- News & Events
- Contact Us
New AMG 479 Phase 2 Data Show Antitumor Activity in Patients With Metastatic Pancreatic Cancer
AMG 479 Extended Progression-Free Survival And Overall Survival Compared To Gemcitabine Alone
AMG 479 Moving Into Phase 3 For Metastatic Pancreatic Cancer
THOUSAND OAKS, Calif., June 4, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced results from a small, randomized, placebo-controlled Phase 2 study indicating that adding AMG 479 to gemcitabine improved overall survival at six months (primary endpoint) and progression-free survival in patients with metastatic pancreatic cancer. The study, which also included a separate arm of conatumumab plus gemcitabine, is being presented in a Poster Discussion at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting. (Abstract Number: 4035)
AMG 479 is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF-1R). Signaling through IGF-1R plays an important role in the regulation of cell growth and survival.Conatumumab is an investigational fully human monoclonal antibody agonist that targets death receptor 5 (DR-5) and induces apoptosis - programmed cell death - in sensitive tumor cells.
"Pancreatic cancer has the worst survival of any solid tumor, and novel approaches to treat this disease are needed," said Dr. Hedy Kindler, M.D., associate professor of Medicine, medical director, Gastrointestinal Oncology and director, Mesothelioma Program, University of Chicago Medical Center. "In this study, AMG 479 demonstrated promising activity, extending progression-free survival three months and overall survival nearly three months compared to gemcitabine alone."
Patients were randomized to receive AMG 479 plus gemcitabine (n=40), conatumumab plus gemcitabine (n=41), or placebo plus gemcitabine (n=40).
The addition of AMG 479 to gemcitabine resulted in an overall survival rate at six months of 57 percent versus 50 percent with gemcitabine alone (95 percent CI, 41 - 70) and 39 percent versus 23 percent at 12 months (95 percent CI, 25 - 54). Median overall survival was 8.7 months versus 5.9 months in the gemcitabine arm (95 percent CI, 5.3 - 12.2). Patients receiving AMG 479 also experienced longer progression-free survival of 5.1 months versus 2.1 months (95 percent CI, 2.8 - 5.8).
The study also showed evidence of anti-tumor activity with conatumumab. Patients in the conatumumab arm experienced an overall survival rate at six months of 59 percent versus 50 percent (95 percent CI, 42 - 73) compared to gemcitabine alone and 20 percent versus 23 percent at 12 months (95 percent CI, 9 - 34). Patients receiving conatumumab experienced progression-free survival of 4.0 months versus 2.1 months compared to gemcitabine alone (95 percent CI, 3.3 - 5.0).
Both AMG 479 and conatumumab in combination with gemcitabine were tolerable. Grade 3 or higher adverse events observed included neutropenia (AMG 479/conatumumab/ placebo arm percentages 18/22/13), thrombocytopenia (15/17/8), abdominal pain (8/17/13), and fatigue (13/12/5).
Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. In 2009, there were more than 42,000 new cases of pancreatic cancer and 35,000 deaths from the disease. (i) Because diagnosis and intervention occur late in the course of this disease, the vast majority of patients already have metastatic disease at the time of diagnosis.(ii)
Amgen will hold an analyst/investor event at a local venue in Chicago on Monday, June 7 at 7:30 p.m. Central Time to discuss data presented at ASCO. A webcast of the event can be found on Amgen's website at http://www.amgen.com/, under Investors. The audio webcast will be archived and available for replay for at least 72 hours.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com/.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of June 4, 2010 and expressly disclaims any duty to update information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
CONTACT: Amgen, Thousand Oaks Leanne Madison: +1 (805) 603-9241 (media) Arvind Sood: +1 (805) 447-1060 (investors)
(i) National Cancer Institute. Available at: http://www.cancer.gov/cancertopics/types/pancreatic. Accessed April 15, 2010
(ii) National Cancer Institute: A Snapshot of Pancreatic Cancer. Available at: http://www.cancer.gov/aboutnci/servingpeople/snapshots/Pancreatic.pdf. Accessed April 15, 2010.