Lilly initiates Ph III GBM Enzastaurin trial

US drug major Eli Lilly has initiated a Phase III study of enzastaurin, its investigational, targeted oral agent, in the treatment of relapsed glioblastoma multiforme, an aggressive and malignant form of brain cancer.

The randomized, open-label registration study will enroll 397 patients and compare the efficacy, safety and tolerability of the oral serine-threonine kinase inhibitor versus CeeNU (lomustine), a common oral chemotherapy for GBM. The primary endpoints of this study will be progression-free and overall survival. Lilly will also analyze tissue samples to identify potential biomarkers as a basis for correlating patient response to clinical outcomes.

The Indianapolis-headquartered firm said that the agent is designed to suppress tumor growth through multiple mechanisms, noting that preclinical data indicate it may reduce the cell's ability to reproduce, as well as increase apoptosis and inhibit growth of tumor-induced blood supply.