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Follow-Up Results from Study Comparing SPRYCEL(R) (dasatinib) to Imatinib in First-Line Treatment of Adults with Ph+ CP-CML Demonstrate Improved Response Rates Consistent with 12 Month Data[1]

Princeton, New Jersey and Tokyo (ots/PRNewswire)

Bristol-Myers Squibb Company (http://www.bms.com)  and Otsuka
Pharmaceutical Co., Ltd. today announced 18-month follow-up results
from the Phase 3 DASISION study of SPRYCEL(R) (dasatinib) 100 mg once
daily vs.  imatinib (400 mg daily) in the first-line treatment of
adults with  Philadelphia chromosome-positive (Ph+) chronic phase
chronic myeloid leukemia  (CP-CML). Results at 18 months were
consistent with 12 month data in which  SPRYCEL demonstrated higher
and faster rates of complete cytogenetic response  (CCyR) and major
molecular response* (MMR) compared to imatinib.[1] Results  from the
18-month follow up were presented today at the 52nd Annual Meeting
of the American Society of Hematology.[1]
Safety data from DASISION demonstrated that the most frequently
reported serious adverse reactions with SPRYCEL included pleural
effusion (2%), hemorrhage (2%), congestive heart failure (1%) and
pyrexia ( 1%). Commonly reported adverse events (greater than or
equal to 10%, of all grades) with  SPRYCEL and imatinib included
superficial edema (10% and 36%), pleural  effusion (12% and 0%),
myalgia (22% and 38%), nausea (9% and 21%), vomiting  (5% and 10%),
diarrhea (18% and 19%), fatigue (8% and 11%), headache  (12% and 10%)
and rash (11% and 17%).[1] Overall rates of fluid retention  observed
in the study were 23% with SPRYCEL and 43% with imatinib.[1]
"The follow up results from DASISION are important as they
continue to support the use of SPRYCEL as a first-line treatment
option for newly-diagnosed Ph+ CP-CML patients," said Neil Shah, MD,
PhD, Assistant Professor, Division of Hematology/Oncology, University
of California, San Francisco, and presenter of the study results.
On October 28, 2010, the U.S. Food and Drug Administration (FDA)
approved SPRYCEL 100 mg once daily for newly diagnosed adults with
Ph+ CP-CML based on the twelve-month results from DASISION, which
were published in the New England Journal of Medicine[2] and
presented at the 46th Annual Meeting of  the American Society of
Clinical Oncology earlier this year.[2] The  effectiveness of SPRYCEL
is based on cytogenetic and major molecular  response rates. The
DASISION trial is ongoing and further data is required  to determine
long-term outcome.
Detailed Study Results From 18-Month Follow-Up
In the DASISION study, 78% of patients treated with SPRYCEL(R)
(dasatinib) vs. 70% of patients treated with imatinib achieved
confirmed CCyR  (two consecutive assessments of CCyR at least 28 days
apart) by 18 months (p=0.0366).[1] MMR at any time was 57% for
patients treated with SPRYCEL vs. 41% for patients treated with
imatinib (p=0.0002).[1] Transformation to accelerated or blast phase
occurred in 6 patients receiving SPRYCEL and 9 patients receiving
imatinib.[1]
Pleural effusion (all grades) was reported in 12% of those
treated with SPRYCEL, and in none treated with imatinib; Grade 3
pleural effusion was reported in <1% of patients receiving
SPRYCEL.[1] Thrombocytopenia occurred  in 19% of those treated with
SPRYCEL and 10% of those treated with imatinib. [1] Neutropenia
occurred in 22% of those treated with SPRYCEL and 20% of  those
treated with imatinib.[1]
About the DASISION Study
DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve
CP-CML Patients) is an open-label, randomized, Phase 3 international
trial of SPRYCEL 100 mg taken once daily vs. imatinib 400 mg taken
once daily, in the treatment of newly diagnosed chronic phase Ph+
CML. [2] The study enrolled  519 patients; 259 patients were
randomized to receive SPRYCEL and 260  patients were randomized to
receive imatinib.[2] The primary study endpoint  was the rate of
confirmed CCyR by 12 months.[2] Secondary endpoints included  time-to
confirmed CCyR, MMR rate and time-to MMR. [2]
About SPRYCEL
Discovered and developed by Bristol-Myers Squibb, SPRYCEL
initially received accelerated FDA approval in June 2006 as a
treatment for adults for all phases of Ph+ CP-CML (chronic,
