Amgen's Melanoma Drug Study Misses Secondary Endpoint
Amgen reported that the Phase III trial evaluating its melanoma drug met its primary endpoint with top-line results but missed its secondary endpoint of overall survival.
The global, open-label, randomized, Phase III trial assessed 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). The primary endpoint of durable response rate was met but not the secondary endpoint of overall survival. However, the company said results showed a strong trend in the favor of talimogene laherparepvec.
Sean Harper, EVP of research and development at Amgen, said, “We remain encouraged that the study met its primary endpoint of achieving durable responses in patients with metastatic melanoma. We missed statistical significance on the secondary endpoint of overall survival but the strong trend in survival benefit supports further research of talimogene laherparepvec to better understand its role in melanoma, both as a single-agent and in combination with other therapies.”
Melanoma is the most aggressive and serious form of skin cancer, causing the most number of skin cancer deaths in the U.S. The disease is characterized by excessive growth of melanocytes — the cells which are responsible for skin pigments.
About 132,000 cases of melanoma occur worldwide every year.
Talimogene laherparepvec is an investigative oncolytic immunotherapy that selectively replicates in tumors but not normal tissue. The drug induces an immune response to target cancer cells that have metastasized. The drug is injected directly into tumors to allow it to replicate inside and cause lysis, a process where the target cell ruptures and dies. Lysis releases tumor-derived antigens together with GM-CSF that can stimulate a system-wide immune response so white blood cells can seek out and target cancer cells that have spread throughout the patient’s body.
The company acquired talimogene laherparepvec as part of its Biovex acquisition deal in 2011.