- VELCADE dexamethasone combination shows greater than two-fold benefit
over vincristine, adriamycin and dexamethasone therapy -
ORLANDO, Fla., Dec. 10 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today reported that the Intergroupe
Francophone du Myelome (IFM) cooperative group presented preliminary data
from a Phase III clinical trial in newly diagnosed multiple myeloma (MM)
patients treated with VELCADE(R) (bortezomib) for Injection in combination
with dexamethasone as induction therapy prior to stem cell transplantation.
Data showed that the VELCADE and dexamethasone combination achieved a
complete and near complete response (CR/nCR) rate of 20 percent, greater
than a two-fold improvement over the vincristine, adriamycin and
dexamethasone triplet (VAD), a commonly used therapy in this treatment
setting. The trial is part of a comprehensive registration-enabling Phase
III program evaluating VELCADE in the treatment of newly diagnosed MM
patients in the transplant and non- transplant settings. The preliminary
results were reported at the 48th Annual Meeting and Exposition of the
American Society of Hematology (ASH), December 9-12, 2006, in Orlando, Fla.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"These preliminary data are the first to be reported from a randomized
Phase III trial of VELCADE in newly diagnosed patients and represent an
important step in building the evidence for the role of VELCADE in this
treatment setting," said Jean-Luc Harousseau, M.D., of Hospital Hotel-Dieu,
Nantes, France. "Achieving a high CR rate, as seen with VELCADE based
induction therapy prior to stem cell transplantation, is important because
it may lead to improved long-term outcomes for patients. We look forward to
completing the trial."
VELCADE (Bortezomib) Dexamethasone Versus VAD as Induction Treatment
Prior to Autologous Stem Cell Transplantation in Newly Diagnosed Multiple
Myeloma: An Interim Analysis of the IFM 2005-01 Randomized, Multicenter
Phase III Trial (Abstract # 56)
The multicenter, randomized Phase III clinical trial was designed to
compare VELCADE in combination with dexamethasone to VAD as induction
treatment prior to stem cell transplantation in 480 newly diagnosed MM
patients. The preliminary analysis presented at the conference included
data from the first 161 eligible patients enrolled in the trial. The 79
patients in the VELCADE and dexamethasone arm were treated for four 21-day
cycles of VELCADE at its standard dose and schedule of 1.3 mg/m2 on days 1,
4, 8 and 11, with oral dexamethasone at 40 mg/m2 on days one through four
and days nine through 12 for cycles one and two and on days one through
four for cycles three and four. The 82 patients on the VAD arm received
four 28-day cycles of vincristine at 0.4 mg/m2 continuous infusion on days
one through four, adriamycin at 9 mg/m2 continuous infusion for days one
through four and oral dexamethasone at 40 mg/m2 on days one through four,
days nine through 12 and days 17 to 20 for cycles one and two, and on days
one and four for cycles three and four. Data presented were
investigator-assessed responses using modified European Group for Blood and
Marrow Transplantation (EBMT) criteria. Results presented by Professor
Harousseau included:
- VELCADE and dexamethasone showed a CR/nCR rate of 20 percent compared to
a nine percent rate for VAD
- VELCADE and dexamethasone showed a CR and very good partial response
(VGPR) rate of 43 percent compared to a 26 percent rate for VAD
- VELCADE and dexamethasone showed an overall response rate (CR and
partial response) of 82 percent compared to a 67 percent rate for VAD
- VELCADE and dexamethasone was well tolerated; the most common adverse
events were nausea, constipation and anemia
The IFM group continues to enroll patients to achieve the target of 480
patients. Response data for the interim analysis are being determined by an
independent data review committee. An early filing opportunity may be
possible in 2007.
VELCADE is the U.S. market leader in relapsed MM. Previous single-agent
VELCADE studies in relapsed MM have demonstrated unprecedented survival. In
newly diagnosed patients, VELCADE based therapies have achieved transplant-
like results with overall response rates of up to 95 percent and CR/nCR
rates of up to 43 percent. To date, over 50,000 MM patients have been
treated with VELCADE worldwide.
About Multiple Myeloma
MM is the second most common hematologic malignancy and although the
disease is predominantly a cancer of the elderly (the average age of onset
is 65 to 70 years of age), recent statistics indicate both increasing
incidence and younger age of onset. In the U.S., more than 50,000
individuals have MM and over 15,000 new cases are diagnosed each year.
Worldwide there are approximately 74,000 new cases and over 45,000 deaths
annually.(1)
About VELCADE
VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium
is responsible for commercialization of VELCADE in the U.S.; 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. will
co-promote VELCADE in the U.S. VELCADE also is approved in the European
Union after first relapse.
VELCADE is indicated for the treatment of patients with multiple
myeloma who have received at least one prior therapy. VELCADE is indicated
for the treatment of patients with mantle cell lymphoma (MCL) 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.
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 (ARDS) 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 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.
Safety Data: In 1163 patients in MM and MCL studies, the most commonly
reported adverse events were asthenic conditions (64%), nausea (55%),
diarrhea (52%), constipation (41%), peripheral neuropathy (39%),
thrombocytopenia (36%), appetite decreased, including reports of anorexia
(36%), pyrexia (34%), vomiting (33%) and anemia (29%). Twenty percent of
patients reported at least one episode of grade 4 toxicity; the most common
grade 4 toxicities were thrombocytopenia (5%) and neutropenia (3%). Fifty
percent of patients reported serious adverse events (SAEs). The most
commonly reported SAEs were pneumonia (7%), pyrexia (6%), diarrhea (5%),
vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each
3%).
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, Inc., a leading biopharmaceutical company
based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has
a robust clinical development pipeline of product candidates. The Company's
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. The Company's website is 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. For a further list and description of the risks and
uncertainties the Company faces, see the reports it has filed with the
Securities and Exchange Commission. 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.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
(1) American Cancer Society, Overview: Multiple Myeloma, 2005,
http://www.cancer.org
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 448-0281 (857) 498-0818
SOURCE Millennium Pharmaceuticals, Inc.
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Related links:
http://www.millennium.com
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CONTACT:
Jennifer Snyder (media), +1-617-448-0281, or
Kyle Kuvalanka (investors), +1-857-498-0818
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