Bayer and Onyx Provide Update on Phase 3 Trial of Nexavar in Patients With Non-Small Cell Lung Cancer

Feb 18, 2008, 00:00 ET from Bayer HealthCare Pharmaceuticals

    WAYNE, N.J. and EMERYVILLE, Calif., Feb. 18 /PRNewswire/ -- Bayer
 HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq:   ONXX)
 today announced that a Phase 3 trial evaluating Nexavar(R) (sorafenib)
 tablets in patients with non-small cell lung cancer (NSCLC) was stopped
 early following a planned interim analysis, when the independent Data
 Monitoring Committee (DMC) concluded that the study would not meet its
 primary endpoint of improved overall survival. The Phase 3 ESCAPE
 (Evaluation of Sorafenib, Carboplatin And Paclitaxel Efficacy in NSCLC)
 trial evaluated Nexavar when administered in combination with the
 chemotherapeutic agents carboplatin and paclitaxel in patients with
 non-small cell lung cancer (NSCLC). Safety events were generally consistent
 with those previously reported. However, higher mortality was observed in
 the subset of patients with squamous cell carcinoma of the lung treated
 with sorafenib and carboplatin and paclitaxel versus those treated with
 carboplatin and paclitaxel alone.
     Bayer and Onyx are providing information regarding this DMC
 recommendation to health authorities and those clinical investigators
 involved in studies of Nexavar. In addition, the companies will further
 review the findings of this analysis and DMC recommendation to determine
 what, if any, impact they have on other ongoing Nexavar lung cancer trials.
 Data from this study will be presented at an upcoming scientific meeting.
     "While we are disappointed in this outcome, Bayer and Onyx remain
 committed to our comprehensive pan-tumor clinical trial program for
 Nexavar. Nexavar has proven significant clinical benefit for patients with
 liver cancer and advanced kidney cancer and we will continue to investigate
 its potential across a wide variety of tumors," said Susan Kelley, MD, vice
 president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals.
     ESCAPE Trial Design
     This multicenter, randomized, double-blind, placebo-controlled Phase 3
 study enrolled more than 900 patients with non-small cell lung cancer at
 more than 140 clinical sites in North America, South America, Europe and
 the Asia Pacific region. The primary endpoint was overall survival, and
 secondary endpoints included progression-free survival, tumor response,
 patient quality of life and safety. Participating patients had not received
 any prior systemic anti-cancer treatment for their lung cancer and
 enrollment was open to patients with all histologies (or cell types) of
 NSCLC, including those with squamous cell carcinoma or adenocarcinomas.
     Patients were randomized to receive 400 mg of oral Nexavar twice daily
 or placebo, in addition to two chemotherapeutic agents -- carboplatin and
 paclitaxel -- for up to six cycles. Subsequently, patients continued in a
 maintenance phase where Nexavar or placebo was administered as a single
 agent until study drug was discontinued due to progression of tumor or side
     Comprehensive NSCLC Program
     Bayer and Onyx have a comprehensive program of clinical trials studying
 Nexavar for the treatment of NSCLC in a variety of patient populations and
 in combination with other anti-cancer regimens. These include a second
 ongoing Phase 3 study, known as NExUS (NSCLC research Experience Utilizing
 Sorafenib), in previously untreated patients, administering Nexavar in
 combination with two chemotherapeutics commonly used in Europe, gemcitabine
 and cisplatin. In addition, a Phase 2 trial sponsored by a cooperative
 study group in the United States in patients who have failed two or more
 therapeutic regimens has also completed enrollment. There are also multiple
 Phase 2 studies in patients who have experienced disease progression
 despite treatment with one prior therapeutic regimen.
     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,
     Nexavar is currently approved in more than 30 countries for liver
 cancer and in more than 60 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
 other cancers, including metastatic melanoma, breast cancer and as an
 adjuvant therapy for kidney cancer and 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, 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.
 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. Most common
 adverse events reported with Nexavar in patients with unresectable HCC were
 diarrhea, fatigue, abdominal pain, weight loss, anorexia, nausea and
 hand-foot skin reaction. Grade 3/4 adverse events were 45% for Nexavar vs.
 32% 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 or call 1.866.NEXAVAR
     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(R) (sorafenib) tablets, a small molecule drug. For more information
 about Onyx, visit the company's website at
     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 our annual and interim reports
 filed with the Frankfurt Stock Exchange. 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 the timing,
 progress and results of the clinical development, safety, 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,
 2006, 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) (sorafenib) tablets is a registered trademark of Bayer
 HealthCare Pharmaceuticals, Inc.

SOURCE Bayer HealthCare Pharmaceuticals