Meta-Analysis Results Presented at ASCO Show Statistically Significant Delay in Time to Disease Progression for Advanced Prostat
06 Juin 2004 - 12:30AM
PR Newswire (US)
Meta-Analysis Results Presented at ASCO Show Statistically
Significant Delay in Time to Disease Progression for Advanced
Prostate Cancer Patients Taking Atrasentan -- Studies of
Investigational Anti-Cancer Drug Currently Ongoing -- NEW ORLEANS,
June 5 /PRNewswire-FirstCall/ -- An analysis examining pooled data
from two clinical studies of atrasentan shows a statistically
significant (p=0.013) delay in time to disease progression in men
with metastatic, hormone refractory prostate cancer who took the
drug versus those who took placebo. Analyzed separately these
studies trended toward atrasentan, but did not show statistical
significance. The data were presented today by Michael A. Carducci,
M.D., Johns Hopkins Kimmel Cancer Center at the American Society of
Clinical Oncology (ASCO) annual meeting. Atrasentan is an oral,
non-hormonal, non-chemotherapy investigational anti-cancer agent.
Prostate cancer is the most common solid tumor in American men. An
estimated 230,000 men will be diagnosed with prostate cancer and
29,000 will die from the disease this year in the United States.
"These meta-analysis results are encouraging and show that
atrasentan holds promise for the treatment of metastatic,
hormone-refractory prostate cancer," said Perry Nisen, M.D. Ph.D.,
divisional vice president, Global Oncology Development at Abbott
Laboratories. Meta-Analysis of M96-594 & M00-211 To examine the
overall treatment effect of atrasentan in men with metastatic,
hormone refractory prostate cancer, Abbott conducted a simple
retrospective pooling of its two large, randomized, well-controlled
clinical trials (M96-594 & M00-211) with a total patient
population of 1097. Results pooled from two different atrasentan
doses (2.5mg and 10mg) demonstrate a statistically significant
(p=0.013) delay in time to disease progression in the intent to
treat analysis for men taking atrasentan vs. placebo. The two
individual studies pooled for the meta-analysis tested the same
patient population with similar baseline demographics, used the
same endpoint of time to disease progression (radiographic
progression was more explicitly defined in the M00-211 protocol)
and were placebo-controlled and double blind. Abbott has conducted
statistical tests for heterogeneity of the studies and on the
overall treatment effect to support the rigor of the meta-analysis.
Atrasentan (10mg) was generally well tolerated in both studies
among all patients. The most common associated adverse events for
atrasentan vs. placebo were, headache (21 percent vs. 13 percent),
peripheral edema (39 percent vs. 13 percent), and rhinitis (34 vs.
14 percent) respectively. "A meta-analysis is a useful tool in
assessing modest but nevertheless clinically important treatment
effects. The combined results from these studies are very
encouraging and suggest atrasentan may be an exciting novel
treatment option which targets the endothelin axis," said Professor
David Dearnaley, MD, FRCP, Institute of Cancer Research/Royal
Marsden Hospital. "These are the first trials to explore the
benefit of the endothelin-A receptor antagonists in hormone
refractory prostate cancer and give rise to optimism than an
entirely different class of agents may be valuable after failure of
conventional treatments." About Atrasentan Atrasentan, an oral,
once-daily, non-hormonal, non-chemotherapy, anti-cancer agent,
belongs to a class of compounds known as selective endothelin-A
receptor antagonists, or SERAs. SERAs antagonize the effect of
endothelin (ET-1), one of the proteins thought to be involved in
the stimulation of the spread of cancer cells. Atrasentan is the
result of Abbott's discovery effort in oncology. Atrasentan has
been studied in Phase II and Phase III clinical trials in patients
with metastatic, hormone refractory prostate cancer. It is
currently in its second Phase III pivotal trial (M00-244) involving
men with prostate cancer that has not spread (non-metastatic). It
is also being evaluated in a Phase II trial (M01-366) in men with
rising prostate-specific antigen (PSA) following prostate cancer
surgery. Additionally, Abbott continues to support the
investigation of atrasentan in other cancers including kidney,
ovarian, brain, and non-small-cell lung cancers. Atrasentan has
been granted fast track review status from the U.S. Food and Drug
Administration (FDA). About Abbott Laboratories Abbott Laboratories
is committed to the discovery and development of innovative
treatments to help patients in the fight against cancer. Abbott's
oncology research is focused on developing targeted, less toxic
therapies than are currently available. The company has several
different classes of compounds in various stages of clinical
development. These approaches address multiple phases of cancer
progression, including angiogenesis (new blood vessel formation),
signal transduction and programmed cell death (apoptosis). Abbott's
Oncology Franchise extends beyond pharmaceutical research to
supportive care products and diagnostics. Abbott currently
manufactures products for pain management, including
patient-controlled analgesia pumps, and markets tests for detection
of cancer, including a PSA test. Abbott's innovative genomic tests
include Vysis(R) UroVysion, for monitoring the recurrence of
bladder cancer, and PathVysion(R), for detecting the HER-2 gene,
which predicts potential treatment benefit in women with breast
cancer. Abbott also markets nutritional products designed to meet
the unique dietary needs of cancer patients. Abbott Laboratories is
a global, broad-based health care company devoted to the discovery,
development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics.
The company employs more than 55,000 people and markets its
products in more than 130 countries. DATASOURCE: Abbott
Laboratories CONTACT: U.S. Media, Catherine Bryan, +1-847-938-8551,
or Cell, +1-312-209-0250, Media Outside the U.S., Brian Kyhos,
+1-847-936-7988, or Financial Community, John Thomas,
+1-847-938-2655, all of Abbott Laboratories Web site:
http://www.abbott.com/ Company News On-Call:
http://www.prnewswire.com/comp/110328.html
Copyright