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, June 6, 2011 /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.