NEW YORK--(BUSINESS WIRE)--Pfizer Inc. announced today that two Phase 3 studies of Sutent®
(sunitinib malate) in advanced breast cancer did not meet their primary
endpoints. The SUN 1064 Phase 3 study of sunitinib in combination with
docetaxel for the first-line treatment of patients with advanced HER-2
negative breast cancer did not show a statistically significant
improvement in progression-free survival compared with docetaxel alone.
In addition, the SUN 1099 Phase 3 study of sunitinib plus capecitabine,
in previously-treated advanced breast cancer patients, did not show a
statistically significant improvement in progression-free survival
compared with capecitabine alone.
“Sunitinib has been thoroughly evaluated in advanced HER-2 negative
breast cancer, and while we are disappointed in the results, these
trials have helped us define the limits and opportunities for the
compound and better understand the complex biology of this disease,”
said Dr. Mace Rothenberg, senior vice president of Clinical Development
and Medical Affairs for Pfizer’s Oncology Business Unit. “Pfizer
Oncology is committed to the rigorous evaluation of investigational
therapies in breast cancer, which despite recent advancements, continues
to claim far too many lives each year.”
There were more adverse events, including serious adverse events, in the
investigational arm than in the comparator arm of each study. A
continuing analysis of efficacy and safety data will be completed and
presented at a medical meeting in the near future.
Sutent is currently approved for both gastrointestinal stromal tumor
(GIST) after disease progression on or intolerance to imatinib mesylate,
and advanced / metastatic renal cell carcinoma (RCC) based on efficacy
and safety data from large, randomized Phase 3 clinical trials. Sutent
has played a significant role in advancing the treatment landscape and
remains standard of care in its approved indications. To date, more than
82,000 patients globally have been treated with sunitinib in the
clinical setting and in trials across multiple tumors.
Pfizer remains committed to the development program for sunitinib and is
continuing to study its potential role in the treatment of other solid
tumors including advanced non-small cell lung cancer, advanced
castration-resistant prostate cancer, advanced hepatocellular carcinoma,
and as adjuvant therapy for renal cell carcinoma, in Phase 3 trials.
Pfizer Oncology is dedicated to further understanding and developing
agents to better match specific patients with treatments and increase
benefits from selected therapies.
About Advanced Breast Cancer
Breast cancer is the most common cancer and the leading cause of
cancer-related death among women globally. Compared to early stage
breast cancer, effective therapy for advanced breast cancer, which
includes inoperable locally advanced and metastatic disease, remains a
clinical challenge in the oncology community. Additional treatment
options are desperately needed to address this continuing unmet medical
need.
About Sutent (®) (sunitinib malate)
Sutent is an oral multi-kinase inhibitor approved for the treatment of
GIST after disease progression on or intolerance to imatinib mesylate
and advanced / metastatic RCC.
Sutent works by blocking multiple molecular targets implicated in the
growth, proliferation and spread of cancer. Two important SUTENT
targets, vascular endothelial growth factor receptor (VEGFR) and
platelet-derived growth factor receptor (PDGFR), are expressed by many
types of solid tumors and are thought to play a crucial role in
angiogenesis, the process by which tumors acquire blood vessels, oxygen
and nutrients needed for growth. Sutent also inhibits other targets
important to tumor growth, including KIT, FLT3 and RET.
Important Sutent (®) (sunitinib malate) Safety Information
Women of childbearing age who are (or become) pregnant during therapy
should be informed of the potential for fetal harm while on Sutent.
Decreases in left ventricular ejection fraction (LVEF) to below the
lower limit of normal (LLN) have been observed. Patients with
concomitant cardiac conditions should be carefully monitored for
clinical signs and symptoms of congestive heart failure.
Patients should be monitored for hypertension and treated as needed with
standard antihypertensive therapy. Complete blood counts (CBCs) with
platelet count and serum chemistries should be performed at the
beginning of each treatment cycle for patients receiving treatment with
Sutent.
The most common adverse reactions in GIST and RCC clinical trials were
fatigue, asthenia, diarrhea, nausea, mucositis/stomatitis, vomiting,
dyspepsia, abdominal pain, constipation, hypertension, rash, hand-foot
syndrome, skin discoloration, altered taste, anorexia and bleeding.
For more information on Sutent and Pfizer Oncology, including full
prescribing information for Sutent (sunitinib malate), please visit www.pfizer.com.
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options to improve the outlook for
cancer patients worldwide. Our strong pipeline, one of the most robust
in the industry, is studied with precise focus on identifying and
translating the best scientific breakthroughs into clinical application
for patients across a wide range of cancers, including breast, lung,
prostate, sarcoma, melanoma, and various hematologic cancers. Pfizer
Oncology has biologics and small molecules in clinical development and
more than 200 clinical trials underway.
By working collaboratively with academic institutions, individual
researchers, cooperative research groups, governments, and licensing
partners, Pfizer Oncology strives to cure or control cancer with
breakthrough medicines, to deliver the right drug for each patient at
the right time.
For more information please visit www.Pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of
March 11, 2010. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward-looking information about certain
potential additional indications for Sutent, including their potential
benefits, that involves substantial risks and uncertainties. Such risks
and uncertainties include, among other things, the uncertainties
inherent in research and development; decisions by regulatory
authorities regarding whether and when to approve any supplemental drug
applications that may be filed for additional indications for Sutent as
well as their decisions regarding labeling and other matters that could
affect the availability or commercial potential of any such additional
indications; and competitive developments.
A further list and description of risks and uncertainties can be
found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
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