Imlygic is the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with advanced melanoma
The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending that Imlygic ( Talimogene laherparepvec ) be granted approval 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, the first in a class of novel agents known as oncolytic immunotherapies, administered via intralesional injection, is designed to cause the death of tumor cells and to initiate an anti-tumor immune response.
The positive CHMP opinion was based on a global, randomized, open-label phase 3 trial evaluating the safety and efficacy of Imlygic in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor ( GM-CSF ).
In the 436-patient study, Imlygic significantly improved durable response rate ( DRR ), the primary endpoint of the trial, in the intent-to-treat population.
DRR is defined as the percent of patients with complete response ( CR ) or partial response ( PR ) maintained continuously for a minimum of six months.
A key secondary endpoint was overall survival.
The positive CHMP opinion reflects subgroup analyses where the effect on overall survival was largest in patients with unresectable melanoma that has not spread beyond the skin or lymph nodes.
The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness and injection-site pain.
Overall, 98% of these adverse reactions reported were mild or moderate in severity.
The most common grade 3 or higher adverse reaction was cellulitis.
Imlygic is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. It replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. Imlygic then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response.
The exact mechanism of action is unknown. ( Xagena )
Source: Amgen, 2015