New Data from a Phase 3 Trial Presented
KIRKLAND, QC, June 25 /CNW/ - Pfizer today announced results from a
randomized Phase 3 trial of SUTENT (sunitinib malate) in patients with
advanced pancreatic islet cell tumors, also known as pancreatic neuroendocrine
tumors, which is a different type of cancer than the more common pancreatic
adenocarcinoma. Study findings demonstrated that median progression-free
survival (PFS) was 11.1 months in patients treated with sunitinib compared to
5.5 months in patients treated with placebo. Researchers today presented these
data at the 11th World Congress on Gastrointestinal Cancer in Barcelona,
Spain. The independent Data Monitoring Committee (DMC) recommended halting the
trial earlier this year because sunitinib showed significant benefit and the
study had met its primary endpoint. Full analysis of the data is ongoing.
"In this study, sunitinib demonstrated an impressive improvement in
progression-free survival for patients with pancreatic islet cell tumors,"
said Dr. Hagen Kennecke, MD, MHA, FRCPC, medical oncologist at the British
Columbia Cancer Agency in Vancouver and investigator on this sunitinib Phase 3
study. "This is encouraging news for patients, especially given that there are
limited treatment options for this type of cancer."
Phase 3 Trial Results
This international, Phase 3 trial compared sunitinib to placebo in
patients with progressive, well-differentiated, malignant pancreatic islet
cell tumors who had progressed in the last 12 months. Patients were randomized
to either the sunitinib (n=75) (37.5 mg/day, continuous daily dosing) plus
best supportive care arm or the placebo plus best supportive care arm (n=79).
Results showed that median PFS was 11.1 months in patients treated with
sunitinib compared to 5.5 months in patients treated in the placebo arm
(Hazard ratio 0.397, p(less than)0.001).
Adverse events were similar to those observed in other sunitinib studies.
The most commonly reported grade 3-4 adverse events in the sunitinib arm were
neutropenia (12.3 per cent), hypertension (8.8 per cent), abdominal pain (7
per cent), diarrhea (7 per cent), hypoglycemia (7 per cent) and hand-foot
syndrome (7 per cent).
This trial was initiated based on the results of an earlier Phase 2 trial
of 107 patients published in the Journal of Clinical Oncology (July 2008). A
16.7 percent overall objective response rate (RECIST) and 56.1 percent stable
disease rate (SD (greater than or equal to)6 months) was seen in the 66
patients with advanced pancreatic islet cell tumors treated with sunitinib.
"The observation of substantial improvement in progression free survival
in sunitinib-treated patients was the basis for the independent Data
Monitoring Committee's recommendation to halt accrual to the study early,"
said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and
Medical Affairs for Pfizer's Oncology Business Unit. "This is welcome news as
there is currently no standard of care for patients with pancreatic islet cell
tumors who progress on prior therapy."
About Pancreatic Islet Cell Tumors
In contrast to exocrine pancreatic adenocarcinoma, pancreatic islet cell
tumors are rare, indolent tumors of the endocrine pancreas with an incidence
of two to four people per million annually worldwide. Pancreatic islet cell
tumors include insulinomas, glucagonomas and gastrinomas. Current treatment
options are limited.
About SUTENT (sunitinib malate)
Sunitinib, an oral multi-kinase inhibitor, is currently approved for both
advanced renal cell carcinoma (RCC) (with conditions) and second-line
gastrointestinal stromal tumor (GIST), based on efficacy and safety data from
large, randomized Phase 3 clinical trials. Sunitinib has played an important
role in reshaping the treatment landscape for these two difficult-to-treat
cancers. To date, more than 60,000 patients globally have been treated with
Sunitinib 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.
Sunitinib also inhibits other targets important to tumor growth, including
KIT, FLT3 and RET.
Sunitinib Clinical Research Program
Pfizer is pursuing a broad development program for sunitinib malate and
is studying its role in the potential treatment of various solid tumors.
Healthcare professionals who are interested in learning more about
sunitinib trials that are open for enrollment can visit the SUN program web
site at www.suntrials.com. Patients with questions should contact their
treating physician or obtain additional information through Pfizer, by calling
Medical Information at 1-800-463-6001.
Important SUTENT (sunitinib malate) Safety Information
Women of child bearing age who are (or become) pregnant during therapy
should be informed of the potential for fetal harm while on sunitinib.
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 sunitinib.
The most common adverse reactions in advanced RCC and GIST 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, please visit
About Pfizer Oncology
Pfizer Oncology is committed to the discovery, investigation and
development of innovative treatment options for cancer patients worldwide. Our
robust pipeline consists of 21 biologics and small molecules in clinical
development across four scientific platforms - anti-angiogenesis, signal
transduction, immuno-oncology, and cytotoxic potentiators. Pfizer Oncology has
over 200 clinical trials including robust Phase 3 clinical trial programs in
renal cell carcinoma, prostate cancer, non-small cell lung cancer, advanced
breast cancer, colorectal cancer, and hepatocellular carcinoma.
By working collaboratively with academic institutions, researchers,
governments and licensing partners, Pfizer Oncology strives to transform
treatment by targeting the right drug for the right patient at the right time.
About Pfizer Canada
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and
markets prescription medicines for humans and animals. Pfizer Canada's
commitment to helping Canadians live happier, healthier and longer lives
extends beyond medication. To learn more about Pfizer Canada's More Than
Medication philosophy and programs, visit www.morethanmedication.ca.
DISCLOSURE NOTICE: The information contained in this release is as of
June 25, 2009, Pfizer assumes no obligation to update any 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,
2008 and in its reports on Form 10-Q and Form 8-K.
For further information:
For further information: Morgan Cates, Fleishman-Hillard, (416)
645-8201, Morgan.Cates@fleishman.ca; Safia Généreux-Khali, Pfizer Canada Inc.,
(905) 693-4657, Safia.Genereux-Khali@pfizer.com