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8-K - FORM 8-K - ONYX PHARMACEUTICALS INC | f56108e8vk.htm |
Exhibit 99.1
Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell
Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
Positive Secondary Endpoint of Progression Free Survival;
Clinical Trial Program in Lung Cancer Ongoing
Clinical Trial Program in Lung Cancer Ongoing
Wayne, NJ and Emeryville, CA June 14, 2010 Bayer HealthCare Pharmaceuticals and Onyx
Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that the final analysis of the Phase 3 NExUS
(NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib)
tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the
study did not meet its primary endpoint of improving overall survival in the first-line setting.
NExUS evaluated Nexavar versus placebo in combination with two chemotherapeutic agents, gemcitabine
and cisplatin. A positive secondary endpoint of progression-free survival (PFS) was observed in
the trial. The safety and tolerability of the treatment triplet was as expected and did not show
any new or unexpected toxicities. Data from this study are expected to be presented at an upcoming
scientific meeting.
Nexavar is currently marketed worldwide for the treatment of hepatocellular carcinoma (HCC), or
liver cancer, and advanced renal cell carcinoma (RCC), or kidney cancer.
Enrollment in NExUS commenced in February 2007. In 2008, based on the results seen in a previous
Nexavar first-line NSCLC Phase 3 trial, the NExUS study protocol was amended to stop enrolling and
treating squamous cell carcinoma patients. Of the squamous cell patients who were enrolled in the
NExUS trial before the amendment, a higher mortality was observed. This finding was consistent
with what was seen in the previous trial.
Bayer and Onyx will further review the findings of this analysis to determine what, if any, impact
these data might have on other ongoing clinical trials evaluating the safety and efficacy of
Nexavar.
Bayer and Onyx are disappointed with these results, in particular, for patients who are suffering
from this deadly disease, said Dr. Dimitris Voliotis, Vice President, Global Clinical Development
Oncology, Bayer HealthCare. We are confident in our clinical trial program exploring Nexavars
potential in a variety of tumor types, including lung cancer. Based on encouraging data from a
recently presented prospective biomarker trial and Phase 2 signal-generating lung cancer studies,
we believe its critical to continue our evaluation of Nexavar in combination with targeted agents
and as a monotherapy in later lines of treatment in lung cancer patients.
Nexavar is being evaluated by the companies and individual investigators in a variety of treatment
settings for patients with non-small cell lung cancer, including a Phase 3 monotherapy study in the
third- and fourth-line setting and Phase 2 studies in combination with other therapies in the
second-line setting.
NExUS Trial Design
This Phase 3, randomized, double-blind, placebo-controlled study evaluated Nexavar (sorafenib)
tablets in combination with the chemotherapeutic agents, gemcitabine and cisplatin, in
treatment-naïve non-small cell lung cancer patients. The primary endpoint was overall survival,
and secondary endpoints included progression-free survival, tumor response and safety. Patients
were randomized to receive 400 mg of oral Nexavar or matching placebo twice daily, in addition to
gemcitabine and cisplatin for up to six cycles. Subsequently, patients continued in a maintenance
phase where Nexavar or placebo was administered as a single agent. The study enrolled
approximately 900 patients from sites throughout Europe, South America, Asia Pacific and the Middle
East.
About Non-Small Cell Lung Cancer (NSCLC)1
Non-small cell lung cancer accounts for 85-90% of diagnosed lung cancers and is a disease in which
malignant (cancer) cells form in the tissues of the lung. It is characterized by several types of
lung cancers, each of which grow and spread in different ways, including: squamous cell carcinoma,
adenocarcinoma, and large cell carcinoma.
Every year 1.4 million people worldwide will be diagnosed with lung cancer. There are nearly
205,000 new cases in the United States and approximately 375,000 new cases in Europe each year.
Annual deaths as a result of non small cell lung cancer are estimated at 160,000 in the United
States and 342,000 in Europe.
Nexavars Differentiated Mechanism
Nexavar, an oral anti-cancer therapy, is currently approved in more than 90 countries for liver
cancer and in more than 95 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 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 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, thyroid, breast, 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 ³20% 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 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 worlds 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: Womens Healthcare, Diagnostic
Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which
includes Hematology, Oncology and Multiple Sclerosis. The companys 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,
and ONX 0912, an oral proteasome inhibitor, are currently in Phase 1 testing. For more information
about Onyx, visit the companys 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 Bayers 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 Onyxs Annual
Report on Form 10-K for the year ended December 31, 2009, filed with the Securities and Exchange
Commission under the heading Risk Factors and Onyxs 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.Ferlay J, et al., GLOBOCAN 2002. Cancer Incidence, Mortality and Prevalence Worldwide. IARC
CancerBase No.5, Version 2.0. IARCPress, Lyon, 2004. Available at: http://www-dep.iarc.fr.
Contacts:
David Freundel
Media contact
Bayer HealthCare Pharmaceuticals
(973) 305-5310
Media contact
Bayer HealthCare Pharmaceuticals
(973) 305-5310
Julie Wood
Investor contact
Onyx Pharmaceuticals, Inc.
(510) 597-6505
Investor contact
Onyx Pharmaceuticals, Inc.
(510) 597-6505
Lori Murray
Media contact
Onyx Pharmaceuticals
(510) 597-6394
Media contact
Onyx Pharmaceuticals
(510) 597-6394