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

By Janssen, PRNE
Sunday, June 5, 2011

CHICAGO and BEERSE, Belgium, June 6, 2011 -

- 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

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 www.janssen-emea.com

Notes to editors


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.

For further information please contact: Satu Glawe, Communication & Public Affairs EMEA,
Cell +49-172-294-6264, Brigitte Byl, Communication & Public Affairs EMEA,
Phone +32(0)14-60-71-72, Investor Relations, Stan Panasewicz, +1-732-524-2524,
spanase1 at its.jnj.com, Louise Mehrotra, +1-732-524-6491, lmehrot at its.jnj.com

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