Six-Year Follow-Up Data for SPRYCEL®? (dasatinib) 100 mg Once Daily Demonstrates 71 Percent Overall Survival in Patients with Chronic-Phase Chronic Myeloid Leukaemia Resistant or Intolerant to Imatini

Paris (ots/PRNewswire) -

Results Presented at 17th Congress of the European
Hematology Association

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Europe
Ltd., today announced six-year follow-up results 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 Glivec(R) (imatinib).

Long-term survival data

The six-year data shows progression-free survival of 49.3% and an
overall survival of 71% for patients randomised to dasatinib 100 mg
once daily (n=167), with 6% of patients (n=10) progressing to
accelerated or blast phase on study at six years of follow-up.[1]

Safety and tolerability data from patients randomized to the 100
mg arm during the six-year follow up are consistent with the
previously reported safety profile of dasatinib 100 mg once daily. In
this 100 mg QD arm, the most common grade 3/4 adverse events (AEs)
were (cumulative 6 year occurrence): neutropenia (36%),
thrombocytopaenia (24%), and anaemia (13%).[1] The cumulative
incidence rates of the most common non-haematological AEs of Grade
3/4 at six years of follow-up were: diarrhoea (4.3%), fatigue (4.3%),
infections (6.1%) and pleural effusion (5.3%).[2]

This is the longest reported follow-up of 2nd generation Tyrosine
Kinase Inhibitors for patients resistant or intolerant to imatinib.

Safety and Tolerability at Six Years

Safety and tolerability data from the six-year study are
consistent with the previously reported safety profile of dasatinib
100 mg once daily. For full information on SPRYCEL (dasatinib) please
refer to SmPC at http://www.ema.europa.eu.

These data were presented today at the 17th Congress of the
European Hematology Association in Amsterdam. (Poster 0199).

About Study CA180-034

Study CA180-034 was designed to assess the efficacy and safety of
dasatinib following intolerance or resistance to imatinib. The trial
enrolled 670 CP-CML patients with resistance (n=497) or intolerance
(n=173) to imatinibwho 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 pre-treated
population, the median time from onset of CML to randomisation in
patients on the 100 mg 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 with
a minimum follow up of 6 months in imatinib-resistant patients, have
been previously reported. Thirty-one percent of patients randomised
to receive dasatinib 100 mg once daily remained on treatment at 6
years.[1]

About SPRYCEL(R)

Discovered and developed by Bristol-Myers Squibb, dasatinib was
initially approved by the FDA and the European Commission in 2006 as
a treatment for adults for all phases of Ph+ CML (chronic,
accelerated, or myeloid or lymphoid blast phase) with resistance or
intolerance to prior therapy including imatinib and Philadelphia
chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL)
intolerant or resistant to prior therapy. In the U.S., dasatinib
received accelerated FDA approval for this indication. 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 Leukemia

CML is a slow-growing type of leukaemia in which the body
produces an uncontrolled number of abnormal white blood cells.[3] CML
accounts for 15% of all leukaemias.[4] The incidence is estimated at
1-2 cases per 100,000.[5]

CML occurs when pieces of two different chromosomes (9 and 22)
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.

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.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of
Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group.
The Otsuka Group has business operations in 23 countries and regions
around the world.

Visit Otsuka Pharmaceutical Co., Ltd. at
http://www.otsuka.co.jp/en.

References: 1. Rea, D., et al. Six-year follow-up of patients
with imatinib-resistant or imatinib-intolerant chronic-phase chronic
myeloid leukemia (CP-CML) receiving dasatinib. To be presented at:
17th Congress of the European Hematology Association (EHA); June
14-17, 2012; Amsterdam, The Netherlands. 2. Shah, N., et al. Six-year
follow-up of patients with imatinib-resistant or -intolerant
chronic-phase chronic myeloid leukemia (CML-CP) receiving dasatinib.
Oral Presentation at: 2012 American Society of Clinical Oncology
Annual Meeting. 3.Macmillan Cancer Support. Leukaemia Overview.
Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertyp
es/Leukaemia/Leukaemiaoverview.aspx . Last accessed April 2012. 4.
National Comprehensive Cancer Network (NCCN). Chronic Myelogenous
Leukemia - Clinical Practice Guidelines in Oncology - v.1.2007. 5.
Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167.

UK job codes: 729UK12NP019 / OPUK/0612/SPC/2016, date of
preparation June 2012

Media Contacts

Bristol-Myers Squibb
Astrid Harmel, +33-1-58-83-61-49, astrid.harmel@bms.com

Otsuka Pharmaceutical Co., Ltd.
Ali Ross, +44-7768-337128, aross@otsuka-europe.com

ots Originaltext: Bristol-Myers Squibb & Otsuka Pharmaceutical Europe Ltd.
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