accelerated, or myeloid or lymphoid blast phase) with resistance or
intolerance to prior therapy including imatinib. Full approval was
granted in May 2009. On October 28, 2010, the FDA approved SPRYCEL
100 mg once daily in newly diagnosed adults with Ph+ CP-CML. SPRYCEL
is also approved for the treatment of adults with Ph+ acute
lymphoblastic leukemia with resistance or intolerance to prior
therapy.
About Chronic Myeloid Leukemia
CML is a slow-growing type of leukemia in which the body produces
an uncontrolled number of abnormal white blood cells.[3] About 24,800
people are living with the disease in the United States.[4] It is
estimated that 4,870 new cases will be diagnosed in 2010.[7] CML
occurs when pieces of two  different chromosomes break off and attach
to each other.[5] The Philadelphia chromosome contains an abnormal
gene called the bcr-abl gene.[8] This gene produces the BCR-ABL
protein, which causes the body to make too many abnormal white blood
cells.[8] There is no known cause for the genetic change that causes
CML.[6]
About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.
Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are
collaborative partners in the commercialisation of SPRYCEL in the
United States, and in Japan. SPRYCEL was discovered and developed by
Bristol-Myers Squibb.
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines that
help patients prevail against serious diseases. Around the world, our
medicines are helping millions of patients in their fight against
such diseases as cancer, heart disease, HIV/AIDS, psychiatric
disorders, rheumatoid arthritis, chronic hepatitis B virus infection
and diabetes.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global
healthcare company with the corporate philosophy: 'Otsuka-people
creating new products for better health worldwide.' Otsuka
researches, develops, manufactures and markets innovative and
original products, with a focus on pharmaceutical products for the
treatment of diseases and consumer products for the maintenance of
everyday health.
References
[*] Major molecular response (MMR) is defined as a BCR-ABL
transcript level of less than or equal to (3 log reduction) as
measured by real-time  quantitative polymerase chain reaction
(RQ-PCR) of peripheral blood.
[1] Shah, NP., Kantarjian, H., Hochhaus, A., et. al. Dasatinib
versus Imatinib in Patients with Newly Diagnosed Chronic Myeloid
Leukemia in Chronic Phase (CML-CP) in the DASISION Trial: 18-Month
Follow-up. ASH 2010 Abstract Oral L-S Draft.
[2] "SPRYCELÒ (dasatinib) Demonstrates Superior Confirmed
Complete Cytogenetic Response Rates Compared to GleevecÒ[2] in Study
of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in
Chronic Phase," Bristol-Myers Squibb Press Release, June 5, 2010.
[3] National Cancer Institute Web site. Dictionary of cancer
terms. "chronic myeloid leukemia." Available at: http://www.cancer.go
v/dictionary/?searchTxt=chronic+myeloid+leukemia&sgroup=Starts+with&l
ang=  Accessed on November 4, 2010.
[4] The Leukemia & Lymphoma Society Web site. "Chronic
Myelogenous Leukemia". Available at:
http://www.leukemia-lymphoma.org/all_page?item_id=8501. Accessed on
November 4, 2010.
[5] American Cancer Society Web site. Do we know what causes
chronic myeloid leukemia? Available at: http://www.cancer.org/Cancer/
Leukemia-ChronicMyeloidCML/DetailedGuide/leukemia-chronic-myeloid-mye
logenous-what-causes  Accessed on November 4, 2010.
[6] American Cancer Society Web site. "Can Chronic Myeloid
Leukemia Be Prevented?" Available at: http://nccu.cancer.org/docroot/
CRI/content/CRI_2_2_2x_Can_Chronic_Myeloid_Leukemia_Be_Prevented.asp?
rnav=cri  Accessed on November 4, 2010.
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Contact:

CONTACT: Contacts: Bristol-Myers Squibb, Media: Sarah
Koenig,Bristol-Myers Squibb, +1-609-252-4145, sarah.koenig@bms.com;
European Media Contact: Elzbieta Zawislak, Bristol-Myers Squibb,
+33-615-523580, elzbieta.zawislak@bms.com;Otsuka, US: David Caruba,
Otsuka America Pharmaceutical Inc., +1-609-524-6798,
david.caruba@otsuka-us.com; Japan: Masamitsu Kitada, Otsuka
Pharmaceutical Co., Ltd., kitadams@otsuka.jp

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