- Phase II Results Published in the Journal of Clinical Oncology -
NEW YORK, July 6 /PRNewswire-FirstCall/ -- Results from a Phase II
study - which will be published in the August 10, 2007 issue of the Journal
of Clinical Oncology (JCO) and are now available as an Early Release
Article at http://www.jco.org - demonstrate that ixabepilone, a Bristol-Myers
Squibb Company (NYSE: BMY) investigational compound, has activity in
patients with metastatic breast cancer whose tumors were resistant to three
types of standard chemotherapy (anthracycline, taxane, and capecitabine).
Currently, there are few proven treatment options available to patients
with breast cancer whose disease has rapidly progressed through or whose
disease is not responding to prior treatment with approved chemotherapies.
This study was one of five Phase II ixabepilone studies published in this
issue of JCO, including three additional studies in metastatic breast
cancer and one in non-small cell lung cancer.
"Drug resistance is a major concern in treating patients with advanced
disease," said Renzo Canetta, vice president, Oncology Global Clinical
Research, Bristol-Myers Squibb. "The results of this study are important as
they provide valuable information about this investigational compound and
its potential in patients with advanced breast cancer that is no longer
responding to any of the current U.S. approved chemotherapy treatments."
The 126 patients enrolled in the single-arm Phase II study (CA163081)
had heavily pretreated, advanced metastatic breast cancer, which had
progressed through three prior therapies (anthracycline, taxane and
capecitabine). The primary endpoint was objective response rate, which is
an assessment of the response to treatment as determined by the independent
radiology facility (IRF). Secondary efficacy endpoints included duration of
response, time to response, progression-free survival (PFS), and overall
survival (OS), and with the exception of OS, analyses were based on IRF
data. Response-evaluable patients were defined as patients with measurable
disease, as determined by the IRF, which met the resistance criteria for
anthracyclines, taxanes, and capecitabine. Results of the 113
response-evaluable patients were assessed by the IRF, as well as
independently by investigators at the study site, and showed:
-- Objective response rate was achieved in 11.5% of patients as determined
by the IRF and 18.6% as determined by the investigators.
-- Median duration of response of 5.7 months.
-- Median time to response of 6.1 weeks.
-- Median progression-free survival of 3.1 months.
-- Median overall survival of 8.6 months.
Overall treatment-related non-hematological adverse events greater than
or equal to 20% included: peripheral sensory neuropathy 60% (Grade 3/4:
14%); fatigue/asthenia 50% (Grade 3/4: 14%); myalgia/arthralgia 49% (Grade
3/4: 8%); alopecia 48% (Grade 3/4: 0%); nausea 42% (Grade 3/4: 2%);
stomatitis/mucositis 29% (Grade 3/4: 7%); vomiting 29% (Grade 3/4: 1%);
diarrhea 22% (Grade 3/4: 1%); and musculoskeletal pain 20% (Grade 3/4: 3%).
Treatment-related hematological adverse events greater than or equal to 20%
included: leukopenia 90% (Grade 3/4: 49%); anemia 84% (Grade 3/4: 8%);
neutropenia 79% (Grade 3/4: 54%); and thrombocytopenia 44% (Grade 3/4: 8%).
About Ixabepilone
Ixabepilone is an investigational compound, a semisynthetic analog of
epothilone B, designed to inhibit or prevent the growth or development of
cancer cells. Epothilones are a potential new class of antineoplastic (or
chemotherapy) agents. For information on ixabepilone clinical trials, log
on to http://www.clinicaltrials.gov.
On June 19, 2007 the company announced that the U.S. Food and Drug
Administration has accepted, for filing and granted priority review of,
these data as part of the New Drug Application for ixabepilone. The target
action date is in late October. The proposed indications for ixabepilone
are as a monotherapy to treat patients with metastatic or locally advanced
breast cancer after failure of an anthracycline, a taxane, and capecitabine
and in combination with capecitabine to treat patients with metastatic or
locally advanced breast cancer after failure of an anthracycline and a
taxane. The company also plans to submit these data as part of a
registrational dossier in the European Union, and other countries this
year.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
This press release contains "forward-looking statements" as that term
is defined in the Private Securities Litigation Reform Act of 1995
regarding product development. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them, and could
cause actual outcomes and results to differ materially from current
expectations. No forward-looking statement can be guaranteed. Among other
risks, there can be no guarantee that the application submitted to the FDA
will be approved, that an application will be submitted or approved in any
other country, or, if approved, that the product will be commercially
successful. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Bristol-Myers
Squibb's business, particularly those identified in the cautionary factors
discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the
year ended December 31, 2006 and in our Quarterly Reports on Form 10-Q.
Bristol-Myers Squibb undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
SOURCE Bristol-Myers Squibb
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Related links:
http://www.bms.com
http://www.jco.org http://www.clinicaltrials.gov
CONTACT:
Media, Madeline Malia, Media Communications,
+1-609-252-3347 office, +1-609-651-1323 mobile,
madeline.malia@bms.com, or Jeff Macdonald, Media Communications,
+1-917-371-0940 mobile, jeffrey.macdonald@bms.com, or Investors,
John Elicker, Investor Relations, +1-212-546-3775,
john.elicker@bms.com, all of Bristol-Myers Squibb
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