Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). Clinical data showed that treatment with enzastaurin did not significantly increase disease-free survival compared to placebo. Safety data were consistent with previous studies, with no new safety findings. Lilly will present data from this study at an upcoming scientific meeting.
Lilly has decided to stop development of enzastaurin. The company's investigational oral small molecule is a serine/threonine kinase inhibitor of the PKC beta and AKT pathways. Termination will result in a second-quarter charge to the company's R&D expenses of approximately $30 million. Lilly's previously-issued financial guidance for 2013 remains unchanged.
"We are disappointed in the results that we're announcing today," said Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology, in the company's press release. "However, our oncology pipeline is still one of the most robust across the industry containing more than 20 molecules, including two Phase III molecules in five different tumor types."