Data From a Randomized Phase II Study of Dasatinib or 800 Mg/Day Imatinib- Mesylate (Gleevec(R)) Presented at the 42nd Annual Meeting of the American Society of Clinical Oncology

    ATLANTA, June 3 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company
 (NYSE:   BMY) today presented interim data from a randomized Phase II study
 of the investigational compound dasatinib (140 mg/day) or imatinib (800
 mg/day) in patients with chronic-phase chronic myelogenous leukemia (CML)
 resistant to imatinib (less than or equal to 600 mg/day). The data were
 presented today at the 42nd Annual Meeting of the American Society of
 Clinical Oncology (ASCO).
     This multi-center trial accrued 150 chronic-phase CML patients
 resistant to imatinib. Patients were randomized in a 2:1 ratio to either
 start treatment with dasatinib at 140 mg/day (n=101) or receive increased
 imatinib doses of 800 mg/day (n=49).
     The primary endpoint of the study was major cytogenetic response at 12
 weeks. Major cytogenetic response is defined as complete (no signs of
 Philadelphia chromosome positive [Ph+] cells in the bone marrow) plus
 partial (less than 35% of Ph+ cells in the bone marrow) cytogenetic
 responses. Thirty-five percent (35/101) of patients in the dasatinib arm
 experienced a major cytogenetic response (21% complete). Twenty-nine
 percent (14/49) of patients in the imatinib arm experienced a major
 cytogenetic response (8% complete).
     Crossover to the alternate therapy was permitted in the event of
 disease progression or intolerable toxicity. Six percent (6/101) of
 dasatinib-treated patients and 73% (36/49) of imatinib-treated patients
 crossed over to the opposite treatment arm. At the time of this analysis,
 19 of the patients who crossed over from imatinib to dasatinib were
 evaluable for response; eight of these patients achieved a major
 cytogenetic response (four complete). None of the four evaluable patients
 who crossed over from dasatinib to imatinib achieved a major cytogenetic
 response.
     Important non-hematologic adverse events in the dasatinib arm included
 diarrhea (26%), fluid retention (25%), nausea (21%), bleeding (17%), and
 vomiting (6%). Important non-hematologic adverse events in the imatinib arm
 included fluid retention (43%), nausea (31%), diarrhea (29%), vomiting
 (22%), and bleeding (8%). Grade 3 or 4 cytopenias observed in the dasatinib
 arm included low absolute neutrophil white blood cells (58%), platelets
 (54%), and hemoglobin (9%). Grade 3 or 4 cytopenias observed in the
 imatinib arm included low absolute neutrophil white blood cells (38%),
 platelets (14%), and hemoglobin (8%).
     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 Company
RELATED LINKS
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