Disappointing results with Amgen’s talimogene laherparepvec in metastatic melanoma

Leading independent biotech firm Amgen (Nasdaq: AMGN) has released mixed top-line results from the primary overall survival (OS) analysis of a Phase III 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).

Results showed that, while the primary end point of durable response rate was met (as previously reported; The Pharma Letter March 16), the secondary endpoint of OS was not, 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.

ISI Group analyst Mark Schoenebaum quoted by Reuters said the drug's failure to significantly improve survival rates could affect its chances for approval and limit its commercial opportunity as a single therapy.