THOUSAND OAKS, Calif., Sept. 23, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that data from XGEVA® (denosumab) and Vectibix® (panitumumab) studies will be presented at the 2011 European Multidisciplinary Cancer Congress, Sept. 23 - 27, 2011, in Stockholm, Sweden.
"The data being presented at the 2011 European Multidisciplinary Cancer Congress reflect Amgen's ongoing commitment to advancing the understanding of cancer and developing novel therapies to treat it," said Willard H. Dere, M.D., senior vice president and international chief medical officer at Amgen. "New biomarker analyses for Vectibix reinforce the importance of patient selection when EGFR inhibitors are used in metastatic colorectal cancer, while data from the '147 study demonstrate the potential for XGEVA to be the first treatment to prevent the spread of prostate cancer to the bone."
SELECTED ABSTRACTS OF INTEREST
Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.
Denosumab and Bone Metastasis-free Survival in Men with Castrate-resistant Prostate Cancer: Subgroup Analyses From an International, Double-blind, Randomized, Phase 3 Trial
(Abstract 7003) Proffered Papers Session Genitourinary Malignancies – Prostate Cancer on Sunday, Sept. 25, 9:45 a.m. CEST, Hall A3
Data embargoed until 12:01 a.m. CEST on Sept. 24. Data to be highlighted in EMCC press program on Sept. 24 at 8:00 a.m. CEST, Room K21 (Level 1).
Denosumab Treatment for Giant Cell Tumor of Bone (GCTB) in Adolescent Patients: Interim Results from a Phase 2 Study
(Abstract 32LBA) Proffered Papers Session, Sarcoma on Tuesday, Sept. 27, 11:00 a.m. CEST, Hall T2
Pain Outcomes in a Randomized Phase 3 Clinical Trial of Denosumab vs Zoledronic Acid (ZA) in Patients with Solid Tumors and Bone Metastases
(Abstract 7004) Proffered Papers Session Genitourinary Malignancies – Prostate Cancer on Sunday, Sept. 25, 9:55 a.m. CEST, Hall A3
Safety and Efficacy of Panitumumab (pmab) in HPV Positive (+) and HPV Negative (-) Recurrent/Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN): Analysis of the Phase 3 SPECTRUM Trial
(Abstract 25LBA) Proffered Papers Session Head and Neck Cancer on Saturday, Sept. 24, 13:20 (1:20 p.m.) CEST, Hall K1
Evaluation of Individual Codon 12 and 13 Mutant (MT) KRAS Alleles as Prognostic and Predictive Biomarkers of Response to Panitumumab (pmab) in Patients With Metastatic Colorectal Cancer (mCRC)
(Abstract 33LBA) Proffered Paper Session Personalized Medicine on Sunday, Sept. 25, 10:30 a.m. CEST, Victoria Hall
ADDITIONAL XGEVA ABSTRACTS
Health Resource Utilization (HRU) Associated with Skeletal-related Events (SREs) by Tumor Type in Patients with Bone Metastases/lesions: European Analysis of a Prospective Multinational Observational Study
(Abstract 3613) Poster Session on Saturday, Sept. 24, 9:30 a.m. - 12:00 p.m. CEST
Effect of Denosumab Treatment on Prevention of Hypercalcemia of Malignancy in Cancer Patients with Metastatic Bone Disease
(Abstract 3051) Poster Session on Monday, Sept. 26, 9:30 a.m. - 12:00 p.m. CEST
Prevention of Skeletal-Related Events with Denosumab or Zoledronic Acid - Combined Analysis From 3 Registrational Trials
(Abstract 3061) Poster Session on Monday, Sept. 26, 9:30 a.m. - 12:00 p.m. CEST
ADDITIONAL VECTIBIX ABSTRACTS
Efficacy of Panitumumab Plus FOLFIRI Versus FOLFIRI Alone in Patients with Wild-type (WT) KRAS Metastatic Colorectal Cancer (mCRC) Treated with Prior Oxaliplatin or Bevacizumab Regimens: Results from 20050181.
