Lilly has started a Phase III trial of its oral cancer drug enzastaurin as a maintenance therapy in patients with non-Hodgkin’s lymphoma who have achieved remission after first-line treatment.
This is the second pivotal trial of enzastaurin to be announced in as many months, as Lilly initiated a study in glioblastoma, a form of brain cancer, in March.
Last year, Lilly reported Phase II data showing that the drug achieved a clinical response in up to a quarter of patients with recurrent gliblastoma who had failed more than one prior regimen of chemotherapy. Meanwhile, a Phase II trial in relapsed NHL patients showed that Lilly’s drug kept 22% of patients free of progression for two months, with a quarter of these progression-free for 1.5 to three years. Side effects in both studies were minimal.
Enzastaurin the compound is the first targeted agent from its oncology division to enter late stage clinical development and it is designed to stop the flow of blood to tumours, disrupt tumour growth, and inhibit two of the kinase-based cell pathways that are vital to the survival of tumour cells.
Richard Gaynor, vice president of cancer research at Lilly, said that while there has been significant progrwess made in treating NHL in recent years “our objective with enzastaurin is to develop an agent with the ability to keep NHL patients in remission.”
The Phase III trial, called PRELUDE, will compare enzastaurin to placebo over three years.