Talimogene laherparepvec Phase III OPTiM study results in metastatic melanoma published in Journal of Clinical Oncology- Amgen

Amgen has announced the publication of primary results from the Phase III OPTiM study in the Journal of Clinical Oncology (JCO). The data published in JCO, which were previously presented at the Annual Meetings of the American Society of Clinical Oncology ( ASCO ) in 2013 and 2014, demonstrated a significantly higher durable response rate (DRR) in patients with unresected stage IIIB, IIIC or IV metastatic melanoma receiving the investigational oncolytic immunotherapy talimogene laherparepvec compared to those who received granulocyte-macrophage colony-stimulating factor (GM-CSF). Results showed that the primary endpoint of DRR was met, however the secondary endpoint of overall survival (OS) was not met, although there was a strong trend in favor of talimogene laherparepvec.

The most frequent adverse events (AEs) observed in this study were chills, pyrexia, injection-site pain, nausea, flu-like symptoms and fatigue. The most common serious AEs included disease progression, cellulitis and pyrexia. No treatment-related deaths were observed.

The OPTiM data serve as the basis of a Biologics License Application which has been accepted for review by the FDA, and a Marketing Authorization Application in the European Union for talimogene laherparepvec for the treatment of adults with regionally or distantly metastatic melanoma. The FDA has set a review goal date under the Prescription Drug User Fee Act of Oct. 27, 2015.