Data From a Randomized Phase II Study of Dasatinib or 800 Mg/Day Imatinib- Mesylate (Gleevec(R))

[Guest guest]

Hello All,

I watched this data being presented to the FDA Advisory Panel on Friday via

a live webcast and it was quite impressive. This is very good news for any

of us who might need a plan B! I couldn't help but " flashing back " while

this was being presented to when I had been diagnosed in November 2000. In

December 2000 the ASH (American Society of Hematology) conference was

absolutely brimming with the great news of Gleevec. As a newly dxed patient

that gave me great hope. I knew I was going to go on Interferon anyway, but

it was nice to know that there was a plan B. However, I have to tell you

that everyone on the advisory panel stated that the results were so good for

this drug that they strongly urged the sponsor (BMS) to do " Front Line "

trials for this drug. When doctors were asked about the side effects,

including pleural effusion, all the doctors said, they would much rather

treat those side effects than think about the alternatives.

Cheers to all of us!

Cheryl-Anne

Data From a Randomized Phase II Study of Dasatinib or 800 Mg/Day Imatinib-

Mesylate (Gleevec®) Presented at the 42nd Annual Meeting of the American

Society of Clinical Oncology

Saturday June 3, 4:00 pm ET

ATLANTA, June 3 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company

(NYSE: <http://finance./q?s=bmy & d=t> BMY -

<http://finance./q/h?s=bmy> News) 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%).

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