Nexavar in Combination With Chemotherapy Demonstrates Activity in Patients With Advanced Breast Cancer in Two Phase 2 Studies
12 December 2009 - 8:45AM
PR Newswire (US)
- Data Presented at 32nd Annual CTRC-AACR San Antonio Breast Cancer
Symposium - WAYNE, N.J. and EMERYVILLE, Calif., Dec. 11
/PRNewswire-FirstCall/ -- Bayer HealthCare Pharmaceuticals and Onyx
Pharmaceuticals, Inc. (NASDAQ:ONXX) today announced results from
two collaborative group-sponsored randomized, double-blind,
placebo-controlled Phase 2 trials were presented at the 32nd Annual
San Antonio Breast Cancer Symposium (SABCS). The first of these
studies evaluated Nexavar® (sorafenib) tablets in combination with
chemotherapy agent capecitabine and the second study evaluated
Nexavar in combination with paclitaxel. "Onyx and Bayer are
encouraged by these results as they suggest Nexavar may have
potential as a combination therapy for advanced breast cancer
patients in both the first and second-line setting," said Todd
Yancey, M.D., senior vice president of clinical development at
Onyx. "These findings, in particular the statistically significant
results demonstrated with Nexavar in combination with capecitabine,
are the basis for a registrational Phase 3 program that is expected
to begin next year." Nexavar in Combination with Capecitabine The
randomized, double-blind, placebo-controlled Phase 2 study
evaluated Nexavar in combination with the oral chemotherapeutic
agent, capecitabine, in 229 patients. These patients had locally
advanced or metastatic HER-2 negative breast cancer and had
received no more than one prior chemotherapy in this setting.
Patients receiving capecitabine plus Nexavar had a 74 percent
improvement in progression-free survival as compared to those who
received chemotherapy alone. The increase in median
progression-free survival of capecitabine plus Nexavar versus
capecitabine plus placebo was statistically significant (median 6.4
months vs. 4.1 months, HR=.576, p=0.0006). In a post-hoc, subgroup
analysis of first-line patients, the combination of capecitabine
plus Nexavar significantly extended progression-free survival to
7.6 months compared to 4.1 months (HR= 0.498, p=0.0022). In a
second post-hoc subgroup analysis of second-line patients, the
combination of Nexavar and capecitabine significantly extended
progression-free survival 5.7 months compared to 4.1 months
(HR=0.652, p=0.0339) The primary endpoint of the study was
progression-free survival. Secondary endpoints included overall
survival, time-to-progression, and safety. Patients were randomized
to receive 400 mg of oral Nexavar or matching placebo twice daily,
in addition to 1000 mg/m2 of capecitabine. Overall, treatment with
capecitabine plus Nexavar did not result in any new side effects.
Common grade 3 treatment-related adverse events included hand-foot
skin reaction (45%), diarrhea (5%), dyspnea (5%), neutropenia (4%)
and mucositis (1%). Top-line results from this study were
previously presented at the joint 15th European CanCer Organisation
(ECCO) and 34th European Society for Medical Oncology (ESMO)
Multidisciplinary Congress. Nexavar in Combination with Paclitaxel
The randomized, double-blind, placebo-controlled Phase 2 study
evaluated Nexavar in combination with the chemotherapeutic agent,
paclitaxel, in 237 patients. Patients were randomized to receive
400 mg of oral Nexavar or matching placebo twice daily, in addition
to paclitaxel, given at 90 mg/m2 weekly for three weeks followed by
one week of rest. These patients had locally recurrent or
metastatic HER-2 negative breast cancer and had not received prior
chemotherapy in this setting. The primary endpoint of the study was
progression-free survival (PFS). The PFS in patients receiving
paclitaxel plus Nexavar compared to patients receiving paclitaxel
plus placebo was 6.9 months vs. 5.6 months (HR=0.788, P=0.0857,
one-sided). Secondary endpoints included overall survival,
time-to-progression, and safety. The difference in
time-to-progression of paclitaxel plus Nexavar versus paclitaxel
plus placebo was statistically significant, 8.1 months vs. 5.6
months (HR= 0.674, P=0.017 one-sided). There were no new toxicities
observed with the combination and adverse events were clinically
manageable. Common grade 3 treatment-related adverse events
included hand-foot skin reaction (30%), asthenia (7%), neutropenia
(10%) and anemia (10%). "The results from these two trials fuel our
interest in exploring Nexavar in multiple settings through our
comprehensive clinical program," said Dimitris Voliotis, vice
president, Global Clinical Development Oncology, Bayer HealthCare.
"Breast cancer is the second leading cause of cancer-related death
in women, and we are committed to evaluating Nexavar's role in this
often underserved patient population." About the Nexavar Clinical
Program in Breast Cancer These two studies are part of a clinical
development program known as TIES (Trials to Investigate the
Effects of Sorafenib in Breast Cancer). Nexavar is being evaluated
in collaboration with investigators and cooperative groups in four
large randomized Phase 2 trials for patients with advanced breast
cancer and in a variety of treatment settings. In addition to these
two studies, there 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 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. (i)(ii)(iii) Nexavar's
Differentiated Mechanism 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. Nexavar inhibits both the tumor cell and
tumor vasculature. In preclinical studies, Nexavar has been shown
to inhibit 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, PDGFRB, 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 lung, ovarian and colorectal cancer and
as an adjuvant therapy for liver and kidney cancer. Important
Safety Considerations For Patients Taking Nexavar Based on the
currently approved U.S. package insert for the treatment of
patients with unresectable hepatocellular carcinoma and 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. In HCC patients,
bleeding with a fatal outcome from any site was reported in 2.4%
for Nexavar and 4% in placebo. The incidence of treatment-emergent
cardiac ischemia/infarction was 2.7% for Nexavar vs. 1.3% for
placebo. In RCC patients, 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 adverse events greater
than or equal to 20% related to Nexavar for both HCC and RCC were
fatigue, weight loss, rash/desquamation, hand-foot skin reaction,
alopecia, diarrhea, nausea, and abdominal pain. Grade 3/4 adverse
events in HCC and RCC patients, respectively, were 45% for Nexavar
vs. 32% for placebo and 38% for Nexavar and 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
information about Nexavar including U.S. Nexavar prescribing
information, visit http://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. Bayer HealthCare Pharmaceuticals
comprises the following business units: Women's Healthcare,
Diagnostic Imaging, General Medicine, which includes Cardiology and
Primary Care and Specialty Medicine, which includes Hematology,
Oncology and Multiple Sclerosis. 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® (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, a targeted alpha-folate inhibitor, is currently
in Phase 1 testing. For more information about Onyx, visit the
company's website at http://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 http://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 also contains "forward-looking
statements" of Onyx within the meaning of the federal securities
laws. These forward-looking statements include without limitation,
statements regarding timing, 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. Reference
should be made to Onyx's Annual Report on Form 10-K for the year
ended December 31, 2008, 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. (i) American Cancer Society,
2007 Global Cancer Facts and Figures Report (ii) American Cancer
Society, 2009 Global Cancer Facts and Figures Report (iii)
Estimates of the cancer incidence and mortality in Europe in 2006,
Annals of Oncology, 2007 Mar;18(3):581-92 DATASOURCE: Onyx
Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals Inc.
CONTACT: Media, David Freundel of Bayer HealthCare Pharmaceuticals,
+1-973-866-6082; or Lori Murray of Onyx Pharmaceuticals, Inc.,
+1-510-590-0800, or Investors, Julie Wood of Onyx Pharmaceuticals,
Inc., +1-510-597-6505 Web Site: http://www.onyx-pharm.com/
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