Amgen announced that the European Commission has approved the use of IMLYGIC™
(talimogene laherparepvec) for the treatment of adults with
unresectable melanoma that is regionally or distantly metastatic (Stage
IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral
disease. IMLYGIC is the first oncolytic immunotherapy to demonstrate
therapeutic benefit for patients with metastatic melanoma in a Phase 3
clinical trial.
IMLYGIC is derived from the herpes simplex type 1 virus (HSV-1) ,
commonly called the cold sore virus. IMLYGIC has been modified to
replicate within tumors and to produce the immune stimulatory protein
human granulocyte-macrophage colony-stimulating factor (GM-CSF).
Administered via intralesional injection, IMLYGIC is designed to cause
the death of tumor cells and initiate an anti-tumor immune response.
Melanoma remains a significant public health concern in the European Union (EU), with an estimated 22,000 deaths from the disease in 2012.
While melanoma is curable when detected in the early stages, metastatic
melanoma continues to be one of the most difficult-to-treat cancers
because it is highly aggressive and complex. Even with
recent new options in immune-oncology, a large number of patients with
metastatic melanoma still do not respond to treatment.
The most commonly reported treatment-related adverse events were
fatigue, chills, pyrexia, nausea, influenza-like illness and
injection-site pain. Overall, 98 percent of these adverse reactions
reported were mild or moderate in severity. The most common grade 3 or
higher adverse reaction was cellulitis. No fatal treatment-related
adverse events occurred.
