Investigational Melanoma Agent Meets Endpoint in Phase 3 Trial

March 20, 2013

New Phase 3 trial data found that Amgen's investigational melanoma agent talimogene laherparepvec met its primary endpoint of durable response rate for the treatment of unresected stage IIIB, IIIC, or IV melanoma. Researchers observed a statistically significant difference of 16 percent in DRR in patients treated with talimogene laherparepvec. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven, however the company notes that interim data is favorable. 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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