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Abstracts are currently available on the
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 (
Vectibix is the first fully human anti-epidermal growth factor receptor (EGFR) antibody approved by the
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.
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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
CONTACT: Amgen, Thousand Oaks