Bristol-Myers Squibb GmbH & Co.KG aA

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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ots Originaltext: Bristol-Myers Squibb GmbH & Co.KG aA
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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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