(Abstract 6132) Poster Session on Sunday, Sept. 25, 9:30 a.m. - 12:00 p.m. CEST
Study 20050203/PRIME: Effect of Post-Progression Anti-epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody (mAb) Therapy in Patients (pts) with Wild-type (WT) KRAS Metastatic Colorectal Cancer (mCRC)
(Abstract 6143) Poster Session on Sunday, Sept. 25, 9:30 a.m. - 12:00 p.m. CEST
Randomized, Open-label, Phase 3 Study of Panitumumab (pmab) with FOLFOX4 vs FOLFOX4 Alone as 1st-line Treatment for Metastatic Colorectal Cancer (mCRC): the Role of Hypomagnesemia (hypomag) on Efficacy
(Abstract 6095) Poster Session on Sunday, Sept. 25, 9:30 a.m. - 12:00 p.m. CEST
Abstracts are available on the EMCC website at http://stockholm2011.ecco-org.eu/Programme.aspx. Late breakers and any abstracts that form part of the EMCC media programme will be posted on the day of presentation.
XGEVA is the first and only RANK Ligand inhibitor approved by the FDA indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a six month priority review by the FDA. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. XGEVA is the first novel bone metastases treatment for advanced cancer patients in nearly a decade. XGEVA is delivered as an every four week 120 mg subcutaneous injection and is not associated with renal toxicity or acute phase reactions.
XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.
XGEVA has been studied in over 7,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.
XGEVA Important Safety Information
XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels in patients at greater risk of developing hypocalcemia. Administer calcium and vitamin D in all patients (unless hypercalcemia is present). Advise patients to contact a healthcare professional for symptoms of hypocalcemia.
Osteocronosis of the jaw (ONJ) can occur in patients receiving XGEVA. Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.
Adverse reactions in patients receiving XGEVA included fatigue/asthenia, hypophosphatemia, nausea, dyspnea and diarrhea.
Please visit http://www.amgen.com for full U.S. prescribing information.
XGEVA Skeletal-Related Events Regulatory Status
The European Commission (EC) granted a Marketing Authorization for XGEVA for the prevention of SREs (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors. As part of the review, the EC also granted XGEVA one additional year of marketing protection based on the indication being considered new for denosumab and the significant clinical benefit offered by the product in comparison with existing therapies.
XGEVA is also approved in Canada for reducing the risk of developing SREs in patients with bone metastases from breast cancer, prostate cancer, non-small cell lung cancer, and other solid tumors. In Canada, XGEVA is not indicated for reducing the risk of developing SREs in patients with multiple myeloma.
Amgen has also submitted marketing applications for XGEVA in Mexico, Russia, and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited and a marketing application was submitted. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.
For more information on XGEVA, please visit www.XGEVA.com.
Vectibix injection for IV infusion is the first fully human anti-EGFR antibody approved by the U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix received accelerated approval in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC 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 mCRC is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Retrospective subset analyses of mCRC trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of mCRC with these mutations.
In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as a monotherapy for the treatment of patients with EGFR expressing mCRC with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens. Vectibix has been launched in more than 40 countries worldwide.
Important U.S. Product Safety Information
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 events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.
Important European Product Safety Information
For full prescribing information please see the Summary of Product Characteristics.
Vectibix is indicated as monotherapy for the treatment of patients with EGFR expressing, mCRC with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
Vectibix is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to the product and in patients with interstitial pneumonitis or pulmonary fibrosis.
Other adverse events of special importance associated with Vectibix and/or EGFR monoclonal antibody therapies include dermatologic related reactions, pulmonary complications, electrolyte disturbances and infusion related reactions (including rare reports with fatal outcome). Acute renal failure has been observed in patients who develop severe diarrhea and dehydration. Serious cases of keratitis and ulcerative keratitis have been rarely reported in the post-marketing setting. These events should be monitored carefully, see Summary of Product Characteristics for information on appropriate management of these adverse events.
Vectibix should not be used in combination with IFL chemotherapy or in combination with bevacizumab-containing chemotherapy.
Vectibix should not be administered in combination with oxaliplatin-containing chemotherapy to mCRC patients with mutant KRAS tumors or for whom KRAS tumor status is unknown.
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