Amgen Presents Positive Phase 3 Results from Talimogene Laherparepvec Metastatic Melanoma Study

Amgen

today announced detailed results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). The results will be presented as an oral presentation at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract No. LBA9008).  The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR with 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm (95 percent CI, 12-21 percent, versus 95 percent CI, 0-5 percent, p<0.0001). The overall response rate was 26 percent with talimogene laherparepvec as compared to six percent for GM-CSF.  A trend toward overall survival (HR = 0.79, 95 percent CI, 0.61-1.02) was also observed at a predefined interim analysis. "These are the first data from a controlled trial of oncolytic immunotherapy to demonstrate activity in melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are pleased with the results of this