Lilly's Enzastaurin Disappoints in Phase III Trial - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Lilly's Enzastaurin Disappoints in Phase III Trial



Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). Clinical data showed that treatment with enzastaurin did not significantly increase disease-free survival compared to placebo. Safety data were consistent with previous studies, with no new safety findings. Lilly will present data from this study at an upcoming scientific meeting.

Lilly has decided to stop development of enzastaurin. The company's investigational oral small molecule is a serine/threonine kinase inhibitor of the PKC beta and AKT pathways. Termination will result in a second-quarter charge to the company's R&D expenses of approximately $30 million. Lilly's previously-issued financial guidance for 2013 remains unchanged.

"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, in the company's press release. "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."

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here