DACOGEN(R) (decitabine) Showed an Overall Survival Advantage Compared With the Accepted Standard Therapies in Older Patients With Newly Diagnosed De Novo or Secondary Acute Myeloid Leukemia

Chicago and Beerse, Belgium (ots/PRNewswire) -

- Data From DACO-016 Trial at 2011 American Society of Clinical

Oncology Annual Meeting

- NB: Data in this release corresponds to ASCO abstract 6504

Data from the DACO-016 trial of DACOGEN(R) (decitabine) presented
today at the 2011 Annual Meeting of the American Society of Clinical
Oncology (ASCO), demonstrate a clinically significant improvement in
overall survival in older patients with newly diagnosed de novo or
secondary acute myeloid leukemia (AML) as defined by the World Health
Organisation (WHO).[1] AML is a life-threatening disease that affects
primarily older adults; very limited treatment options exist.

DACO-016 compared decitabine to a patient's choice with physician
advice of either supportive care or low-dose cytarabine in the
treatment of older patients with AML. The analysis of the
protocol-specified results demonstrated a statistically
non-significant increase of greater than 50 percent in median overall
survival in patients taking decitabine (7.7 months for decitabine
patients, (HR=0.85, 95 percent CI: 0.69, 1.04, p=0.108) compared to
5.0 months for patients in the comparator arm). An updated analysis
of mature survival data confirmed this strong trend for improved
overall survival and provided clinically significant evidence of
decitabine efficacy (HR=0.82; 95 percent CI: 0.68, 0.99; nominal
p=0.037).

Dr. Xavier G. Thomas of the Hospital Edouard Herriot in Lyon,
France, one of the lead DACO-016 investigators, comments: "Compared
with the accepted standard therapies used in this study to treat
older patients with AML, DACOGEN showed a clinically relevant overall
survival advantage without major differences in safety."

DACO-016 was conducted in 485 patients, making it the largest AML
trial to date in older patients. It was a Phase 3, randomised,
open-label trial, in newly diagnosed patients =65 years of age with
de novo or secondary AML and poor- or intermediate-risk cytogenetics.
Patients were enrolled globally at 65 clinical sites. Of the 485
patients, 242 were randomised to decitabine and 243 to patient's
treatment choice of supportive care or low-dose cytarabine (majority
of patients, 88%). Patients treated with decitabine received a 1-hour
infusion, once daily for 5 consecutive days every 4 weeks. Patients
treated with cytarabine received 20 mg/m2 subcutaneously once daily
10 consecutive days every 4 weeks. The median duration of treatment
for patients on decitabine arm was 4.4 months, compared with 2.4
months in the cytarabine group.

Adverse events (AEs) were consistent with the known decitabine
safety profile and without major differences between the treatment
arms. The most frequently reported Grade 3 or 4 hematologic AEs were
thrombocytopenia, anemia, neutropenia, and febrile neutropenia.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is an aggressive, fast-growing
cancer that starts inside the bone marrow with production of abnormal
blood cells. It is generally a disease of older adults, with an
average patient age of 64 at diagnosis, and is slightly more common
among men than women. The most common symptoms of AML include
tiredness, shortness of breath, bruising or bleeding easily, fever
and infections. When diagnosed, treatment is to be started with
minimal delay as AML usually results in death within just a few
months if left untreated. AML can sometimes spread to other parts of
the body including the lymph nodes, liver and spleen. In older
adults, induction chemotherapy leads to a high 30-day mortality, and
most patients are not candidates for or are unwilling to undergo this
aggressive therapy. Therefore, treatment options are limited and
overall, irrespective of therapy, median survival is merely 2.4
months.

About DACOGEN (decitabine)

DACOGEN is a DNA hypomethylating agent currently approved for the
treatment of myelodysplastic syndromes (MDS) in more than 30
countries worldwide including key markets such as the United States,
Brazil, China, India, Russia and Turkey.

Janssen-Cilag International NV and other affiliates of Cilag GmbH
International hold marketing and development rights for DACOGEN in
all markets except the United States, Canada and Mexico, where its
rights are maintained by our partner, Eisai Inc. and its affiliates.

About Janssen

Janssen-Cilag International NV is one of the Janssen
Pharmaceutical Companies of Johnson & Johnson, which are dedicated to
addressing and solving the most important unmet medical needs of our
time, including oncology (e.g., multiple myeloma and prostate
cancer), immunology (e.g., psoriasis), neuroscience (e.g.,
schizophrenia, dementia and pain), infectious disease (e.g.,
HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and
metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable,
integrated healthcare solutions by working side-by-side with
healthcare stakeholders, based on partnerships of trust and
transparency. More information can be found at
http://www.janssen-emea.com

Notes to editors

References

1. Thomas XG et al. Results From a Randomised Phase 3 Trial of
Decitabine vs Supportive Care or Low-Dose Cytarabine for the
Treatment of Older Patients With Newly Diagnosed AML. Abstract 6504.

ots Originaltext: Janssen Pharmaceutica
Im Internet recherchierbar: http://www.presseportal.de

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