Recent R&D Highlights
- 6 Downloads
No early filing for vatalanib
Analysis of progression-free survival in the CONFIRM 11 trial provided mixed results for Novartis and Schering AG. The phase III trial studied the potential progression-free and overall survival benefit of once-daily oral treatment with vatalanib in combination with oxaliplatin/fluorouracil/leucovorin (FOLFOX4) compared to FOLFOX4 + placebo in 1090 chemotherapy-naive patients with metastatic colorectal cancer.
Central radiological review showed that the oral angiogenesis inhibitor vatalanib failed to meet the primary endpoint of progression-free survival (PFS) in first-line colorectal cancer, while investigator analysis showed that the endpoint was met. According to market analyst company Lehman Brothers, this rules out an early filing in the second half of 2005 based on the surrogate endpoint of PFS.
Further analysis of the CONFIRM 1 data, including more detailed evaluations of subpopulations, are ongoing. Based on a review of the CONFIRM 1 results,...
- 1.Schering AG. PTK/ZK CONFIRM 1 phase in study shows positive drug effects in metastatic colorectal cancer-filing now anticipated for early 2007. Media release: 21 Mar 2005Google Scholar
- 2.European Pharmaceuticals. Schering AG -PTK data disappointing but −14% reaction overdone. Lehman Brothers Equity Research (2005)Google Scholar
- 3.Georgia Institute of Technology. Cancer-fighting power promising for synthetic cell-signaling molecule. Media release: 19 Apr 2005Google Scholar
- 4.University of Michigan Health System. Compound from Chinese medicine shows promise in head and neck cancer. Media release: 15 Apr 2005Google Scholar