PTK/ZK CONFIRM 1 Study Shows Positive Drug Effects in Phase III Study in Metastatic Colorectal Cancer
Mar 21, 2005 - 3:17:38 PM

Novartis Pharma AG and Schering AG announced today that the analysis of progression free survival (PFS) as assessed by central radiology review in the CONFIRM 1 trial with the investigational drug PTK/ZK did not achieve statistical significance. However, a separate pre-planned analysis of progression-free survival as assessed by the investigators achieved statistical significance.

Further analysis of the data including more detailed evaluations of subpopulations are ongoing to fully assess the potential benefit of PTK/ZK. In the study, PTK/ZK was given in combination with the chemotherapy regimen oxaliplatin/5FU/LV, called FOLFOX-4, compared with FOLFOX-4 alone in previously untreated patients.

Based on a review of the CONFIRM 1 results, an independent data monitoring board recommended the Phase III clinical trial program to continue to allow analysis of overall survival endpoints. This is expected in 2nd half of 2006.

Another ongoing phase III trial, CONFIRM 2, compares the PTK/ZK combination regimen to FOLFOX-4 alone in patients with metastatic colorectal cancer who have progressed after irinotecan-based chemotherapy. An interim analysis is planned in mid- 2005 and final overall survival data are expected in mid-2006.

Novartis and Schering now anticipate filing for approval with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) in early 2007. The CONFIRM 1 data will be submitted as a late-breaking abstract to the American Society of Clinical Oncology (ASCO) meeting in Orlando, Florida, May 13-17, 2005.

"The recommendation by the independent monitoring board to continue the Phase III program, and the investigator assessment of progression encourage us to further explore the potential benefit of PTK/ZK in patients suffering from metastatic colorectal cancer and other cancers," said David Epstein, CEO of Specialty Medicines and president of Novartis Oncology. "Novartis and Schering look forward to the complete data analysis of the ongoing Phase III program."

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