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June 2, 2014
07:48 EDTAMGNAmgen presents new data that support potential of talimogene laherparepvec
Amgen announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. Data from the 19 patients in the Phase 1b combination study showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab. Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue. The pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate. Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented. The results demonstrated a 4.4 month improvement in overall survival which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors.The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
News For AMGN From The Last 14 Days
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April 17, 2015
09:20 EDTAMGNInsulet weakness creates buying opportunity, says Wedbush
Wedbush believes that Insulet's growth should accelerate as the year progresses, driven by increased adoption of its unique, programmable insulin pump and the launch of Amgen's (AMGN) Neulasta On-Body Delivery System.
April 15, 2015
18:56 EDTAMGNOn The Fly: After Hours Movers
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17:06 EDTAMGNAmgen confirms FDA approval of Corlanor
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16:40 EDTAMGNFDA approves Amgen's Corlanor to treat heart failure
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April 6, 2015
05:19 EDTAMGNAmgen announces EC approval of Vectibix in combination with Folfiri
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