Bayer and Onyx Initiate Phase 3 Trial of Nexavar in Patients With Non-Responsive Thyroid Cancer
October 23 2009 - 1:30AM
PR Newswire (US)
WAYNE, N.J. and EMERYVILLE, Calif., Oct. 23 /PRNewswire-FirstCall/
-- Bayer HealthCare Pharmaceuticals, Inc. and Onyx Pharmaceuticals,
Inc. (NASDAQ: ONXX) today announced the companies have begun
enrolling patients in an international Phase 3 trial to evaluate
Nexavar® (sorafenib) tablets for the treatment of patients with
radioactive iodine-refractory, locally advanced or metastatic
differentiated thyroid cancer. This Phase 3 trial was started based
on the results from Phase 2 clinical trials evaluating Nexavar in
patients with advanced thyroid cancer. "Patients with thyroid
cancer who failed to respond to surgical or radiotherapies, have
limited treatment options to help them manage their disease," said
Dimitris Voliotis, vice president, Nexavar clinical development,
Bayer HealthCare Pharmaceuticals. "Recognizing this unmet need, we
are evaluating Nexavar in this special patient population." Phase 3
Trial Design The DECISION (stuDy of sorafEnib in loCally advanced
or metastatIc patientS with radioactive Iodine refractory thyrOid
caNcer) trial is an international, multicenter, randomized,
placebo-controlled study that will enroll approximately 400
patients with locally advanced or metastatic, radioactive
iodine-refractory, differentiated thyroid cancer (papillary,
follicular and Hurthle cell) who have received no prior systemic
therapy. Patients will be randomized to receive 400 mg of oral
Nexavar twice daily or matching placebo. Patients will continue on
treatment until disease progression, toxicity, non-compliance or
withdrawal of consent. At the time of progression, patients
receiving placebo will have an option to cross over to Nexavar at
the discretion of the investigator, based on the patient's clinical
status. The primary endpoint of the study is progression-free
survival as defined by Response Evaluation Criteria in Solid Tumors
(RECIST). Secondary endpoints include overall survival, time to
progression and response rate. The safety and tolerability of the
two treatment groups will also be compared. The study will be
conducted at sites in the United States, Europe, Asia, and Japan.
For information about enrolling in the study, please visit
http://www.clinicaltrials.gov/. Phase 2 Trial Results Updated
results from a single institution, investigator sponsored Phase 2
open-label study in 55 patients with metastatic, iodine refractory,
thyroid cancer treated with Nexavar 400 mg twice daily were
presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting, May 29-June 3, 2009 Orlando, FL, by Marcia Brose,
M.D., Ph.D., an assistant professor of Hematology/Oncology and
Otorhinolaryngology in the Abramson Cancer Center at the University
of Pennsylvania, Philadelphia, PA, U.S.A. In 50 evaluable patients,
18 (36 percent) had a partial response per RECIST criteria. Updated
survival results on the first 30 patients enrolled into the study
demonstrated that across all histologies the median
progression-free survival (PFS) was 63 weeks and the median overall
survival was 140 weeks. The most common adverse events (AE) seen in
the trial were hand-foot skin reaction, rash, fatigue,
stomatitis/mucositis, weight loss, and musculoskeletal pain, and
were predominantly grade 1 or 2. Dr. Brose and Martin J.
Schlumberger, Institut Gustave-Roussy, Villejuif, France, are the
lead investigators on the Phase 3 trial. "Based on the positive
signal generated in the Phase 2 trial, the initiation of this Phase
3 represents progress in exploring the full potential of Nexavar in
a variety of treatment settings and tumor types," said Todd Yancey,
M.D., vice president of clinical development at Onyx. "Building on
our successful foundation of treating unresectable liver cancer and
advanced kidney cancer, we are hopeful that this Phase 3 trial will
lead to a new treatment option for patients with non-responsive
thyroid cancer." About Thyroid Cancer Thyroid cancer, one of the
few cancers that has increased in incidence over the past several
years, is the sixth most common cancer in women and about three
times as many women as men get thyroid cancer.(1) There are more
than 140,000 new cases of thyroid cancer and more than 35,000
people die worldwide each year.(2) Nexavar's Differentiated
Mechanism Nexavar targets both the tumor cell and tumor
vasculature. In preclinical studies, Nexavar has been shown to
target 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 more than 80 countries
for the treatment of patients with liver cancer and in more than 90
countries for the treatment of patients with advanced kidney
cancer. 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 breast cancer, colorectal cancer, lung
cancer, ovarian cancer, and as an adjuvant therapy for liver
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
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
unit of Bayer HealthCare LLC, a division of Bayer AG. One of the
world's leading, innovative companies in the healthcare and medical
products industry, Bayer HealthCare combines the global activities
of the Animal Health, Consumer Care, Diabetes Care, and
Pharmaceuticals divisions. In the U.S., Bayer HealthCare
Pharmaceuticals comprises the following business units: Women's
Healthcare, Diagnostic Imaging, Specialized Therapeutics,
Hematology/Cardiology and Oncology. 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. 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. (1) American Cancer Society (2) Globocan
2002, World Health Organization, www-dep.iarc.fr/ DATASOURCE: Onyx
Pharmaceuticals, Inc.; Bayer HealthCare Pharmaceuticals, Inc.
CONTACT: Media, David Freundel of Bayer HealthCare Pharmaceuticals,
+1-973-305-5310; or Lori Murray, +1-510-597-6394; or Investors,
Julie Wood, +1-510-597-6505, both of Onyx Pharmaceuticals, Inc. Web
Site: http://www.nexavar.com/ http://www.onyx-pharm.com/
http://www-dep.iarc.fr/
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