- First data from the largest trial ever conducted in patients whose
disease has progressed through two widely used and approved chemotherapies
-
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Today, Bristol-Myers Squibb
(NYSE: BMY) reported results from a large randomized Phase III study of the
investigational compound ixabepilone in patients with breast cancer whose
disease had rapidly progressed through, or did not respond to, prior
treatment with chemotherapies (anthracycline and taxane). Results showed
that patients treated with ixabepilone in combination with capecitabine,
experienced a statistically significant improvement in progression-free
survival, the primary endpoint, compared to patients treated with
capecitabine alone. The data were presented at the 43rd Annual Meeting of
the American Society of Clinical Oncology (ASCO) and will be included in
the official "Best of ASCO" program.
"Patients whose disease is no longer responding to currently approved
chemotherapies have few proven treatment options available to them," said
Renzo Canetta, Vice President, Oncology Global Clinical Research, Bristol-
Myers Squibb. "The results of this study provide important information
about this investigational compound especially for patients with metastatic
breast cancer resistant to anthracyclines and taxanes."
In this international open-label Phase III trial, 752 patients with
metastatic breast cancer whose disease had rapidly progressed through at
least two prior therapies (anthracycline and taxane), were randomly
assigned to receive ixabepilone in combination with capecitabine or
capecitabine alone. Study results showed that ixabepilone in combination
with capecitabine:
- Prolonged progression-free survival (5.8 months vs. 4.2 months) - with a
statistically significant 25 percent decrease in the risk of disease
progression (Hazard ratio, 0.75; 95.17% CI = 3.81- 4.50; p< 0.0003), and
- Resulted in an objective response rate in more than twice as many
patients (35% vs. 14%).
Progression-free survival was defined as the time from randomization to
progressive disease or death from any cause, as determined by the
Independent Radiology Review (IRR) committee. Secondary endpoints include
objective response rate (defined as complete and partial antitumor
response), time to response, and duration of overall response, which was
assessed independently by investigators at the study site.
For ixabepilone in combination with capecitabine, most
treatment-related adverse events were consistent with the safety profile of
the individual agents. In addition, capecitabine-associated toxicities
(such as hand-foot syndrome) were not exacerbated by ixabepilone.
Treatment-related non-hematologic Grade 3/4 adverse events reported in
patients treated with ixabepilone in combination with capecitabine
included: peripheral neuropathy (23%), hand-foot syndrome (18%), fatigue
(9%), myalgia (8%), diarrhea (6%), vomiting (4%), nausea (3%), mucositis
(3%), and arthralgia (3%). Treatment-related non-hematologic Grade 3/4
adverse events reported in patients treated with capecitabine alone
included: hand-foot syndrome (17%), diarrhea (9%), fatigue (3%), vomiting
(2%), nausea (2%), mucositis (2%), myalgia (0.3%), arthralgia (0%), and
peripheral neuropathy (0%). Treatment-related hematological Grade 3/4
adverse events in patients treated with ixabepilone in combination with
capecitabine included: leukopenia (57%), anemia (10%), neutropenia (68%),
thrombocytopenia (8%), and febrile neutropenia (4%). Treatment-related
hematological Grade 3/4 adverse events in patients treated with
capecitabine only included: leukopenia (6%), anemia (4%), neutropenia
(11%), thrombocytopenia (4%), and febrile neutropenia (<1%).
About Ixabepilone
Ixabepilone, a semisynthetic analog of epothilone B, is an
investigational compound. Epothilones and their analogs are a potential new
class of antineoplastic, chemotherapy agents. For information on
ixabepilone clinical trials, log on to http://www.clinicaltrials.gov.
About Breast Cancer
The American Cancer Society estimates that more than 180,000 new cases
of breast cancer will be diagnosed in the United States this year, and
almost 41,000 people will die from the disease. Metastatic breast cancer is
the most advanced form of the disease in which the cancer has spread to
other organs in the body.
Unlike cancer that has remained contained in the breast and surrounding
lymph nodes, once the cancer has spread to other organs, the disease cannot
be cured; however, it can be treated.
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.
SOURCE Bristol-Myers Squibb
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Related links:
http://www.bms.com
http://www.clinicaltrials.gov
CONTACT:
Media, Madeline Malia, Communications,
office, +1-609-252-3347, on-site, +1-609-651-1323,
madeline.malia@bms.com, or Tony Plohoros, Communications, office,
+1-212-546-4379, or cell, +1-908-591-2839, tony.plohoros@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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