Topline Results From Phase 3 Trial of Sunitinib With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC)
NEW YORK, Aug. 23 /PRNewswire-FirstCall/ -- Pfizer Inc.
(NYSE:PFE) announced today that the SUN 1087
trial of sunitinib in combination with erlotinib versus erlotinib
demonstrated a statistically significant improvement in
Progression-Free but not in Overall Survival in patients with
previously treated advanced non-small cell lung cancer (NSCLC).
Overall survival was the primary endpoint of the study and
Progression-Free Survival was a secondary endpoint of the study. No
new or unexpected types of adverse events were observed in the
study. Pfizer is continuing to analyze study data, and the results
have been submitted to the European Society for Medical Oncology
(ESMO) Congress, October 8-12, 2010 in Milan, Italy.
(Logo: http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO ) (Logo: http://www.newscom.com/cgi-bin/prnh/20100416/PFIZERLOGO )
"While this trial did not demonstrate a statistically
significant improvement in overall survival for patients treated
with sunitinib plus erlotinib, we believe that the statistically
significant improvement in progression free survival is an
important finding. Over the next few months, we will conduct an
in-depth analysis to gain further insight into these results and
determine whether we can identify one or more subgroups of
non-small cell lung cancer patients for a future trial in either
previously untreated or recurrent disease," said Dr. Mace
Rothenberg, senior vice president of Clinical Development and
Medical Affairs for Pfizer's Oncology Business Unit. "Pfizer is
committed to improving outcomes for patients with lung
cancer."
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 91,000 patients
globally have been treated with sunitinib in the clinical setting
and in trials.
Pfizer Oncology is committed to further developing Sutent in
other tumor types where there is promise and a need for additional
treatment options and continues to evaluate the potential role of
Sutent as a treatment for advanced castration-resistant prostate
cancer and as adjuvant therapy for renal cell carcinoma in Phase 3
trials.
Pfizer Oncology is dedicated to improving outcomes for patients
with lung cancer and has multiple compounds in development to treat
the various forms of the disease, including Phase 3 trials for
crizotinib (PF-02341066), a first-in-class oral ALK (anaplastic
lymphoma kinase) inhibitor, and PF-00299804, an irreversible, oral,
selective pan-HER (human epidermal growth factor receptor)
inhibitor.
About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide. NSCLC accounts
for about 85 percent of lung cancer cases and remains difficult to
treat, particularly in the metastatic setting. Approximately 75
percent of NSCLC patients are diagnosed late with metastatic, or
advanced, disease. For Stage III/IV NSCLC, the five-year survival
rate is only 6 percent.
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
Hepatotoxicity has been observed in clinical trials and
post-marketing experience. This hepatotoxicity may be severe, and
deaths have been reported. It is recommended to monitor liver
function tests before initiation of treatment, during each cycle of
treatment, and as clinically indicated. Sutent should be
interrupted for Grade 3 or 4 drug-related hepatic adverse events
and discontinued if there is no resolution. Sutent should not be
restarted if patients subsequently experience severe changes in
liver function tests or have other signs and symptoms of liver
failure.
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 diarrhea, fatigue, asthenia, nausea,
mucositis/stomatitis, anorexia, vomiting, hypertension, dyspepsia,
abdominal pain, constipation, rash, hand-foot syndrome, skin
discoloration, altered taste 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 August 23, 2010. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or development.
This release contains forward-looking information that involves
substantial risks and uncertainties about (i) certain potential
additional indications for Sutent, including their potential
benefits; (ii) the potential of identifying one or more subgroups
of non-small cell lung cancer patients for whom it would be
appropriate to conduct a future Sutent trial; and (iii) two product
candidates, crizotinib and PF-00299804, including their potential
benefits.. 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 and any drug applications that
may be filed for crizotinib and PF-00299804 as well as the
decisions of regulatory authorities regarding labeling and other
matters that could affect their availability or commercial
potential; 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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Source: Pfizer Inc.
CONTACT: Curtis Allen, +1-212-733-2096, M: +1-347-443-5252,
or
Investors, Suzanne Harnett, +1-212-733-8009, M: +1-646-256-9250,
both of
Pfizer
Web Site: http://www.pfizer.com/
Posted: August 2010
