Lilly begins phase 3 trial of enzastaurin to treat brain cancer

By E. Janene Geiss

Philadelphia, March 9 - Eli Lilly and Co. said Thursday that one of the deadliest and rarest forms of cancer is the focus of a phase 3 study that it is initiating.

Enzastaurin, an investigational targeted oral agent, will be evaluated at more than 100 sites worldwide for the treatment of relapsed glioblastoma multiforme, an aggressive and malignant form of brain cancer, according to a company news release.

"Through its distinct mechanism of action, preclinical studies suggest that enzastaurin attacks the tumor in multiple ways," Richard Gaynor, vice president of cancer research and global oncology platform leader, said in the release.

The enzastaurin glioblastoma phase 3 trial is a randomized, open label registration study in recurrent glioblastoma, which will compare the efficacy, safety and tolerability of enzastaurin, taken orally, versus CeeNU (lomustine[CCNU]), a common oral chemotherapy used to treat this disease.

The study will enroll 397 patients. Primary endpoints of this study will be progression-free survival and overall survival. Lilly said it 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, increase the natural death of the tumor cells and inhibit tumor-induced blood supply.

Enzastaurin also has been shown to inhibit signaling through the PKC-B and PI3K/AKT pathways, officials said. These pathways have been shown to be activated in a wide variety of cancers.

In addition to glioblastoma, enzastaurin also is 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, officials said.

Enzastaurin has been granted orphan drug designation by the European Agency for the Evaluation of Medicinal Products and by the Food and Drug Administration's Office for Orphan Products Development for the treatment of glioblastoma.

Lilly Oncology, a division of Eli Lilly and Co., has a mission of delivering innovative treatment strategies and essential support programs to physicians and their patients for their battle against cancer.

Lilly is an Indianapolis pharmaceutical company developing a portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.

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