Eli Lilly Halts Phase III Trial of DLBCL Drug

Pharmaceutical giant Eli Lilly announced that it is halting the development of the experimental drug enzastaurin after it failed a Phase III trial assessing it as monotherapy for some patients with diffuse large B-cell lymphoma (DLBCL).

Eli Lilly had hoped that the phase III PRELUDE trial would show the efficacy of enzastaurin in the prevention of relapse in patients with DLBCL. Unfortunately, data indicated that the drug failed to show a statistically significant increase compared to placebo in disease-free survival in patients considered to be at high risk relapse following rituximab-based chemotherapy.

On the bright side, safety data was consistent with previous studies of the drug (also known as LY317615 HCl) and no new safety issues came up during the trial.

Fifth Eli Lilly drug trial to fail in past year

The company will present the Phase III data at an upcoming scientific meeting. The failure of enzastaurin amounts to the fifth drug failure for Eli Lilly in the past year.

Said Richard Gaynor, M.D., vice president of product development and medical affairs for Lilly Oncology:

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.

Enzastaurin is believed to work by acting as a serine/threonine kinase inhibitor of the PKC beta and AKT pathways.

Source: Lilly Oncology

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