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., May 15 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced it will present new data from the Company's oncology portfolio of approved and investigational cancer products at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Fla. from May 29 to June 2, 2009. Data will be presented from several programs, including Vectibix(R) (panitumumab), Neulasta(R) (pegfilgrastim), Aranesp(R) (darbepoetin alfa), denosumab, conatumumab (AMG 655), dulanermin (rhApo2L/TRAIL) and AMG 479.
"Data presented at this year's ASCO continue to support the scientific view that the angiogenesis, apoptosis, growth regulation, bone metabolism and hematopoiesis pathways hold promise for the treatment of cancer or the treatment side effects," said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen. "These results further our understanding of the clinical and biological effects of the key molecules in development targeting these pathways. The clinical benefits and safety profiles of some of these molecules will be further evaluated when results from four Phase 3 oncology studies and five Phase 2 programs across multiple tumor types are unveiled by the end of this year."
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 Amgen research. Updated data will be presented at the meeting.
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 April 17, 2009 press release, findings from the STEPP trial, a randomized, Phase 2 trial evaluating preventive therapy for a common, severe skin rash associated with Vectibix treatment, will be included in the June 1st ASCO Press Program.
Lead Author: Cohn A
Abstract No. 4067 (Sunday, May 31, 2009, 8:00am-12:00pm)
Lead Author: Vermorken JB
Abstract No. 6050 (Monday, June 1, 2009, 8:00am-12:00pm)
Lead Author: Mitchell E
Abstract No. CRA4027 (Monday, June 1, 2009, 8:00am-12:00pm)
Lead Author: Greil R
Abstract No. 4085 (Sunday, May 31, 2009, 8:00am-12:00pm)
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.
Lead Author: Tan H
Abstract No. 6626 (Saturday, May 30, 2009, 2:00pm-6:00pm)
Lead Author: Barron R
Abstract No. 9561 (Monday, June 1, 2009, 8:00am-12:00pm)
Lead Author: Hecht JR
Abstract No. 4072 (Sunday, May 31, 2009, 8:00am-12:00pm)
Aranesp(R) (darbepoetin alfa)
Final data from the DAHANCA-10 Aranesp pharmacovigilance trial in head and neck cancer patients will be presented.
Lead Author: Overgaard J
Abstract No. 6007 (Saturday, May 30, 2009, 4:15pm-4:30pm)
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.
Lead author: Thomas D
Abstract No. 10510 (Monday, June 1, 2009, 5:15pm-5:30pm)
As part of Amgen's mechanistic approach to targeted cancer therapies, the Company's apoptosis program is focused on the development of highly selective therapies to induce cancer cell death. In cancer, the dysregulation of apoptosis is critical in the development and survival of tumors. The Company's apoptosis program includes conatumumab (AMG 655), a molecule designed to target death receptor 5 (DR5) to induce apoptosis selectively in cancer cells, and dulanermin (rhApo2L/TRAIL), a recombinant human protein that targets death receptors 4 and 5 (DR4 and DR5) and induces apoptosis in preclinical models. Amgen is developing dulanermin in collaboration with Genentech. These molecules are being studied for their potential as anticancer therapies in a variety of tumors.
Lead Author: Kindler HL
Abstract No. 4501 (Saturday, May 30, 2009, 8:30am-8:45am)
Lead Author: Saltz L
Abstract No. 4079 (Sunday, May 31, 2009, 8:00am-12:00pm)
Lead Author: Rougier P
Abstract No. 4130 (Sunday, May 31, 2009, 8:00am-12:00pm)
Lead Author: Yee L
Abstract No. 4129 (Sunday, May 31, 2009, 8:00am-12:00pm)
Amgen's growth regulation program is focused on targeting cellular pathways that regulate cell pre-production, survival, migration and invasion, which cancer cells often escape. Amgen is targeting the IGF-1R pathway, among others, to develop novel approaches that may lead to the development of anticancer therapies.
Lead Author: McCaffery I
Abstract No. 3545 (Saturday, May 30, 2009, 8:00am-12:00pm)
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 U.S. Food and Drug Administration (FDA) in 2002 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia the same year.
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 U.S. Food and Drug Administration (FDA) in September 2001 for the treatment of anemia associated with chronic renal failure (CRF), for patients on dialysis and patients not on dialysis. In July 2002, the FDA approved weekly dosing of Aranesp for the treatment of anemia caused by concomitantly administered chemotherapy in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.
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.
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). Amgen is studying denosumab in numerous tumor types across the spectrum of cancer induced bone disease. Over 11,000 patients are currently enrolled in denosumab oncology clinical trials testing the drug for bone loss associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer.
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 www.amgen.com.
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Contacts: Amgen, Thousand Oaks Christine Regan, 805-447-5476 (media, cancer therapeutics) Ashleigh Koss, 805-313-6151 (media, cancer supportive care) Lisa Rooney, 805-447-6437 (media, denosumab) Arvind Sood, 805-447-1060 (investors)
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