Tous Actualités
Suivre
Abonner Bristol-Myers Squibb SA

Bristol-Myers Squibb SA

Study of SPRYCEL(TM) (Dasatinib) or 800 MG of Imatinib-Mesylate Shows Patients Treated With SPRYCEL Achieved High Cytogenetic Responses and Prolonged Progression-Free Survival

Paris (ots/PRNewswire)

- New Data Presented at the 48th Annual Meeting and Exposition of
the  American Society of Hematology (ASH)
For Non-US Journalists Only
New data presented today showed that a substantial number of
patients with chronic-phase chronic myelogenous leukaemia (CML)
resistant to imatinib mesylate achieved cytogenetic and haematologic
responses within three months and maintained these responses through
one year when treated with SPRYCEL(TM) (dasatinib, formerly known as
BMS-354825). The randomised Phase II open-label, multi-centre
international trial was designed to examine the efficacy and safety
of SPRYCEL at 70mg twice daily or an increased dose of imatinib
mesylate to 800mg/day (patients enrolled in the trial had been
previously treated with imatinib mesylate less than or equal to
600mg/day).(1)
"This study may help answer important questions about treating
resistant chronic-phase CML patients and suggests that physicians
should consider treatment with SPRYCEL in patients resistant to lower
doses of imatinib mesylate," said Neil Shah, MD, PhD, Assistant
Professor, Division of Hematology/Oncology, University of California,
San Francisco.
Analysis of the data at three months and 15 months follow-up show
that the number of patients who achieved and maintained a major
cytogenetic response increased from 36 percent to 53 percent with
SPRYCEL, and from 29 percent to 33 percent with escalated doses of
imatinib mesylate.
While the study was not powered to compare SPRYCEL to high-dose
imatinib mesylate, analysis of the data after a median follow-up of
15 months show a statistically significant difference between SPRYCEL
and high-dose imatinib mesylate in major and complete cytogenetic
responses (p=0.023 and p=0.004, respectively), major molecular
response (p=0.038) and progression-free survival (length of time
during which the leukaemia does not progress) (p<0.0001).
Study Design and Results
This international, open-label, randomized Phase II study (START
R, 017) was conducted in 23 countries. The study evaluated adult
patients with chronic-phase CML who had primary or acquired
resistance to 400-600mg doses of imatinib mesylate. Patients were
randomized in a 2:1 ratio to start treatment with SPRYCEL 70mg twice
a day (bid) (n=101) or imatinib mesylate 400mg bid (n=49). The
primary endpoint of the study was major cytogenetic response rate at
12 weeks. Secondary efficacy endpoints included duration of, and time
to achieve, major cytogenetic response as well as complete
haematologic response. Major cytogenetic response is defined as
complete (no signs of Philadelphia chromosome positive [Ph+] cells in
the bone marrow) plus partial (less than 35 percent of Ph+ cells in
the bone marrow) cytogenetic responses. Complete haematologic
response is a measure of how effective a treatment is in returning
blood counts to normal and occurs when blood counts appear normal and
patients have no signs or symptoms of disease.
Important non-haematologic adverse events of any severity in the
SPRYCEL arm included diarrhoea (35%), nausea (24%), pleural effusion
(17%), superficial oedema (15%), vomiting (9%), pulmonary oedema
(3%), and muscle spasm (2%). Important non-haematologic adverse
events in the imatinib mesylate arm included superficial oedema
(39%), nausea (33%), diarrhoea (29%), vomiting (25%), and muscle
spasm (12%). Grade 3 or 4 cytopenias observed in the SPRYCEL arm
included low absolute neutrophil blood count (59%), platelets (55%),
leukocytes (20%), and haemoglobin (18%). Grade 3 or 4 cytopenias
observed in the imatinib mesylate arm included low absolute
neutrophil white blood cells (39%), leukocytes (16%), platelets
(14%), and haemoglobin (8%).
About SPRYCEL
SPRYCEL, which has been granted orphan drug status, received rapid
approval from regulatory authorities in Europe for the treatment of
adults with chronic, accelerated or blast phase chronic myeloid
leukaemia (CML) with resistance or intolerance to prior therapy,
including imatinib mesylate in November 2006. SPRYCEL is also
indicated for the treatment of adults with Philadelphia chromosome
positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast
CML with resistance or intolerance to prior therapy.
    Resistance to therapy is thought to involve the following mechanisms:(2)
    - mutations of Bcr-Abl, the key protein responsible for CML and Ph+ ALL
    - overexpression of Bcr-Abl
    - other proteins involved in cancer pathways, such as the Src pathway,
      which is thought to play a role in CML and Ph+ ALL as well as other
      cancers.
Mutations can change the shape of the Bcr-Abl protein. When this
happens, imatinib mesylate, the current standard treatment, may be
unable to block its activity. SPRYCEL is an oral, multi-targeted
therapy that can inhibit the action of Bcr-Abl in the presence of all
but one known mutation.(3,4)
The European Medicines Agency reviewed the efficacy and safety of
SPRYCEL based on the analysis of five Phase II multi-centre studies
in patients with resistance or intolerance to imatinib mesylate in
all phases of CML or Ph+ ALL.(2) The studies were conducted on five
continents (33 countries) and SPRYCEL was shown to have a predictable
and manageable side-effect profile.
In the 911 patients receiving SPRYCEL in clinical trials, the most
common side effects were fluid retention (including pleural effusion
and peripheral oedema), gastrointestinal (diarrhoea, nausea and
vomiting), skin rash, headache, haemorrhage, fatigue, and dyspnoea
(difficulty in breathing).
Myelosuppression (a reduction in blood-cell production by the bone
marrow) was reported in all studies and was generally reversible. The
frequency was higher in patients with advanced CML or Ph+ ALL than in
chronic phase CML.(2)
Full SPRYCEL Product Information and the European Public
Assessment Report (EPAR) will be available at www.emea.europa.eu
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development
and exhaustive exploration of innovative cancer-fighting therapies
that extend and enhance the lives of patients living with cancer.
More than 40 years ago, Bristol-Myers Squibb built a unified vision
for the future of cancer treatment. With expertise, dedication and
resolve, that vision led to the development of a diverse global
portfolio of anti-cancer therapies that are an important cornerstone
of care today. Hundreds of scientists at Bristol-Myers Squibb's
Pharmaceutical Research Institute are studying ways to improve
current cancer treatments and identify better, more effective
medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
life.
    References
    1. Shah N, Pasquini R, Rousselot P et al. Dasatinib (SPRYCEL) vs
       escalated dose of imatinib in patients with chronic phase chronic
       myeloid leukemia resistant to imatinib: Results of the CA180-017
       START-R randomized study. Abstract no. 167. 11 December 2006,
       American Society of Hematology, Orlando, Florida, USA.
    2. SPRYCEL(TM) Summary of Product Characteristics.
    3. Talpaz M, Shah NP, Kantarijian H et al. N Engl J Med 2006;354:2531-41.
    4. O'Hare T, Walters DK, Stoffregen EP et al. Cancer Res 2005;65:4500-5.

