Study Shows Ixabepilone Demonstrated Clear Activity in Patients with Metastatic Breast Cancer Resistant to Anthracycline, Taxane, and Capecitabine- Phase II Results Published in the Journal of Clinical Oncology -
NEW YORK, July 06, 2007 /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 www.jco.org - demonstrate that ixabepilone, a Bristol-Myers Squibb Company 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%).
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 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.
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Posted: July 2007