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
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.
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.v
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
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
SOURCE BRISTOL-MYERS SQUIBB CANADA
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