Healthcare Industry News: chronic myelogenous leukemia
News Release - June 3, 2006
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 (HSMN NewsFeed) -- 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).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%).
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Source: Bristol-Myers Squibb
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