BASEL, Switzerland, July 28, 2005 (PRIMEZONE) -- Novartis AG (NYSE:NVS):
- Schering AG and Novartis AG to disclose findings of independent Data Safety Monitoring Board on CONFIRM 2
- PTK/ZK's overall safety profile as well as the activity in high LDH patients found to be consistent with CONFIRM 1
- Filing strategy in metastatic colorectal cancer to be re-evaluated based on analysis of data
- CONFIRM 1 in first-line metastatic colorectal cancer will continue as planned, with overall survival results expected in second half of 2006
Schering AG (NYSE:SHR) (FSE:SCH) and Novartis Pharma AG announced today the decision to disclose data from the CONFIRM 2* trial with PTK/ZK in the second-line treatment of metastatic colorectal cancer. This decision was based on a review by the independent Data Safety Monitoring Board (DSMB) showing a low probability of demonstrating an improvement in overall survival at final analysis. The DSMB assessment was based on a planned interim analysis.
Investigators will be informed of the DSMB's findings to allow for a discussion and decision regarding continuation of treatment. The CONFIRM 2 study is continuing with further results expected in mid-2006. All patients on study will continue to be followed for overall survival.
Progression free survival (PFS), a secondary endpoint of the study, was improved in favor of the PTK/ZK treatment arm with greater effect observed in the pre-defined patient subset with high lactate dehydrogenase (LDH) levels. In a planned subset analysis, patients with high LDH blood levels showed a greater treatment benefit consistent with findings previously seen in CONFIRM 1*. LDH is a standard laboratory parameter measured in cancer patients. Patients with high LDH are considered to have a poor prognosis.
In light of the findings of CONFIRM 1 and 2, Schering and Novartis will review the regulatory filing strategy and timeline. Results of the interim analysis will be submitted for presentation at a major medical meeting. The decision to disclose the CONFIRM 2 data does not impact another ongoing trial, CONFIRM 1, which will continue as planned with final overall survival results expected in the second half of 2006.
* CONFIRM 1 (Colorectal Oral Novel Therapy for the Inhibition of
Angiogenesis and Retarding of Metastases in First-line)
CONFIRM 2 (Colorectal Oral Novel Therapy for the Inhibition of
Angiogenesis and Retarding of Metastases in Second-line)
The Phase III CONFIRM 2 trial 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 metastatic colorectal cancer. Analysis of the data is ongoing.
PTK/ZK is being co-developed by Schering and Novartis.
Additional Information
About PTK/ZK
PTK/ZK, an investigational oral multi-VEGF receptor tyrosine kinases inhibitor, blocks tumor angiogenesis and lymphangiogenesis by inhibiting all known VEGF receptors.
Safety Data
In the CONFIRM 2 trial, the overall side effects that were seen were generally consistent with that of CONFIRM 1. These included an increased incidence of nausea, hypertension, dizziness and thromboembolic events in the PTK/ZK arm of the study.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "low probability," "research is ongoing," "results expected," "will continue," "will be," "will revisit," 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 net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 83,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
-0- Geoffrey M. Cook Nehl Horton Novartis Oncology Novartis Global Media Relations Tel +1 862 778 2675 Tel+41 61 324 5749 Mobile +1 973 652 7927 Mobile +41 79 593 4291 geoffrey.cook@novartis.com nehl.horton@novartis.com http://hugin.info/134323/R/1004090/154404.pdf