Lilly's enzastaurin enters Ph III NHL trials

US drug major Eli Lilly says it has initiated a Phase III clinical trial assessing the anticancer agent enzastaurin, an oral serine-threonine kinase inhibitor designed to suppress tumor growth, as a potential treatment for non-Hodgkin's lymphoma. Specifically, the drug will be used as a maintenance therapy in patients suffering diffuse large B cell lymphoma who have achieved remission following first-line therapy.

The program, which will seek to enroll 459 patients at 100 sites worldwide, will compare the drug's efficacy, safety and tolerability in the treatment of this condition with placebo, over a three year period. The trial's primary endpoint is defined as overall disease-free survival, with additional assessment of related biomarkers also planned to allow the correlation of patient response to the drug.

Phase II data from trials of the agent as a treatment for glioblastoma and non-Hodgkin's lymphoma, which were presented at last year's meetings of the American Society of Clinical Oncology and the American Society of Hematology, respectively, suggested that the drug may be of benefit in these indications. The company added that it had initiated a Phase III study of the compound in the treatment of glioblastoma in the first quarter of the year (Marketletter March 20), noting that the drug is also being studied as a treatment for other types of cancer.