Five-Year Follow-Up Data for SPRYCEL(R) (dasatinib) 100 mg Once Daily Demonstrated 78 Percent Overall Survival in Patients with Chronic-Phase Chronic Myeloid Leukaemia Resistant or Intolerant to Imatinib Mesylate[*]

By Bristol-myers Squibb, PRNE
Thursday, June 9, 2011

PARIS, June 10, 2011 -

Five-year follow-up results were presented today from a Phase 3
randomised, open-label, dose-optimisation study of SPRYCEL(R) (dasatinib) in
Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid
leukaemia(CP-CML) adult patients resistant or intolerant to imatinib
mesylate. At five years, for patients randomised to receive dasatinib 100 mg
once daily (n=167), overall survival was 78% (95% CI: 72%-85%) and
progression-free survival was 57% (95% CI: 48%-67%). Five percent of patients
(n=8) randomised to dasatinib 100 mg once daily progressed to accelerated or
blast phase on study at five years of follow-up.

The five-year safety data from this study are consistent with the
previously-reported safety profile of dasatinib 100 mg once daily. The
cumulative incidence of grade 3/4 pleural effusion was 4%. Other grade 3/4
adverse events (AEs) with cumulative rates greater than or equal to 5%
included neutropenia (36%), thrombocytopenia (24%), leukopenia (18%), and
anaemia (13%). The cumulative incidence rates of the most common
non-hematological AEs of all grades at five years of follow-up were: headache
(33%), diarrhoea (28%), fatigue (26%), dyspnea (24%) and pleural effusion

These data were presented today at the 16th Congress of the European
Hematology Association (EHA) in London (Abstract # 0136).

"In this study, the five-year follow up data demonstrated the long-term
efficacy and consistent safety profile for SPRYCEL 100 mg once daily in
patients with CP-CML following prior imatinib therapy," said Neil Shah, MD,
PhD, Assistant Professor, Division of Hematology/Oncology, University of
California, San Francisco
and principal investigator of the study. "Results
from this SPRYCEL study are important as they provide long-term follow up of
patients with CP-CML treated with SPRYCEL who are resistant or intolerant to

About Study CA180-034

Study CA180-034 was designed to assess the efficacy and safety of
dasatinib 100 mg once daily. The trial enrolled 670 CP-CML patients with
resistance (n=497) or intolerance (n=173) to imatinib who were randomised to
one of four treatment arms: 100 mg once daily (n=167), 50 mg twice daily
(n=168), 140 mg once daily (n=167), and 70 mg twice daily (n=168). In this
heavily pre-treated population, the median time from onset of CML to
randomisation in patients on the 100mg once daily arm was 55 months and 46%
of these patients had more than three years of prior imatinib treatment. Data
on the primary endpoint of the study, major cytogenetic response in
imatinib-resistant patients, have been previously reported. Thirty-four
percent of patients randomised to receive dasatinib 100 mg once daily
remained on treatment at 5 years.


Dasatinib, an oral BCR-ABL inhibitor, was initially approved in November
by the European Commission for the treatment of adults for all phases
of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with
resistance or intolerance to prior therapy including imatinib. Dasatinib
is also approved for the treatment of adults with Philadelphia
chromosome-positive acute lymphoblastic leukaemia with resistance or
intolerance to prior therapy. Since then, dasatinib has been approved
for this indication in more than 60 countries worldwide.
In 2010, dasatinib 100 mg once daily was approved by the FDA and European
Commission for the treatment of adult patients with newly diagnosed Ph+
CML in chronic phase. In the U.S., dasatinib received accelerated FDA
approval for this indication. The effectiveness of dasatinib is based
on cytogenetic response and major molecular response rates. The first-line
trial (known as DASISION) is ongoing and further data will be required to
determine long-term outcome. Now, more than 50 countries have approved
dasatinib for this indication.

About Chronic Myeloid Leukaemia

CML is a slow-growing type of leukaemia in which the body produces an
uncontrolled number of abnormal white blood cells.[1] CML accounts for 15% of
all leukaemias.[2] Due to the ageing population, the incidence of CML is
increasing. The incidence is estimated at 1-2 cases per 100,000.[3]

CML occurs when pieces of two different chromosomes break off and attach
to each other. The new chromosome is called the Philadelphia-positive
chromosome, which contains an abnormal gene called BCR-ABL that signals cells
to make too many white blood cells. There is no known cause for the genetic
change that causes CML.

About 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 over serious diseases.

About Otsuka Pharmaceutical Co., Ltd

Otsuka Pharmaceutical Co., Ltd is a successful, innovative, fast-growing
healthcare company that commercialises Otsuka-discovered and other product
opportunities globally, with a strong focus on and commitment to
neuroscience, cardiovascular, oncologic, and gastrointestinal therapeutic
treatments. Otsuka Pharmaceutical Co., Ltd is dedicated to improving
patients' health and the quality of human life. Otsuka Pharmaceutical Co.,
Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding
company for the Otsuka Group.

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.


[1]. Macmillan Cancer Support. Leukaemia Overview. Available at:
overview.aspx. Last accessed April 2011

(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)

[2]. National Comprehensive Cancer Network (NCCN). Chronic Myelogenous
Leukemia - Clinical Practice Guidelines in Oncology - v.1.2007.

[3]. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167.


[*] Glivec(R) (imatinib mesylate) is a registered trademark of Novartis

Contacts: Bristol-Myers Squibb: European Media Contact: Elzbieta Zawislak, +33615523580, elzbieta.zawislak at; Global Media Contact: Sarah Koenig, +1-609-252-4145, sarah.koenig at

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