ORLANDO, Florida, May 16 / PRNewswire / - There have been four types of tumors at ASCO
The investigational new drug from Pfizer Inc, SUTENT/SU11248 (sunitinib malate) has doubled the survival rate ...
and reduced the growth and spread of tumors in a Phase III study in patients with gastrointestinal stromal tumors resistant to Gleevec (GIST). The promising results achieved in Phase II analysis were also observed in other tumor types, including metastatic carcinoma of the renal cell carcinoma (mRCC), metastatic breast cancer and neuroendocrine tumors, according to new data presented this week at the annual meeting American Society of Clinical Oncology (ASCO).
"These data are consistent with the activity of sunitinib against difficult to treat tumors, particularly GIST and mRCC, both potentially dangerous and very few treatment options if there is any other," said Dr. John LaMattina, director general global research and development at Pfizer.
Sutent is an inhibitor of tyrosine kinase highly selective eliminates tumors of blood and nutrients needed for growth and simultaneously kills cancer cells that make tumors grow.
GIST Studies
- Results of a double-blind Phase III study in more
300 patients resistant or tolerant of treatment care
standard based on Gleevec (R) (imatinib mesylate) showed that
Sunitinib significantly improved time to tumor progression
(6.3 months for sunitinib versus 1.5 months for controls)
reducing the risk of death by about 50% compared
with placebo.
- Moreover, the long-term monitoring data of the study in Phase
III showed that Sutent extended overall survival rate
almost 20 months for patients who experienced a breakthrough
carcinogen, this despite undergoing treatment with other
therapies. In addition, the median time to tumor progression in this study
was 7.8 months for all patients, with some subtypes
specific benefit patients even more than expected
by Gleevec.
"These findings underscore the concept that molecular therapies with multiple targets than resistance to other drug targets in cancer cases," said Dr. George Demetri of the Dana-Farber Cancer Institute at Harvard University in Boston, principal trial investigator sunitinib for GIST. "We think that SUTENT may have a wide spectrum of activity for the various forms of cancer beyond what we observed in patients with GIST. We believe that SUTENT is an important development as cancer therapy. "
Carcinoma metastatic renal cell
Data from two Phase II clinical trials have shown that patients with resistant renal cell, or kidney tumors, who received Sutent experienced higher response rates and delayed tumor progression.
- The results of a study performed in 63 patients demonstrated
that 40% of patients responded positively to
SUTENT based treatment, as assessed by the criterion
standard response. Tumors did not progress over a period of
more than three in 28% of patients, indicating that 68% of
patients could benefit from sunitinib treatment. Furthermore,
median time to tumor progression for patients in this study was
8.7 months, and the average survival was 16.4 months.
- A second Phase II study performed by 106 patients
showed objective response rate of 39% in patients treated
SUTENT. Furthermore, 23% of patients experienced
tumor stabilization. Taken together, 62% of patients
beneficiaries obtained based on sunitinib treatment.
"The results of this study indicate that sunitinib has antitumor activity in cases of metastatic carcinoma of the renal cells as second line, forming the basis for launching a large-scale Phase III to determine the potential benefits of SUTENT in the first phase of the disease, "said lead study investigator Dr. Robert Motzer, an attending physician at Memorial Sloan-Kettering Cancer Center. "These studies have also helped achieve a significant amount of data indicating that agents are to achieve the simultaneous improvement of various receptors that serve to provide new options for patients who have problems with kidney cells," he added.
Preliminary data on breast cancer and neuroendocrine
- Preliminary results of a Phase II study of sunitinib in
patients with inoperable neuroendocrine tumors have been presented
Sunday 15 May.
- Preliminary results from a Phase II which
evaluated the results of sunitinib in the treatment of patients
received other standard therapies for cancer treatment
Breast presented on Monday 16 May.
The most common side effects of Sutent have been classified as severe, or reversible until the end of treatment. The most severe side effects were fatigue, myelosuppression (low white blood cells) and gastrointestinal complaints (diarrhea, nausea and vomiting). The full profile of sunitinib side effects not yet known.
SUTENT has not been approved by the Food and Drug Administration U.S. or other global regulatory agencies.
About Pfizer Oncology
Pfizer Oncology is committed to scientific progress and the fight against cancer, presenting new medicines that are used to address the medical needs of many patients with cancer. The investigational oncology is a priority for Pfizer, and invests 12% of assets invstigación and development company in the discovery and development of innovative therapies to treat breast cancer, colorectal and other cancers.
Please note: The information contained in this release are dated May 14, 2005. Pfizer assumes no obligation to update any "forward-looking statements contained in this document as a result of the implementation of new information or future events or developments.
This release will contain information subject to risks and uncertainties regarding a product under development that is potentially effective as a product, and shall involve risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainty of success in research and development activities, decisions of regulatory authorities on how and when to approve new drug applications for product candidates from research as well decisions regarding labeling and other matters that could affect trade alpotencial this product candidate, in addition to its development.
A list and description of risks and uncertainties in the Annual Report on Form 10-K for the fiscal year ended December 31, 2004, in addition to its reports on Form 10-Q and Form 8-K.
