The safety of IMLYGIC® (talimogene laherparepvec) was evaluated in 419 patients who received at least 1 dose of either IMLYGIC® (n = 292) or subcutaneously administered granulocyte-macrophage colony-stimulating factor (GM-CSF) (n = 127) in a phase 3, multicenter, open-label, randomized clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable. The median duration of exposure to IMLYGIC® was 23 weeks (5.3 months). Twenty-six patients were exposed to IMLYGIC® for at least 1 year.1,2,3
Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours. The most common adverse events reported (≥ 25%) in IMLYGIC®-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. The most common grade 3 or higher adverse reaction was cellulitis.1
Pyrexia, chills, and influenza-like illness can occur any time during IMLYGIC® treatment but were more frequent during the first 3 months of treatment.1
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions Reported with at Least a 5% Greater Incidence in Patients Treated with IMLYGIC® Compared to GM‑CSF in the Clinical Study1
Other adverse reactions associated with IMLYGIC® in the open-label, randomized study include glomerulonephritis, vitiligo, cellulitis, and oral herpes.1