THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor or GM-CSF.
The company said that the study met its primary endpoint of durable response rate or 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: 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm.
The analysis of overall survival or OS, a key secondary endpoint of the study, is event driven.
Amgen stated that a pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF and the OS data is expected to mature in late 2013 in line with previous guidance.
Commenting on Talimogene laherparepvec, the company said it is an investigational oncolytic immunotherapy designed to work in two important and complementary ways - to cause local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.
Copyright(c) 2013 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2013 AFX News
