Amgen Discusses Details of the BLA for Talimogene Laherparepvec for Patients with Metastatic Melanoma

Amgen has presented data supporting the Biologics License Application (BLA) for talimogene laherparepvec monotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma at the joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC).

At the meeting, Amgen presented the results of the pivotal Phase III OPTiM study, which showed that talimogene laherparepvec monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a Phase III pivotal trial for patients with metastatic melanoma.

"The incidence of melanoma, the most serious form of skin cancer, has continued to rise over the last 30 years, even as many other cancers are in decline," said Sean E. Harper, executive vice president of R&D at Amgen. "Despite recent advances, there is still an unmet need in this disease. For this reason, the discussion about talimogene laherparepvec for the treatment of patients with metastatic melanoma is important. If approved, this novel agent could provide physicians and patients with an additional treatment option for this disease."

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumours (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumours where it replicates inside the tumour's cells causing the cell to rupture and die in a process called lysis. Then, the rupture of the cancer cells can release tumour-derived antigens, along with granulocyte-macrophage colony-stimulating factor (GM-CSF), which can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.

Amgen has in place a comprehensive clinical development program for talimogene laherparepvec in metastatic melanoma, which includes combination studies with checkpoint inhibitors in patients with late-stage disease and monotherapy prior to surgery (neoadjuvant) in patients with resectable disease. Furthermore, based on its clinical profile, talimogene laherparepvec has the potential to be studied in a variety of solid tumour types.