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

Description

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.

Informations

• Publié par: bristol-myers-squibb-otsuka-pharmaceutical-europe-ltd
• Nombre de lectures: 11
• Langue: English

Extrait

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, [phone], [e-mail]

Otsuka Pharmaceutical Co., Ltd.

Ali Ross, [phone], [e-mail]