-- IFM presents updated results from Phase III clinical trial --
CHICAGO, May 31 /PRNewswire/ -- Millennium Pharmaceuticals, The Takeda
Oncology Company, today announced the presentation of updated results from
a 482 patient, multi-center, randomized Phase III clinical trial, comparing
VELCADE and dexamethasone (VcD) to vincristine, adriamycin and
dexamethasone (VAD). Results showed high complete remission (CR) rates of
19 percent in the VcD arm as induction therapy and 35 percent
post-transplantation. These high CR rates contributed to 141 patients not
requiring a second transplant. In addition, data showed 95 percent of
patients in the VcD arm were alive at one year. The study was conducted by
the Intergroupe Francophone du Myelome (IFM) cooperative group and Nantes
University Hospital (France) and selected for an oral presentation at the
American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,
Illinois, May 30 - June 3, 2008.
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"These updated results clearly confirm that the high CR rates with
induction therapy improved post-transplantation outcomes, including a
decrease in the need for second transplantation," said Professor
Harousseau, M.D., Hotel-Dieu Hospital. "We also are encouraged by the
promising survival data already seen to date. This VELCADE based therapy
now could be considered the standard induction treatment pre-transplant to
which other regimens, including novel agents, should be studied against."
VELCADE is under priority review with the Food and Drug Administration
(FDA) for potential approval in newly diagnosed multiple myeloma. The PDUFA
date is June 20, 2008. VELCADE is the market leader in relapsed multiple
myeloma and mantle cell lymphoma (MCL).
"These data, as well as the results from multiple clinical trials
continue to demonstrate the ability of VELCADE to deliver consistently high
complete remission rates that lead to improved clinical benefit, including
survival," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
"The updated results from the IFM, combined with the pending approval by
the FDA, bring us one step further in establishing VELCADE as the
foundation of therapy for patients with newly diagnosed multiple myeloma."
Results from this large clinical trial were presented by Professor
Harousseau. The VcD arm versus the VAD arm showed:
-- 95 percent of patients were alive at one year compared to
92 percent
-- A CR rate of 19 percent compared to 8 percent as induction therapy
(p=0.0004)
-- A CR rate of 35 percent compared to 23 percent post-transplantation
(p=0.0063)
-- 63 percent of patients did not require a second transplantation
compared to 44 percent (p<0.0001)
Patients in the VcD arm received four cycles of VELCADE at 1.3 mg/m2 on
days 1, 4, 8 and 11 of a 21-day cycle. Patients also received dexamethasone
at 40 mg on days 1 through 4 during cycles one through four and on days 9
through 12 during cycles one and two only. The patients in the VAD arm were
treated for four 28-day cycles with vincristine at 0.4 mg/m2 on days 1
through 4; adriamycin at 9 mg/m2 on days 1 through 4; and dexamethasone at
40 mg on days 1 through 4, days 9 through 12 during cycles one through four
and on days 17 through 20 during cycles one and two only. Half of the
patients in each arm received dexamethasone, cyclophosphamide, etoposide
and cisplatinum (DCEP) consolidation pre-transplant. VcD was well tolerated
with the incidence of grade 3 and grade 4 adverse events similar in each
arm. Serious adverse events were slightly lower with VcD.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy and
although the disease is predominantly a cancer of the elderly (the median
age of onset is 70 years), recent statistics indicate both increasing
incidence and younger age of onset. In the U.S., more than 50,000
individuals have MM and 20,000 new cases are diagnosed each year. Worldwide
there are approximately 74,000 new cases and over 45,000 deaths annually.
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, The Takeda
Oncology Company, and Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. Millennium is responsible for commercialization of
VELCADE in the U.S. and Janssen-Cilag is responsible for commercialization
in Europe and the rest of the world. Janssen Pharmaceutical K.K. is
responsible for commercialization in Japan. For a limited period of time,
Millennium and Ortho Biotech Inc. are co-promoting VELCADE in the U.S.
VELCADE is approved in 85 countries worldwide. More than 100,000 patients
have been treated with VELCADE globally.
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma who have received at least one prior therapy. VELCADE is
also indicated for the treatment of patients with mantle cell lymphoma who
have received at least one prior therapy. VELCADE is contraindicated in
patients with hypersensitivity to bortezomib, boron or mannitol. VELCADE
should be administered under the supervision of a physician experienced in
the use of antineoplastic therapy. In the European Union and many other
countries worldwide, VELCADE is approved for patients with multiple myeloma
after first relapse.
Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension observed throughout therapy, cardiac and
pulmonary disorders, gastrointestinal adverse events, thrombocytopenia,
neutropenia and tumor lysis syndrome. Women of childbearing potential
should avoid becoming pregnant while being treated with VELCADE. Cases of
severe sensory and motor peripheral neuropathy have been reported. The
long-term outcome of peripheral neuropathy has not been studied in mantle
cell lymphoma. Acute development or exacerbation of congestive heart
failure, and/or new onset of decreased left ventricular ejection fraction
has been reported, including reports in patients with few or no risk
factors for decreased left ventricular ejection fraction. There have been
rare reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung infiltration and
Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of
these events have been fatal. A higher proportion of these events have been
reported in Japan. There have been rare reports of Reversible Posterior
Leukoencephalopathy Syndrome (RPLS) in patients receiving VELCADE. RPLS is
a rare, reversible, neurological disorder which can present with seizure,
hypertension, headache, lethargy, confusion, blindness, and other visual
and neurological disturbances. VELCADE is associated with thrombocytopenia
and neutropenia. There have been reports of gastrointestinal and
intracerebral hemorrhage in association with VELCADE. Transfusions may be
considered. Complete blood counts (CBC) should be frequently monitored
during treatment with VELCADE. Rare cases of acute liver failure have been
reported in patients receiving multiple concomitant medications and with
serious underlying medical conditions.
Integrated Safety Data: Safety data from Phase II and III studies of
single-agent VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed by a
10-day rest period in 1163 patients with multiple myeloma (N=1008) and
mantle cell lymphoma (N=155) were integrated and tabulated. In these
studies, the safety profile of VELCADE was similar in patients with
multiple myeloma and mantle cell lymphoma. In the integrated analysis, the
most commonly reported adverse events were asthenic conditions (including
fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%),
constipation (41%), peripheral neuropathy NEC (including peripheral sensory
neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia
and appetite decreased (including anorexia) (each 36%), pyrexia (34%),
vomiting (33%), and anemia (29%). Twenty percent (20%) of patients
experienced at least 1 episode of >/= Grade 4 toxicity, most commonly
thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients
experienced serious adverse events (SAEs) during the studies. The most
commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea
(5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia
(each 3%). Adverse events thought by the investigator to be drug-related
and leading to discontinuation occurred in 22% of patients. The reasons for
discontinuation included peripheral neuropathy (8%), asthenic conditions
(3%) and thrombocytopenia and diarrhea (each 2%). In total, 2% of the
patients died and the cause of death was considered by the investigator to
be possibly related to study drug: including reports of cardiac arrest,
congestive heart failure, respiratory failure, renal failure, pneumonia and
sepsis.
For more information about VELCADE clinical trials, patients and
physicians can contact the Millennium Medical Product Information
Department at 1-866-VELCADE (1-866-835-2233).
About Millennium
Millennium Pharmaceuticals, The Takeda Oncology Company, a leading
biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a
novel cancer product, and has a robust clinical development pipeline of
product candidates. Millennium research, development and commercialization
activities are focused in two therapeutic areas: oncology and inflammation.
By applying its knowledge of the human genome, understanding of disease
mechanisms and industrialized drug discovery platform, Millennium is
developing an exciting pipeline of innovative product candidates.
Additional information about Millennium is available through its website,
http://www.millennium.com.
This press release contains "forward-looking statements," including
statements about the Company's growth and development of products. Various
important risks may cause the Company's actual results to differ materially
from the results indicated by these forward-looking statements, including:
adverse results in its drug discovery and clinical development programs;
failure to obtain patent protection for its discoveries; commercial
limitations imposed by patents owned or controlled by third parties; the
Company's dependence upon strategic alliance partners to develop and
commercialize products and services based on its work; difficulties or
delays in obtaining regulatory approvals to market products and services
resulting from its development efforts; product withdrawals; competitive
factors; difficulties or delays in manufacturing the Company's products;
government and third-party reimbursement rates; the commercial success of
VELCADE and INTEGRILIN(R) (eptifibatide) Injection; achieving revenue
consistent with internal forecasts; and the requirement for substantial
funding to conduct research and development and to expand commercialization
activities. The Company disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
Media Contacts:
Jennifer Snyder Karen Gobler
(617) 444-1439 (617) 444-1392
SOURCE Millennium Pharmaceuticals
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Related links:
http://www.millennium.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http:
CONTACT:
Jennifer Snyder, +1-617-444-1439, or Karen
Gobler, +1-617-444-1392, both of Millennium Pharmaceuticals
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