December 22, 2006
Lilly halts enrollment in brain-cancer trial
Following the report of an external monitoring committee, Eli Lilly decided to halt enrollment in a late-stage clinical trial for cancer agent enzastaurin. Just two weeks ago, the company had told investors and analysts it was forging ahead with a phase III trial studying the compound in recurrent glioblastoma, an aggressive form of brain cancer. The trial was stopped after the committee’s report suggested enzastaurin would not improve progression-free survival over existing chemotherapy. Other enzastaurin trials are unaffected by the report, however. Lilly is enrolling patients in a Phase III trial testing enzastaurin for use as a maintenance therapy for the treatment of non-Hodgkin’s lymphoma. And several phase II studies continue across a variety of more common tumor types, including breast, colon, lung, ovarian and prostate cancers. Although the report was a minor setback, analysts called it the latest sign of softness in Lilly’s pipeline. In August, the FDA failed to approve diabetic retinopathy drug Arxxant (ruboxistaurin), subsequently asking for an additional phase III clinical trial which could take up to five years to complete. Lilly is appealing that decision. And last year Lilly said it was delaying development of anti-clotting drug called Prasugrel. Analysts had expected it to be on the market in 2007. Lilly said it expects to submit Prasugrel for FDA approval late next year.