Berlin, Germany. — Sep. 23, 2009
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced the full results from their first collaborative group-sponsored randomized, double-blind, placebo-controlled Phase 2 trial showing that Nexavar® (sorafenib) tablets in combination with the oral chemotherapeutic agent, capecitabine, significantly extended progression-free survival in patients with advanced breast cancer. The data were presented at the joint 15th European CanCer Organisation (ECCO) and 34th European Society for Medical Oncology (ESMO) Multidisciplinary Congress in Berlin.
Jose Baselga, M.D., chairman and professor of medicine at Vall d’Hebron Institute of Oncology in Barcelona, scientific chairman of SOLTI and the principal investigator of this study, reported that patients receiving Nexavar plus capecitabine had a 74 percent improvement in the time they lived without their disease progressing compared to those who received the chemotherapy alone. The difference in median progression-free survival of Nexavar plus capecitabine versus capecitabine plus placebo was statistically significant, 6.4 months vs. 4.1 months (HR=.576, p=0.0006).
“Onyx and Bayer have built a strong foundation with Nexavar in treating unresectable liver cancer and advanced kidney cancer- - both disease areas with a previously unmet treatment need,” said Todd Yancey, M.D., vice president of clinical development at Onyx. “These new results signify another step in understanding the potential role of Nexavar in breast cancer.”
The study evaluated Nexavar in combination with the oral chemotherapeutic, capecitabine, in patients with locally advanced or metastatic HER-2 negative breast cancer. Overall, treatment with Nexavar plus capecitabine was tolerable and resulted in no new side effects. Common grade 3 or 4 treatment-related adverse events included hand-foot skin reaction, diarrhea, dyspnea, neutropenia and mucositis.
Breast Cancer Trial Design
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. 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 twice daily for 14 days followed by a seven day rest from capecitabine.
“These data represent a potentially significant advance in the treatment of breast cancer, which is the second leading cause of cancer-related death in women,” said Dimitris Voliotis, vice president, Global Clinical Development Oncology, Bayer HealthCare. “In addition to the positive signal generated in this trial, Onyx and Bayer are committed to the development of Nexavar in breast cancer in a variety of settings through a robust clinical program.”
About the Nexavar Clinical Program in Breast Cancer
In a clinical development program known as Trials to Investigate the Effects of Sorafenib in Breast Cancer (TIES), Nexavar is being evaluated in a variety of treatment settings for patients with breast cancer in collaboration with investigators and cooperative groups. Among these clinical trials are three ongoing randomized Phase 2 studies, including a trial to evaluate Nexavar plus paclitaxel in the first-line setting, 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 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 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 ≥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 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. For more information about Onyx, visit the company’s website at www.onyx-pharm.com.
About SOLTI (Spanish Collaborative Group for the Study, Treatment and Other Experimental Strategies in Solid Tumors)
Founded in 1995, SOLTI is a collaborative group that leads cutting-edge clinical research in breast cancer to answer important questions that will lead to a reduction in the morbidity and mortality in breast cancer, and to carry out trials with new molecules and targeted therapeutics in oncology. SOLTI’s network of high level oncology services spans Spain and Portugal promoting excellence in breast cancer care.
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 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.
iAmerican Cancer Society, 2007 Global Cancer Facts and Figures Report
iiAmerican Cancer Society, 2009 Global Cancer Facts and Figures Report
iiiEstimates of the cancer incidence and mortality in Europe in 2006, Annals of Oncology, 2007 Mar;18(3):581-92