Amgen’s IMLYGIC (talimogene laherparepvec) is the first oncolytic immunotherapy to show evidence of therapeutic benefit in patients with metastatic melanoma in a Phase III clinical trial. As a result, the company has announced that the European Commission approved IMLYGIC for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no brain, lung, bone or other visceral disease.
IMLYGIC (talimogene laherparepvec) derives from the herpes simplex type 1 virus (HSV-1), also known as the cold sore virus. The compound — to be administered via intralesional injection — has been designed to replicate inside tumors and produce the immune stimulatory protein human granulocyte-macrophage colony-stimulating factor (GM-CSF) to kill tumor cells, triggering an anti-tumor immune response.
“As the first oncolytic immunotherapy authorized in the European Union, the approval of IMLYGIC is an important milestone for this new class of drugs, bringing patients with a rare and deadly form of skin cancer a much needed new treatment option,” Sean E. Harper, M.D., who is the Executive V. President of Research and Development at Amgen, in a press release. “By igniting the body’s own immune system IMLYGIC can initiate an anti-tumor immune response, providing meaningful and durable response rates in the early stage metastatic melanoma patient.”
While melanoma is curable when diagnosed in its early stages, metastatic melanoma continues to resist as one of the hardest cancers to treat due to its highly aggressive and complex characteristics. Numerous patients with metastatic melanoma remain unresponsive to treatment, despite the new therapeutic options in immune-oncology, making this condition a remaining public health concern in Europe – approximately 22,000 deaths were registered in 2012 alone.
Even though the pivotal study OPTiM did not evaluate the drug’s efficacy in individual subgroups, patients with no visceral disease experienced a considerable benefit from IMLYGIC treatment when compared to other patients with more advanced illness. Participants in the study reported fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain, as the most common adverse symptoms related to the treatment. However, 98% of the adverse reactions that patients reported were of mild or of moderate severity. The most common grade 3 or greater adverse reaction was cellulitis. Due to the exploratory nature of the analysis and based on the evidence generated by the study, it cannot be established just yet that IMLYGIC is associated with a direct overall survival (OS), but no fatalities occurred during the treatment.
This approval secures a centralized marketing authorization in the 28 EU countries plus Norway, Iceland and Liechtenstein – also members of the European Economic Area (EEA).