The planned interim analysis of an ongoing trial evaluating PTK/ZK suggests the drug does not increase overall survival when used as a second-line therapy in advanced colorectal cancer. The companies said their filing strategy would have to be re-evaluated.
Shares in Germany’s Schering AG dropped by over 2%, while the Swiss drug maker saw a less drastic decrease of 0.3%.
Analysts had hailed PTK/ZK as a potential blockbuster capable of competing with ImClone’s Erbitux and the Roche/Genentech drug Avastin. The recent revelations have, however, prompted analysts to slash their profit forecasts for the drug.
The delay will be particularly hard felt by Schering since the company has suffered several previous setbacks to its research pipeline over recent years.
The study of PTK/ZK as a first line treatment for metastatic colorectal cancer will continue as planned, with overall survival results expected in the second half of 2006. Continued treatment of patients using the drug as a second-line defense is currently under discussion.
“Based on these findings, we will review the development strategy for PTK/ZK and continue to explore its potential,” said Marc Rubin, member of the executive board of Schering AG, responsible for development and oncology.