Lilly launches phase III trial of Enzastaurin

One of the deadliest and rarest forms of cancer is the focus of a Phase III study initiated by Eli Lilly and Company today.

Enzastaurin, an investigational, targeted, oral agent, will be evaluated at more than 100 sites worldwide for the treatment of relapsed glioblastoma multiforme (GBM), an aggressive and malignant form of brain cancer.

The enzastaurin glioblastoma Phase III trial (STEERING - Study Evaluating Enzastaurin in Recurrent Glioblastoma) is a randomized, open label registration study in recurrent GBM, which will compare the efficacy, safety and tolerability of enzastaurin, taken orally, versus CeeNU(R) (lomustine[CCNU]), a common oral chemotherapy used to treat this disease. Dr. Howard Fine, chief of Neuro-Oncology at the National Cancer Institute, will be the principal investigator for this study that will enroll 397 patients. The primary endpoints of this study will be progression-free survival and overall survival. In this study, Lilly will analyze tissue samples to identify potential biomarkers as a basis for correlating patient response to clinical trial outcomes.

Enzastaurin is an oral serine-threonine kinase inhibitor that is designed to suppress tumor growth through multiple mechanisms. Preclinical data indicate it may reduce the cell's ability to reproduce (cell proliferation), increase the natural death of the tumor cells (apoptosis), and inhibit tumor- induced blood supply (angiogenesis). Enzastaurin has been shown to inhibit signaling through the PKC-B and PI3K/AKT pathways. These pathways have been shown to be activated in a wide variety of cancers. In addition to glioblastoma, enzastaurin is also being studied in multiple other tumor types, including non-Hodgkin's lymphoma, colorectal cancer, non-small cell lung cancer, pancreatic cancer, and mantle cell lymphoma.