Amgen announced that the Company will present eight IMLYGIC
(talimogene laherparepvec) abstracts, including data from the Phase 3
trial and new data from its Phase 1b combination trial with Merck's
anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research (SMR), to be held on Nov. 18-21 in San Francisco.
The Phase 1b data on IMLYGIC in combination with an investigational use of Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma has been accepted as a late-breaking abstract.
IMLYGIC is a genetically modified herpes simplex type 1 virus that is
injected directly into tumors. IMLYGIC 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. However, the exact mechanism of action is unknown.
IMLYGIC is the first oncolytic viral therapy approved by the FDA
based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC
is a genetically modified oncolytic viral therapy indicated for the
local treatment of unresectable cutaneous, subcutaneous, and nodal
lesions in patients with melanoma recurrent after initial surgery.
IMLYGIC has not been shown to improve overall survival or have an effect
on visceral metastases.
