Six-Year Follow-Up Data for SPRYCEL(R) (dasatinib) 100 mg Once Daily Demonstrates 71 Percent Overall Survival in Patients with Chronic-Phase Chronic Myeloid Leukaemia Resistant or Intolerant to Imatinib
PARIS, June 15, 2012 /PRNewswire/ –
Results Presented at 17th Congress of the European Hematology Association
Bristol-Myers Squibb Company (NYSE:BMY) 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.
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%). 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%).
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
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
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. CML accounts for 15% of all leukaemias. The
incidence is estimated at 1-2 cases per 100,000.
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
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:
. 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
Bristol-Myers Squibb Astrid Harmel, +33-1-58-83-61-49, email@example.com
Otsuka Pharmaceutical Co., Ltd. Ali Ross, +44-7768-337128, firstname.lastname@example.org
SOURCE Bristol-Myers Squibb & Otsuka Pharmaceutical Europe Ltd.