Amgen Oncology Highlights Upcoming Data Presentations at the 2007 European Conference on Clinical Oncology
New Data on Targeted and Supportive Care Cancer Therapies
Underscores Amgen's Commitment to Patients
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--Sept. 21, 2007--Amgen (NASDAQ:AMGN), today announced several presentations of interest featuring its portfolio of supportive care, and therapeutic agents being highlighted at the 14th European Conference on Clinical Oncology (ECCO) to be held in Barcelona, Spain, between Sept. 23 - 27, 2007.
Clinical data from an extended dosing study and safety and efficacy integrated patient level analyses of Aranesp(R) (darbepoetin alfa) will be presented, along with data from a study in cancer patients receiving Neulasta(R) (pegfilgrastim) as primary prophylaxis of neutropenia. Additionally, new biomarker data from a study in patients with metastatic colorectal cancer receiving Vectibix(TM) (panitumumab) will also be presented, along with early clinical data on AMG 386 - an investigational compound.
"We have made a commitment as a company to continue advancing the science and treatment of cancer," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "The breadth and diversity of the data we're presenting at ECCO this year reflects our commitment to exploring multiple pathways and serving the individual treatment needs of patients."
Aranesp(R) (darbepoetin alfa)
-- Evaluation of extended dosing intervals versus weekly dosing of darbepoetin alfa: A Phase 2 study in cancer patients with chemotherapy-induced anemia Abstract No. 1.141 (Wednesday, Sept. 26, 9:00 a.m. - 12:00 p.m., Poster Session, Level 0)
-- Evaluation of the association between hemoglobin events and safety outcomes in cancer patients with chemotherapy-induced anemia: an integrated analysis of patient-level data from 6 randomized, placebo-controlled trials of darbepoetin alfa Abstract No. 1.120 (Wednesday, Sept. 26, 9:00 a.m. - 12:00 p.m., Poster Session, Level 0)
-- Patient-level integrated analysis of data from 6 randomized, double-blind, placebo-controlled trials of darbepoetin alfa in patients with chemotherapy-induced anemia Abstract No. 1.104 (Wednesday, Sept. 26, 12:15 p.m. - 1:15 p.m., Poster Discussion, Room 113)
-- Study of the importance of Novel Erythropoiesis
Stimulating Protein (Aranesp(R)) for the effect of radiotherapy in
patients with primary squamous cell carcinoma of the head and neck
- the Danish Head and Neck Group DAHANCA 10 randomized trial (Tuesday, Sept. 25, 12:30 p.m. - 2:30 p.m., Presidential Session II, Forum)(1)
-- The data being presented has been submitted by an independent investigator-sponsored trial, which is part of Amgen's pharmacovigilance program for Aranesp. Amgen does not monitor the execution of investigator-initiated studies and does not control the data. --
-- Association of gene copy number of the epidermal growth factor receptor and clinical outcome in patients with metastatic colorectal cancer treated with panitumumab monotherapy Abstract No. 3019 (Monday, Sept. 24, 12:15 p.m. - 1:15 p.m., Poster Discussion, Room 115/116)
-- Analysis of KRAS mutations in patients with metastatic colorectal cancer receiving panitumumab monotherapy Abstract No. 3014 and 0007 (Tuesday, Sept. 25, 12:30 p.m. - 2:30 p.m., Presidential Session II, Forum)
-- Improved chemotherapy delivery in breast cancer
patients receiving pegfilgrastim primary prophylaxis compared with
current practice neutropenia management - results from an
integrated analysis (NeuCuP) Abstract No. 2.033 (Wednesday, Sept.
26, 10:45 a.m., Proffered
-- AMG 386, a selective angiopoietin
1/2-neutralizing peptibody, in combination with chemotherapy in
adult patients with advanced solid tumors (Thursday, Sept. 27, 8:00
a.m. - 11:00 a.m., Poster Session, Level 0)(1)
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 chemotherapy-induced anemia in patients with nonmyeloid malignancies and in March 2006, the FDA approved every-three-week dosing in these patients.
Important Aranesp Safety Information for Europe
Aranesp is contraindicated in patients with uncontrolled hypertension. Erythropoietic therapies may increase the risk of thrombotic and other serious events; regional guidelines should be referred to for target and maximum hemoglobin levels, and dose adjustment rules should be performed in line with regional prescribing information.
The most commonly reported side effects in clinical trials were arthralgia, edema, injection site pain, and thromboembolic event reactions.
Important Aranesp Safety Information for U.S.
Use the lowest dose of Aranesp(R) that will gradually increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion.
Aranesp(R) and other erythropoiesis-stimulating agents (ESAs) increased the risk for death and for serious cardiovascular events when administered to target a hemoglobin of greater than 12 g/dL
Cancer Patients: Use of ESAs
-- Shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Shortened overall survival and increased deaths attributed to disease progression at 4 months in patients with metastatic breast cancer receiving chemotherapy when administered to target a hemoglobin of greater than 12 g/dL,
-- Increased the risk of death when
administered to target a hemoglobin of 12 g/dL in patients with
active malignant disease receiving neither chemotherapy or
radiation therapy. ESAs are not indicated for this
Patients receiving ESAs pre-operatively for reduction of allogeneic red blood cell transfusions: A higher incidence of deep venous thrombosis was documented in patients receiving Epoetin alfa who were not receiving prophylactic anticoagulation. Aranesp(R) is not approved for this indication.
Aranesp is contraindicated in patients with uncontrolled hypertension.
Vectibix(TM) is indicated for the treatment of EGFr-expressing, metastatic colorectal cancer with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix for the treatment of EGFr-expressing, metastatic colorectal cancer is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Important Product Safety Information
Dermatologic toxicities, related to Vectibix(TM) blockade of EGF binding and subsequent inhibition of EGFr-mediated signaling pathways, were reported in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection, including sepsis, septic death, and abscesses requiring incisions and drainage. Vectibix may need to be withheld or discontinued for severe dermatologic toxicities.
Severe infusion reactions occurred with Vectibix in approximately 1 percent of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix, fatalities have occurred with other monoclonal antibody products. Severe infusion reactions require stopping the infusion and possibly permanently discontinuing Vectibix, depending on the severity and/or persistence of the reaction.
Neulasta (pegfilgrastim) is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia in 2002.
Important Product Safety Information
Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of these reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing anti-allergic treatment.
In a placebo-controlled trial, bone pain occurred at a higher incidence in Neulasta(R)-treated patients as compared to placebo-treated patients (31% vs 26%). The most common adverse events reported in either placebo- or active-controlled trials were consistent with the underlying cancer diagnosis and its treatment with chemotherapy, with the exception of bone pain.
Prescribers are recommended to consult regional prescribing information before prescribing Neulasta, particularly in relation to side-effects, precautions and contra-indications.
About AMG 386
AMG 386 is an investigational recombinant Fc-peptide fusion protein (peptibody) targeting angiopoietins. It is designed to bind angiopoietins, thereby inhibiting Tie2 dependent stimulation of endothelial cells. Angiopoietins, together with vascular endothelial growth factors (VEGFs), are key cytokines that regulate neovascularization.
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(1) Please note that abstract numbers were not available at the time of the release.
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Posted: September 2007