Contact:

Media contact: Yvette Venable, Bristol-Myers Squibb, Tel:
+33-1-58-83-81-89, Mobile: +33-6-31-43-76-26, Email:
yvette.venable@bms.com

Plus de actualités: Bristol-Myers Squibb SA
Plus de actualités: Bristol-Myers Squibb SA
  • 01.12.2006 – 09:41

    "One Vision 2007" Competition Launches Today

    Paris (ots/PRNewswire) - - Photographers From Across Europe Invited to Participate in Contest to Fight Stigma and Discrimination of HIV/AIDS Patients. Bristol-Myers Squibb announced today - World AIDS Day - the launch of the fourth edition of the One Vision European photography competition, an initiative that is literally helping to change the image of HIV and AIDS across Europe. "People are living longer ...

  • 09.11.2006 – 17:53

    Two-Year Data for Abatacept Demonstrate Continued Efficacy in Adults With Rheumatoid Arthritis

    Paris, November 9 (ots/PRNewswire) - - Data to be Presented at Upcoming American College of Rheumatology Annual Meeting Bristol-Myers Squibb Company (NYSE: BMY) today announced that two-year data from three Phase III pivotal trials demonstrate the long-term efficacy of abatacept in adult patients with moderate to severe rheumatoid arthritis (RA) who have ...