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Amgen Inc Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In Melanoma

Tuesday, 19 Mar 2013 06:04pm EDT 

Amgen Inc announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically difference was observed in DRR: 16% in the talimogene laherparepvec arm versus 2% in the GM-CSF arm. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance. The frequent adverse events observed in this trial were fatigue, chills and pyrexia. The common serious adverse events include disease progression, cellulitis and pyrexia. Among the various types of skin cancer, melanoma is the aggressive and also the serious. Although melanoma accounts for less than 5% of skin cancer cases, or 132,000 cases globally each year, melanoma accounts for 75% of all skin cancer deaths. 

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19 Dec 2014