PTK/ZK CONFIRM 1 Study Shows Positive Drug Effects in Phase III Study in Metastatic Colorectal Cancer
Mar 21, 2005, 15:18, Reviewed by: Dr.
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Pre-planned analysis of progression-free survival as assessed by investigators achieved statistical significance while analysis of primary endpoint of progression-free survival assessed by central review did not achieve statistical significance. Independent data monitoring board recommends CONFIRM 1 trial to continue to allow analysis of overall survival (Second Primary Endpoint)
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By Novartis,
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." 
- Novartis
http://www.novartis.com/
About PTK/ZK
PTK/ZK, an investigational oral multi-VEGF receptor tyrosine kinase inhibitor, blocks tumor angiogenesis and lymphangiogenesis by inhibiting all known VEGF receptors. Targeting all the VEGF receptors rather than a single VEGF type may provide a new approach for inhibiting tumor growth and spread.
Safety Data
In the CONFIRM 1 trial, the side effect profile was generally consistent with effects of anti-angiogenic therapy including hypertension and thrombo-embolic events. A review of the safety data will be submitted for presentation at ASCO. To date, in Phase I/II trials, PTK/ZK treatment has been generally well tolerated in more than 500 patients with up to 24 months of uninterrupted treatment. The most frequently reported adverse events were nausea, fatigue, vomiting and dizziness and the majority of these were mild to moderate. PTK/ZK should not be administered to women who are pregnant or lactating or to anyone not practicing adequate contraception.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "progression-free survival," "are ongoing," "are anticipated," "could be used," "are expected," "will reassess," "further assess the potential benefit," "will explore," "look forward," "are awaiting," "will continue," "has the potential," or similar expressions, or by discussions regarding the potential that PTK/ZK will be approved for marketing, or regarding any potential revenues from PTK/ZK. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with PTK/ZK to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that PTK/ZK will be approved for sale in any market. In particular, management's expectations regarding commercialization of PTK/ZK could be affected by, among other things, uncertainties relating to clinical trials; new clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; as well as other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and a net income of USD 5.8 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81 400 people and operate in over 140 countries around the world.
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