THOUSAND OAKS, Calif., May 15, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that it will present data from several studies of both pipeline and marketed products at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting from May 31 to June 4 in Chicago.
"The data that we are presenting at ASCO demonstrate great progress with our effort to develop treatments that will help patients with advanced cancers," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen. "As a company rooted in biology, we are in a strong position to develop innovative therapies that fight cancer through new pathways such as immunotherapy and to leverage biomarkers to advance personalized medicine."
Meeting delegates who visit Amgen's booth will also have the opportunity to learn more about Amgen's legacy of manufacturing expertise – from research and development to delivery of complex biological therapies.
Abstracts are currently available on the ASCO website at http://abstract.asco.org/.
ABSTRACTS OF INTEREST INCLUDE:
The results of the primary analysis of the pivotal trial of talimogene laherparepvec, an investigational oncolytic immunotherapy for the treatment of melanoma, including interim overall survival data, will be presented.
Results from a Phase 1 study in pediatric patients with acute lymphoblastic leukemia (ALL) will be presented for blinatumomab, the first of a new investigational class of agents designed to harness the body's cytotoxic T cells to kill cancer cells.
Three new analyses of trials studying Vectibix in combination with FOLFOX, an oxaliplatin-based chemotherapy, as a first-line treatment for metastatic colorectal cancer (mCRC) will be presented. Presentations include two analyses of the Phase 3 PRIME ('203) trial: an updated overall survival analysis and an analysis of the treatment effect by RAS/RAF status, respectively. The Phase 3 PRIME ('203) trial evaluated Vectibix plus FOLFOX versus FOLFOX alone in patients with wild-type KRAS mCRC. An analysis by RAS status of the Phase 2 PEAK ('509) trial comparing the efficacy of Vectibix in combination with FOLFOX to the efficacy of bevacizumab in combination with FOLFOX in patients with wild-type KRAS mCRC will also be presented.
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy derived from herpes simplex virus type-1 designed to selectively replicate within cancer cells and to produce GM-CSF to enhance systemic antitumor immune responses. Talimogene laherparepvec is injected directly into tumor tissue and replicates until the membranes of the cancer cells rupture, thereby destroying them in a process known as oncolysis. The virus contained in these cells as well as potential tumor antigens are then released locally along with GM-CSF, a white blood cell growth factor that the virus is engineered to express. This is intended to activate antigen presenting cells and elicit a systemic immune response to kill tumor cells throughout the body.
Blinatumomab is an investigational bi-specific T cell engager (BiTE®) antibody designed to direct the body's cytotoxic T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells with cancer cells. Blinatumomab is the first of the BiTE antibodies, and Amgen has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL).
Vectibix is the first fully human anti-epidermal growth factor receptor (EGFR) antibody 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 single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin and irinotecan chemotherapy regimens. Approval is based on progression-free survival; no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Important U.S. Product Information
Vectibix is indicated as a single agent for the treatment of EGFR-expressing, mCRC with disease progression on or following fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing mCRC is based on progression-free survival. Currently, no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibix is not indicated for the treatment of patients with KRAS mutation-positive mCRC or for whom KRAS mCRC status is unknown. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13.
WARNING: DERMATOLOGIC TOXICITY and INFUSION REACTIONS
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. [See Dosage and Administration (2.1), Warnings and Precautions (5.1), and Adverse Reactions (6.1)].
Infusion Reactions: Severe infusion reactions occurred in approximately one percent of patients. Fatal infusion reactions occurred in postmarketing experience. [See Dosage and Administration (2.1), Warnings and Precautions (5.2), and Adverse Reactions (6.1, 6.3)].
The most common adverse reactions (> 20%) of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, diarrhea, including diarrhea resulting in dehydration.
The most serious adverse reactions 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.
To see the full Vectibix Prescribing Information, visit www.vectibix.com.
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, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping people around the world in the fight against serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
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CONTACT: Amgen, Thousand Oaks
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