On April 4, 2014 Amgen reported top-line results from the primary overall survival (OS) analysis of a 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) (Press release Amgen, APR 4, 2014, View Source;p=RssLanding&cat=news&id=1915897 [SID:1234500366]). Results showed that, while the primary end point of durable response rate was met (as previously reported), the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec (p=0.051). The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and to initiate an immune response to target cancer that has metastasized, or spread to other areas of the body.
The global, randomized, open-label Phase 3 trial enrolled patients with unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec every two weeks through direct tumor injection or GM-CSF subcutaneously for the first 14 days of each 28-day cycle, for up to 18 months.
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.

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