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Amgen Highlights Data to Be Presented at ASCO
New Vectibix(R) (Panitumumab) Combination Chemotherapy Data
New Data Reinforce Importance of Infection Prevention in Chemotherapy Patients
Oncology Pipeline Continues to Advance With New Data in Multiple Tumor Types
THOUSAND OAKS, Calif.,
"Data presented at this year's
Selected Abstracts of Interest
Abstracts are available and can be viewed on the ASCO Web site at
www.asco.org. Identified below are selected abstracts of interest on
Final efficacy and safety results will be presented from the PRECEPT trial evaluating Vectibix in combination with FOLFIRI. Consistent with evidence from panitumumab monotherapy findings, it appears that metastatic colorectal cancer (mCRC) patients with wild-type KRAS tumors have better outcomes than patients with KRAS mutated tumors when treated with Vectibix in combination with FOLFIRI. This may be due to KRAS having a predictive and/or prognostic effect which is currently being evaluated in ongoing randomized trials.
As detailed in the ASCO
-- Results from panitumumab (pmab) regimen evaluation in colorectal
cancer to estimate primary response to treatment (PRECEPT):
Second-line treatment with pmab and FOLFIRI by tumor KRAS status
Lead Author: Cohn A
Abstract No. 4067 (
-- An analysis of safety in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) receiving chemotherapy (CT) with or without panitumumab (pmab) in a phase 3 clinical trial (SPECTRUM)
Lead Author: Vermorken JB
Abstract No. 6050 (
-- Final STEPP results of prophylactic versus reactive skin toxicity (ST) treatment (tx) for panitumumab (pmab)-related ST in patients (pts) with metastatic colorectal cancer (mCRC)
Lead Author: Mitchell E
Abstract No. CRA4027 (
-- Updated analysis of a phase 2 study (20060314) of panitumumab (pmab) with FOLFIRI as first-line treatment of patients (pts) with metastatic colorectal cancer (mCRC)
Lead Author: Greil R
Abstract No. 4085 (
Neutropenia is a common and potentially dangerous side effect of myelosuppressive chemotherapy leading to a heightened risk of infection, sometimes life-threatening, among people with cancer. New data evaluate the risk of mortality in cancer patients experiencing febrile neutropenia (neutropenia with fever) based on clinical practice. Another study compares the effectiveness of prophylactic versus delayed use of granulocyte colony-stimulating factors (G-CSFs), including NEUPOGEN(R) (filgrastim) and Neulasta, on neutropenia-related hospitalizations based on clinical practice.
-- Evaluating risk of hospitalization with G-CSF use in real-world
Lead Author: Tan H
Abstract No. 6626 (
-- Risk of mortality in patients with cancer experiencing febrile neutropenia
Lead Author: Barron R
Abstract No. 9561 (
-- Pegfilgrastim in colorectal cancer (CRC) patients (pts) receiving every-two-week (Q2W) chemotherapy (CT): Long-term results from a phase 2 study
Lead Author: Hecht JR
Abstract No. 4072 (
Aranesp(R) (darbepoetin alfa)
Final data from the DAHANCA-10 Aranesp pharmacovigilance trial in head and neck cancer patients will be presented.
-- Randomized study of darbepoetin alfa as modifier of radiotherapy in
patients with primary squamous cell carcinoma of the head and neck
(HNSCC): Final outcome of the DAHANCA-10 trial
Lead Author: Overgaard J
Abstract No. 6007 (
Researchers will present data from the denosumab oncology development program, including an oral presentation of final Phase 2 data looking at the effect of denosumab on the treatment of giant cell tumor (GCT) of the bone, a rare locally aggressive tumor associated with significant skeletal morbidity. Composed of stromal and osteoclast-like giant cells, these tumors contain the protein, RANK Ligand, a key mediator of osteoclast activity. Data from this study provide proof-of-concept for specifically targeting the RANK Ligand pathway.
-- Denosumab treatment of giant cell tumor of bone: results of an open
label phase 2 study
Lead author: Thomas D
Abstract No. 10510 (
As part of
-- A phase 1b study to evaluate the safety and efficacy of AMG 655 in
combination with gemcitabine (G) in patients with metastatic
pancreatic cancer (PC)
Lead Author: Kindler HL
Abstract No. 4501 (
-- Safety and efficacy of AMG 655 plus modified FOLFOX6 (mFOLFOX6) and bevacizumab (B) for the first-line treatment of patients (pts) with metastatic colorectal cancer (mCRC)
Lead Author: Saltz L
Abstract No. 4079 (
-- A phase 1b/2 trial of AMG 655 and panitumumab (pmab) for the treatment (tx) of metastatic colorectal cancer (mCRC): Safety results
Lead Author: Rougier P
Abstract No. 4130 (
-- Phase 1b study of recombinant human Apo2L/TRAIL plus irinotecan and cetuximab or FOLFIRI in metastatic colorectal cancer (mCRC) patients (pts): Preliminary results
Lead Author: Yee L
Abstract No. 4129 (
-- Analysis of biomarkers during early phase clinical development of AMG
479, an investigational fully human monoclonal antibody antagonist of
type 1 insulin-like growth factor receptor (IGF-1R)
Lead Author: McCaffery I
Abstract No. 3545 (
Vectibix is indicated as a single agent for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal carcinoma after 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, metastatic colorectal carcinoma is based on progression-free survival. Currently no data demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibix Important Product Safety Information
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to less than or equal to grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.
Neulasta was approved by the
Neulasta Important Product Safety Information
Ruptured spleen (including fatal cases) and a serious lung problem called acute respiratory distress syndrome have been reported. Call your doctor or seek emergency care right away if you have abdominal or shoulder tip pain, shortness of breath, trouble breathing, or a fast rate of breathing. In rare cases, serious allergic reactions can occur, causing shortness of breath, wheezing, dizziness, swelling around the mouth or eyes, fast pulse, sweating, and hives. Sometimes these symptoms could come back within days after stopping treatment for the allergic reaction. If you start to have any of these symptoms, call your doctor or seek emergency care right away. Sickle cell crises have also been reported.
In a clinical study, mild to moderate bone pain occurred in 31 percent of the patients taking Neulasta and in 26 percent of the patients taking a placebo injection. In most cases, bone pain was controlled with a non-narcotic pain reliever, such as acetaminophen. Other common side effects reported by patients in the study taking either Neulasta or placebo were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.
Aranesp was approved by the
Aranesp Important Product Safety Information
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.
-- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
-- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
-- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
-- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
-- Discontinue following the completion of a chemotherapy course.
Aranesp is contraindicated in patients with uncontrolled hypertension.
Denosumab is the first fully human monoclonal antibody in late stage
clinical development that specifically targets RANK Ligand, the essential
regulator of osteoclasts (the cells that break down bone).
This news release contains forward-looking statements that are based on
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fully described in the
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Arvind Sood, 805-447-1060 (investors)