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 Imatinib

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 Imatinib

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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 Imatinib PR Newswire PARIS, June 15, 2012 PARIS, June 15, 2012 /PRNewswire/ -- thResults Presented at 17 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 (dasatinib) in Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML) ®adult patients resistant or intolerant to Glivec (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 [1]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): [1]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.

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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 Imatinib
PR Newswire
PARIS, June 15, 2012
PARIS
,
June 15, 2012
/PRNewswire/ --
Results Presented at 17
th
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
®
(dasatinib) in
Philadelphia
chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML)
adult patients resistant or intolerant to Glivec
®
(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 2
nd
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 17
th
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
®
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/Cancertypes/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