and mortality in
Europe in 2006, Annals of
Oncology, 2007 Mar;18(3):581-92
SOURCE Onyx Pharmaceuticals, Inc.; Bayer HealthCare
Pharmaceuticals Inc.