Amgen, a biotechnology company, has reported positive top-line results from a Phase III trial of talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma.
Talimogene laherparepvec is an investigational oncolytic immunotherapy that causes local lytic destruction of tumours while also stimulating a systemic anti-tumour immune response.
Amgen research and development executive vice president Dr Sean Harper said; "A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients."
Over 400 patients were randomised with either talimogene laherparepvec intralesionally every two weeks, or GM-CSF subcutaneously for the first 14 days of each 28 day cycle in 2:1 ratio in the study.
The primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months, was met.
A statistically significant difference in DRR with 16% in the talimogene laherparepvec arm, compared to 2% in the GM-CSF arm was observed in the study.
A key secondary endpoint of the open-label study, an analysis of overall survival (OS), is event-driven.
A favourable OS trend of talimogene laherparepvec was observed in a pre-planned interim analysis of DRR, as compared to GM-CSF. The OS data will mature by the end of 2013.
Image: Amgen Talimogene Laherparepvec Phase III study met the primary endpoint. Photo: Courtesy of Coolcaesar.