Amgen has announced the publication of primary results from the Phase 3 OPTiM study.
The data demonstrates 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 favour of talimogene laherparepvec.
“Oncolytic virus immunotherapy may become a new approach to melanoma treatment, and the OPTiMstudy demonstrated durable responses in talimogene laherparepvec treated patients with metastatic melanoma,” said lead investigator Howard L. Kaufman, M.D., associate director for Clinical Science at the Rutgers Cancer Institute of New Jersey and president of the Society for Immunotherapy of Cancer. “Talimogene laherparepvec may offer a potential new treatment option for patients with this aggressive form of skin cancer.”
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.
OPTiM trial data provides strong evidence supporting the local and distant effects of talimogene laherparepvec
“While there have been some important new treatment options in recent years, the incidence of melanoma has risen dramatically, and we need additional approaches for treating advanced disease,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The OPTiM trial data provide strong evidence supporting the local and distant effects of talimogene laherparepvec and its potential to stimulate a systemic anti-tumor immune response.”
The OPTiM data serve as the basis of a Biologics License Application which has been accepted for review by the US Food and Drug Administration (FDA), and a Marketing Authorisation 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 27 October 2015.
