Lilly's enzastaurin slows progression of lymphoma, study says

By Angela McDaniels

Seattle, Dec. 12 - Eli Lilly & Co. said data from a phase 2 study offers evidence that enzastaurin slowed the progression of diffuse large B-cell non-Hodgkin's lymphoma in several patients pretreated with chemotherapy.

The phase 2, multi-center clinical trial evaluated relapsed patients previously treated with a median of two other therapies. Of 55 patients, 22% treated with enzastaurin were free of disease progression for two months. A quarter of those patients remained progression free with continued responses of one and a half years to more than three years in duration, the company said.

Overall, enzastaurin was well tolerated in this patient population.

"The use of enzastaurin in relapsed diffuse large B-cell lymphoma is important for two reasons," lead investigator Margaret A. Shipp of the Dana-Farber/Harvard Cancer Center said in a company news release.

"One, it represents a rational inhibitor of an identified target and, two, several patients with aggressive chemo-insensitive disease have had prolonged responses to this single, oral agent."

The data was presented Monday at the American Society of Hematology's 47th annual meeting in Atlanta.

In addition, preclinical data indicate that enzastaurin may have additional effects on cutting off the tumor's blood supply, increasing the natural death of tumor cells and reducing the cell's ability to reproduce.

Enzastaurin inhibits the PKC-Beta and AKT/P13 pathways. This PKC-Beta protein stimulates cell growth. An overexpression of PKC-Beta has been linked to poor outcomes for patients with large B-cell non-Hodgkin's lymphoma, the company said, and Enzastaurin was created to target PKC-Beta.

Lilly will soon begin enrolling patients in a phase 3 registration trial of enzastaurin to determine if it can delay relapse in patients who have already undergone treatment and have achieved remission following the standard of care.

In addition to non-Hodgkin's lymphoma and glioblastoma, enzastaurin will be evaluated in other tumor areas such as colon cancer, non-small cell lung cancer and mantle cell lymphoma.

Non-Hodgkin's lymphoma is the most common cancer of the lymphatic system, the company said. Of the nearly 500,000 Americans with lymphoma, 332,000 have this form.

Eli Lilly is a pharmaceutical company based in Indianapolis.

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