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[*]

PARIS, June 10, 2011 /PRNewswire/ --

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 (24%).

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 imatinib."

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.

About SPRYCEL

Dasatinib, an oral BCR-ABL inhibitor, was initially approved in November 2006 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.

References

[1]. Macmillan Cancer Support. Leukaemia Overview. Available at: http://www.macmillan.org.uk/Cancerinformation/Cancertypes/Leukaemia/Leukaemia 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 AG.