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July 15, 2013
19:14 EDTAMGNInterim results from Amgen Phase 2 study published
Amgen announced the Lancet Oncology published planned interim results from an international, open-label, Phase 2 clinical trial that is evaluating Xgeva in adults and skeletally mature adolescents diagnosed with giant cell tumor of bone. The study's primary endpoint is the safety profile of Xgeva. Secondary endpoints are the time to disease progression and the proportion of patients without any surgery at six months. Based on the investigators' interim assessment, 96% of patients with surgically unsalvageable GCTB had no disease progression after a median follow-up of 13 months. In those with salvageable GCTB whose surgery was associated with severe morbidity, 74% of patients required no surgery, and 62% of patients who had surgery underwent a less morbid procedure than planned. Overall, 72% of patients had objective tumor response, per protocol defined criteria, including 25% of patients who had an objective tumor response according to modified response evaluation criteria in solid tumors. The overall safety profile was found to be consistent with the known safety profile of Xgeva in patients with advanced cancer. Osteonecrosis of the jaw was reported in 1% of patients. Hypocalcemia adverse events, all non-serious, were reported in 5% of patients. The most common severe adverse events were low phosphate levels, back pain, pain in extremity, depression, musculoskeletal pain and anemia. Serious adverse events were reported in 9% of patients. No treatment-related deaths were reported.
News For AMGN From The Last 14 Days
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March 3, 2015
11:46 EDTAMGNLeerink biotech analyst holds an analyst/industry conference call
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March 2, 2015
16:49 EDTAMGNAmgen announces presentation of 15 abstracts from cardiovascular pipeline
Amgen announced that it will present 15 abstracts, including data evaluating, an investigational cholesterol-lowering medication, and Corlanor, an investigational drug for chronic heart failure, at the upcoming American College of Cardiology's 64th Annual Scientific Session, being held March 14-16 in San Diego. Repatha is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or "bad" cholesterol, from the blood. Corlanor is an oral drug that acts on the body's cardiac pacemaker to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization. Among the abstracts is a Late-Breaking Clinical Trial presentation of LDL-C lowering and major adverse cardiovascular event data after one year of treatment from the OSLER-1 and -2 studies in the Repatha program, and an oral presentation of long-term data from the OSLER-1 trial evaluating the safety and efficacy of Repatha after two years of treatment. Repatha data presentations also include a pooled safety analysis in over 6,000 patients from Phase 2 and 3 short- and long-term clinical trials. The Phase 3 results from the YUKAWA-2 study evaluating Repatha in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol will also be presented. Additionally, two analyses from the Phase 3 SHIFT study evaluating Corlanor will be presented. These data include an oral presentation on the efficacy profile of Corlanor in patients with chronic heart failure and angina, and a poster on whether the addition of Corlanor to optimized background therapy affects beta blocker usage.
16:15 EDTAMGNAmgen announces launch of Neulasta Delivery Kit
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09:19 EDTAMGNLigand data should establish superiority of Kyprolis, says Roth Capital
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07:17 EDTAMGNCelimmune announces Anti-IL-15 antibody licensing, option agreements with Amgen
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March 1, 2015
19:08 EDTAMGNAmgen ENDEAVOR study demonstrates superiority of Kyprolis over Velcade
Amgen and its subsidiary Onyx Pharmaceuticals announced the results from a planned interim analysis showing that the Phase 3 head-to-head clinical trial ENDEAVOR evaluating Kyprolis, carfilzomib, for Injection in combination with low-dose dexamethasone versus Velcade, bortezomib and low-dose dexamethasone met the primary endpoint of progression-free survival, PFS. Patients with relapsed multiple myeloma treated with Kyprolis lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade. The Kyprolis combination demonstrated superiority over the Velcade combination for secondary objectives of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature and continue to be monitored. Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rates of cardiac failure and renal failure for Kyprolis were comparable to those observed in the Phase 3 ASPIRE study. In ENDEAVOR, the rates for cardiac and renal failure were higher in the Kyprolis arm versus the Velcade arm. There was an increase in the incidence of hypertension and dyspnea in the Kyprolis arm compared to Velcade and that observed in the ASPIRE study.
February 27, 2015
09:03 EDTAMGNAmgen receives positive CHMP opinion for use of Vectibix
Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion to extend the marketing authorization for Vectibix to include combination with FOLFIRI as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer. About half of the patients with mCRC have wild-type RAS tumors.The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC.
07:37 EDTAMGNAmgen removed from the short-term buy list at Deutsche Bank
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07:26 EDTAMGNFDA PDUFA Date for Amgen's Ivabradine is February 27, 2015
February 26, 2015
16:35 EDTAMGNAmgen reports EMA acceptance of Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Kyprolis for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA. Kyprolis is a proteasome inhibitor, one of the classes of drugs used to treat multiple myeloma, an incurable blood cancer affecting approximately 89,000 people in Europe. Nearly all patients with the disease experience periods of remission, followed by relapses and eventually their disease becomes resistant to treatment. The MAA includes data from the Phase 3 ASPIRE trial as well as other relevant data.
February 25, 2015
16:50 EDTAMGNAmgen reports positive results from head-To-head Phase 3 study
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February 17, 2015
18:17 EDTAMGNJANA Partners gives quarterly update on stakes
NEW STAKES: NCR (NCR), Liberty Ventures (LVNTA), Solarcity (SCTY), Computer Sciences Corp (CSC), Salix (SLXP), and Applied Materials (AMAT). INCREASED STAKES: Hertz (HTZ), Valeant (VRX), Walgreens Boots Alliance (WBA), Rackspace (RAX), and HD Supply (HDS). DECREASED STAKES: AIG (AIG), Actavis (ACT), Charter (CHTR), AerCap (AER), and Energy Transfer Equity (ETE). LIQUIDATED STAKES: Equinix (EQIX), Cameron International (CAM), Dollar General (DG), QEP Resources (QEP), and Amgen (AMGN).
10:01 EDTAMGNCVS says PCSK9 inhibitors could cost system $150B annually
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