Eisai Inc. and Janssen, a Johnson & Johnson Company, both
announced the presentation of data from the DACO-016 trial of
DACOGEN® (decitabine) at the 2011 Annual Meeting of the American
Society of Clinical Oncology (ASCO). The data demonstrate a
clinical improvement in overall survival in older patients with
newly diagnosed de novo or secondary acute myeloid leukemia (AML)
as defined by the World Health Organization (WHO). AML is a
life-threatening cancer of the blood for which there are limited
treatment options.
DACO-016 compared decitabine to a patient’s treatment choice
with physician advice of either supportive care or low-dose
cytarabine in the treatment of older patients with AML, the primary
endpoint of the study was overall survival. The analysis at the
protocol-specified cutoff with 396 (81.6%) deaths demonstrated an
increase of greater than 50% in median overall survival in patients
taking decitabine (7.7 months for decitabine patients compared to
5.0 months for patients in the comparator arm), HR=0.85, 95% CI:
0.69, 1.04, p=0.108. An updated unplanned analysis of more mature
survival data with additional one year of patient follow up and 446
(92%) deaths confirmed this trend for improved overall survival
(HR=0.82; 95% 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, randomized,
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 randomized to decitabine and 243 to
patient’s treatment choice of supportive care or low-dose
cytarabine (majority of patients, 88% received low-dose
cytarabine). 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 commonly reported Grade 3 or 4 adverse events were
thrombocytopenia (reported in 40%, 32%, and 35% and 14% of subjects
in the Dacogen, treatment choice, cytarabine and supportive care
groups, respectively), anemia (34%, 25%, 27% and 14% respectively),
neutropenia (32%, 42%, 20% and 3% respectively) and febrile
neutropenia (32%, 22%, 25% and 0% respectively).
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.
Eisai Inc. manages the product rights in the United States,
Canada and Mexico and Janssen-Cilag International NV and other
affiliates of Cilag GmbH International manage the marketing and
development rights for DACOGEN in all other markets.
Dacogen is approved in selected markets for treatment of
patients with myelodysplastic syndromes (MDS), including previously
treated and untreated, de novo and secondary MDS of all
French-American-British (FAB) subtypes (refractory anemia,
refractory anemia with ringed sideroblasts, refractory anemia with
excess blasts, refractory anemia with excess blasts in
transformation, chronic myelomonocytic leukemia), and
Intermediate-1, Intermediate-2 and High-Risk International
Prognostic Scoring System (IPSS) groups.
Important Safety Information
Treatment with DACOGEN is associated with neutropenia and
thrombocytopenia. Complete blood and platelet counts should be
performed as needed to monitor response and toxicity but at a
minimum prior to each dosing cycle. After administration of the
recommended dosage for the first cycle, treatment for subsequent
cycles should be adjusted if indicated by dose adjustment
guidelines. Clinicians should consider the need for early
institution of growth factors and/or antimicrobial agents for the
prevention or treatment of infections in patients with MDS.
DACOGEN may cause fetal harm when administered to a pregnant
woman. Women of childbearing potential should be advised to avoid
becoming pregnant while receiving treatment with DACOGEN and for 1
month following completion of treatment. Women of childbearing
potential should be counseled to use effective contraception during
this time. Men should be advised not to father a child while
receiving treatment with DACOGEN and for 2 months following
completion of treatment. DACOGEN may cause fetal harm. Men with
female partners of childbearing potential should use effective
contraception during this time.
In the phase 3 clinical trial, the highest incidence of Grade 3
or Grade 4 adverse events in the DACOGEN arm was neutropenia (87%),
thrombocytopenia (85%), febrile neutropenia (23%), and leukopenia
(22%). Bone marrow suppression was the most frequent cause of dose
reduction, delay, and discontinuation. Six patients had fatal
events associated with their underlying disease and
myelosuppression (anemia, neutropenia, and thrombocytopenia) that
were considered at least possibly related to drug treatment. Of the
83 DACOGEN-treated patients, 8 permanently discontinued therapy for
adverse events compared to 1 of 81 patients in the supportive care
arm.
In the single-arm study, the highest incidence of Grade 3 or
Grade 4 adverse events was neutropenia (37%), thrombocytopenia
(24%), and anemia (22%). Seventy-eight percent of patients had dose
delays, the median duration of this delay was 7 days. Hematologic
toxicities and infections were the most frequent causes of dose
delays and discontinuation. Eight patients had fatal events due to
infection and/or bleeding that were considered at least possibly
related to drug treatment. Nineteen of 99 patients permanently
discontinued therapy for adverse events.
Other commonly occurring reactions include fatigue, pyrexia,
nausea, cough, petechiae, constipation, diarrhea, and
hyperglycemia.
If hematologic recovery from a previous DACOGEN treatment cycle
requires more than 6 weeks when administering the 3-day dosing,
then the next DACOGEN cycle should be delayed and dosing
temporarily reduced. When administering the 5-day dosing, the
DACOGEN cycle should be delayed until there is hematologic
recovery. If the following nonhematologic toxicities are present,
DACOGEN treatment should not be restarted until the toxicity is
resolved: (1) serum creatinine ≥2 mg/dL; (2) SGPt, total bilirubin
≥2 × ULN; and (3) active or uncontrolled infection.
Because there are no data on use of DACOGEN in patients with
renal or hepatic dysfunction, DACOGEN should be used with caution
in these patients.
For DACOGEN full prescribing information, please click here.
About SuperGen
SuperGen is a pharmaceutical company dedicated to the discovery
and development of novel cancer therapeutics in epigenetic and cell
signaling modulation. The Company develops products through
biochemical and clinical proof of concept to partner for further
development and commercialization. SuperGen developed Dacogen and
receives significant royalties on global sales.
On April 6, 2011, SuperGen entered into a definitive merger
agreement to acquire Astex Therapeutics Limited, a UK based
biotechnology company. The transaction is subject to customary
regulatory, legal and shareholder approvals.
For more information about SuperGen, please visit
http://www.supergen.com.
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