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|Amgen Highlights Biomarker and Preclinical Data to be Presented at American Association for Cancer Research (AACR) Annual Meeting|
|Key RANK Ligand Preclinical Data and Vectibix Biomarker Data Will Be Presented
THOUSAND OAKS, Calif., April 12, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced that results from several preclinical studies investigating potential new cancer agents and a comprehensive biomarker analysis will be presented at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C. from April 17 - 21, 2010.
Results from a biomarker analysis of the pivotal Phase 3 Vectibix(R) (panitumumab) "408" trial will be presented. The trial used massively parallel, next-generation sequencing technology to investigate whether mutations in nine genes are predictive of response to Vectibix in metastatic colorectal cancer. In addition, results will be presented from a preclinical study of RANK ligand (RANKL) inhibitor against mammary tumor formation in mouse models.
Additional presentations include data from Amgen's emerging oncology therapeutics portfolio, which provide further experience and biologic understanding from key research areas. Amgen currently has 16 molecules in development for oncology in preclinical through Phase 3 clinical trials.
"The data presented at AACR highlight the important scientific advances that are being made in cancer research," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "We hope and expect that these important preclinical studies will permit us to develop dramatically improved therapies for patients suffering from malignant disease."
Presentations and Abstracts of Interest
Abstracts are available and can be viewed on the AACR Web site at http://www.aacr.org/. Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.
-- EDUCATIONAL SESSION: RANK ligand (RANKL) inhibitors for the treatment
of skeletal complications of cancer
About Vectibix(R) (panitumumab)
Vectibix is the first fully human anti-EGFR approved by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer (mCRC). Vectibix was approved in the United States in September 2006 as a monotherapy for the treatment of patients with EGFR expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS genes after failure of standard chemotherapy regimens. Vectibix has been launched in over 20 countries, including Switzerland, Australia and Canada. Applications in the rest of the world are pending.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix has not shown a treatment benefit for patients whose tumors had KRAS mutations in codon 12 or 13.
Important Product Safety Information
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products.
The most common adverse events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.
The most serious adverse events of Vectibix are pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.
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/.
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