Novartis this morning revealed that a late stage study of its novel cancer drug, PTK/ZK, in advanced colorectal cancer is unlikely to demonstrate an improvement in overall survival. It is a double-whammy of bad news for the company, which earlier this year revealed similar results from a study of PTK/ZK as a first-line therapy [[17/05/05a]], [[21/03/05a]], and forces Novartis to review regulatory timelines for the compound alongside partner Schering AG.
The news follows a planned interim analysis of the CONFIRM 2 trial by a Data Safety Monitoring Board, which was designed to evaluate the potential overall survival benefit of once daily oral treatment with PTK/ZK in combination with chemotherapy (FOLFOX-4 regimen) as second-line therapy in patients with advanced colorectal cancer. Analysis of the data is ongoing and the companies say the study will continue, with further results anticipated towards the middle of next year, and the interim analysis to be submitted to an upcoming medical meeting. And, during the second half of 2006, comes the full unveiling of data from the aforementioned CONFIRM-1 in first-line colorectal cancer patients.
In light of the findings of CONFIRM 1 and 2, Schering and Novartis will review the regulatory filing strategy and timeline.
- Meanwhile, Novartis says its cash tender offer by Zodnas Acquisition Corp, a wholly owned subsidiary of Novartis AG, for the outstanding public shares of Eon Labs has been successful. Following closure of the offer on June 20, and a final count unveiled yesterday, Zodnas owned 97.7% of Eon stock [[21/07/05f]].