Pharmaceutical Business review

Eli Lilly drug reduces brain tumors in phase II trial

The preliminary data show patients with recurrent glioblastoma multiforme, a form of primary brain cancer, experienced a significant tumor response rate with minimal side effects when treated with enzastaurin, an oral, targeted agent under development at Eli Lilly.

Tumor shrinkage was evident in 20-25% of the 92 treatment-resistant cancer sufferers participating. Overall, enzastaurin was well tolerated with minimal side effects exhibited. The most common side effect was thrombocytopenia, which is a low platelet count.

Patients’ treatment consisted of an oral fixed dose of 500mg of enzastaurin, administered daily. Treatment was allowed to continue indefinitely depending upon the patient’s response to the drug. The final results from the phase II study are expected by 2006 and Lilly is currently designing the protocol for a phase III study of enzastaurin in recurrent glioblastoma.

Enzastaurin acts by stopping the flow of blood to the tumor resulting in disruption of tumor growth and eventual shrinkage. “Enzastaurin’s mode of action is unique because it impacts tumor cells in multiple ways, while other targeted agents act on one pathway,” said Richard Gaynor, vice president of cancer research and clinical investigation at Lilly.