Lilly launches pivotal trial for targeted oral cancer agent

Enzastaurin is an oral serine-threonine kinase inhibitor that is designed to suppress tumor growth through a distinct mechanism of action.

In the phase III clinical trial, enzastaurin will be evaluated as a maintenance therapy in patients with diffuse large B-cell lymphoma who have achieved remission following first-line therapy.

Diffuse large B-cell lymphoma (DLBCL) is the most common form of NHL and the goal of maintenance therapy is to prevent relapse. In March, Lilly announced the first phase III trial for enzastaurin in glioblastoma, a common type of brain cancer.

Phase II trial results for enzastaurin in glioblastoma and non-Hodgkin's lymphoma were presented at last year's American Society of Clinical Oncology and American Society of Hematology annual meetings, respectively.

“The incidence of non-Hodgkin's lymphoma has been increasing rapidly over the past 25 years,” said Dr Richard Gaynor, vice president, cancer research and global oncology platform leader for Eli Lilly and Company.

“In recent years, there has been much progress in developing therapies that get more patients into remission. However, our objective with enzastaurin is to develop an agent with the ability to keep NHL patients in remission.”

The enzastaurin non-Hodgkin's lymphoma phase III trial (PRELUDE – Preventing Relapse in Lymphoma Using Daily Enzastaurin) is a randomized, placebo controlled study of patients in their first remission from DLBCL. The study will compare the efficacy, safety and tolerability of enzastaurin, taken orally for up to three years, versus placebo.

A steering committee will oversee this study, which is planned to enroll 459 patients across 100 sites worldwide.