Eli Lilly and Company (NYSE: LLY) announced today Phase III clinical trial results from enzastaurin’s PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).
The study failed to show a statistically significant increase compared to a placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy. There were no new safety findings, and the safety data were consistent with previously disclosed studies.
“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. “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.”
Lilly plans to present data from this study at an upcoming scientific meeting.
Lilly will stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately $30 million. The company’s previously-issued financial guidance for 2013 remains unchanged.