Late-stage trial fail for Lilly’s lymphoma drug
Eli Lilly & Co has announced that it will be ending phase 3 clinical trials of its large B-cell lymphoma drug, enzastaurin, after it failed to meet its primary endpoint.
The PRELUDE study was exploring the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). The primary endpoint was for the drug to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy – this endpoint was not met, but the safety data remained consistent with previously disclosed studies.
“We are disappointed in the results that we’re announcing today. 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.”
Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology.
Lilly is going to stop development of enzastaurin, which is expected to result in a second-quarter charge to R&D expense of approximately US $30 million.
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