T Vec fails to meet OS endpoint in Phase III trial for Metastatic Melanoma - Amgen

Amgen has announced top-line results from the primary overall survival (OS) analysis of a Phase III trial in Metastatic Melanoma, which evaluated the efficacy and safety of T Vec (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). Results showed that, while the primary end point of durable response rate was met, the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec.

The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis. 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.