Lilly launches Phase III trial of once-daily, targeted oral cancer agent
Eli Lilly plans to run a Phase III clinical trial studying enzastaurin, an investigational, multi-targeted, oral cancer agent. The trial will investigate enzastaurin's potential in treating patients with non-Hodgkin's lymphoma (NHL), the most common cancer of the lymphatic system, which acts to defend the body against disease.
Eli Lilly plans to run a Phase III clinical trial studying enzastaurin, an investigational, multi-targeted, oral cancer agent. The trial will investigate enzastaurin's potential in treating patients with non-Hodgkin's lymphoma (NHL), the most common cancer of the lymphatic system, which acts to defend the body against disease.
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 Richard Gaynor, vice-president, cancer research and global oncology platform leader for Eli Lilly. "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. Early clinical studies of enzastaurin in NHL have been promising and we are excited about continuing our investigation in this trial."
The trial, called PRELUDE (Preventing Relapse in Lymphoma Using Daily Enzastaurin), is a randomised, 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. The company plans to enroll 459 patients across 100 sites worldwide.
Enzastaurin is an oral serine-threonine kinase inhibitor, designed to suppress tumour growth through a distinct mechanism of action. In addition to non-Hodgkin's lymphoma, enzastaurin is also being studied in other tumour types, including glioblastoma, colorectal cancer, non-small cell lung cancer, pancreatic cancer, and mantle cell lymphoma.