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

MONTREAL, Jan. 17 /CNW Telbec/ - The investigational use of SPRYCEL® (dasatinib) in newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) Chronic Phase Chronic Myelogenous Leukemia (CP-CML) was the subject of an oral presentation at the 52nd Annual Meeting of the American Society of Hematology (ASH). The 18-month findings from the Phase III DASISION study showed that previously untreated patients had superior complete cytogenetic response and major molecular response when treated with once daily SPRYCEL compared with once daily imatinib, demonstrating that patients may benefit from earlier use of the treatment.

"These results confirm our knowledge of the clinical effectiveness of dasatinib and the promise of this therapy to be effective as a first-line regimen," said Dr. Jeff Lipton, medical oncologist and Professor of Medicine at the University of Toronto.  "The deep and rapid responses observed in this study when compared to historical controls suggest that dasatinib will have an important role in the future management of newly diagnosed CP-CML patients."

More than 75 per cent of patients who were treated SPRYCEL responded to the therapy with rapid and complete cytogenetic responses (defined by the absence of Ph+ cells) with a favourable toxicity profile. The 18-month results are consistent with the 12 month data from the DASISION trial and compare favourably to those patients who were treated with the current standard initial treatment for CML, Gleevec® (imatinib).

"As both a CML patient and advocate of the right drug for the right patient at the right time, this is welcome news as it represents a potential additional treatment option for initial therapy at diagnosis of the disease," said Cheryl-Anne Simoneau, President and CEO of the CML Society of Canada, who was diagnosed with the cancer ten years ago. "More first line options will help physicians and patients better manage their disease."

About the DASISION studyi
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.  The study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imatinib. The primary study endpoint was the rate of confirmed Complete Cytogenetic Response (CCyR) by 12 months. Secondary endpoints included time-to confirmed CCyR, Major Molecular Response (MMR) rate and time-to MMR.

Detailed Study Results From 18-Month Follow-Upii
In the DASISION study, 78% of patients treated with SPRYCEL® (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). MMR at any time was 57% for patients treated with SPRYCEL vs. 41% for patients treated with imatinib (p=0.0002). Transformation to accelerated or blast phase occurred in 6 patients receiving SPRYCEL and 9 patients receiving imatinib.

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. Thrombocytopenia occurred in 19% of those treated with SPRYCEL and 10% of those treated with imatinib. Neutropenia occurred in 22% of those treated with SPRYCEL and 20% of those treated with imatinib.

About CML
Chronic myeloid leukemia (CML), one of four known types of leukemia, is a slowly progressing cancer of the blood and bone marrow characterized by an overproduction of white blood cells. When the white blood cells produce uncontrollably, they do not mature to carry out their intended function and ultimately crowd out the healthy cells.iii  

CML is distinguished from the other types of leukemia by a genetic abnormality in the white blood cells called the Philadelphia chromosome which promotes the growth of leukemia cells and seems to be present in nearly 90 per cent of CML cases.iv The Philadelphia chromosome is thought to be acquired after birth and is formed when two chromosomes (9 and 22) switch some of their gene material, forming a new chromosome.

In Canada, there are approximately 460 new cases of CML each year, which represents 1 case for every 100,000 people. It is estimated that approximately 3,000 Canadians are currently living with this very rare form of leukemia, which usually occurs during or after middle age.iii 

SPRYCEL® (dasatinib) is indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate. Approval of SPRYCEL in CML is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimum of 24 months of follow-up.

SPRYCEL is also indicated for the treatment of adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Approval in Ph+ ALL is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimum of 24 months of follow-up.vi

SPRYCEL is an oral therapy.  The recommended starting daily dose is 100 mg for chronic phase CML, administered once a day in the morning or in the evening. The medication can be taken with or without food. 

SPRYCEL is available in more than 25 countries including the United States, Austria, Germany, France, Sweden and the United Kingdom.

About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Bristol-Myers Squibb Canada is a leading provider of medicines to fight cancer, cardiovascular and metabolic disorders, infectious diseases (including HIV/AIDS), nervous system diseases and serious mental illness. Bristol-Myers Squibb Company is listed on the New York Stock Exchange under the BMY symbol (NYSE: BMY). Bristol-Myers Squibb Canada's operations are headquartered in Montréal, Québec.

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company used under license by Bristol-Myers Squibb Canada

Gleevec is a registered trademark of its respective owner and not of Bristol-Myers Squibb Company


i 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.

ii "SPRYCEL® (dasatinib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to   Gleevec®ii in Study of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase," Bristol-Myers Squibb Press Release, June 5, 2010.

iii CML Society of Canada Understanding CML.  Available at: http://www.cmlsociety.org/?q=node/14. Last viewed on January 7, 2011.

iv Faderl S, Talpaz M, Estrov Z, et al. The Biology of Chronic Myeloid Leukemia. N Engl J Med 1999;341(3):164-172

v Medicinenet.com Definition of Philadelphia Chromosome  (Ph)  Available at: http://www.medterms.com/script/main/art.asp?articlekey=4870. Last viewed on January 7, 2011.

vi Bristol-Myers Squibb Canada SPRYCEL Product Monograph Revised November 17, 2009


For further information:

or to arrange an interview, please contact:

Sabrina Tremblay
Senior Manager, Public Affairs        
Bristol-Myers Squibb Canada  
514 333-2463 
Katie Lofquist
Hill & Knowlton

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