On May 10, 2013 Eli Lilly reported 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) (Press release Eli Lilly, MAY 10, 2013, View Source [SID:1234501030]). The study failed to show a statistically significant increase compared to 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.
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"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.
About the Study
Patients enrolled in PRELUDE had histologically confirmed DLBCL with an International Prognostic Index (IPI) score of three to five at diagnosis. The IPI is a simple, clinical tool that is used to predict survival outcomes for patients with DLBCL. Patients enrolled also achieved a complete response or complete response-unconfirmed to cyclophosphamide, doxorubicin, vincristine, and prednisone, plus rituximab (R-CHOP) therapy. Patients were randomized in a 2:1 fashion to receive enzastaurin or placebo.
Treatment continued until patients developed progression of disease, unacceptable adverse events, or completed three years of therapy.