- VELCADE based therapy achieved highly significant improvement across all
efficacy endpoints including overall survival -
ATLANTA, Dec. 9 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced the presentation of results from the
682 patient, randomized, Phase III VISTA(1) trial. These patients with
previously untreated multiple myeloma (MM) were ineligible for stem cell
transplantation (SCT). The trial compared VELCADE, melphalan and prednisone
(VcMP) to melphalan and prednisone (MP) alone, a recognized standard of
care in this treatment setting. These data were selected for an oral
presentation at the American Society of Hematology (ASH) 49th Annual
Meeting in Atlanta, Ga., December 8-11, 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"The goal of therapy is long-term survival and complete remission is a
well-known indicator for survival," said Professor Jesus San-Miguel, M.D.,
Hematology Department Head, University Hospital of Salamanca and Principal
Investigator of the trial. "Data from this rigorously-controlled trial
clearly show that VELCADE based therapy should be a standard of care for
previously untreated patients, who are not able to receive stem cell
transplantation."
Data from the large international clinical trial were presented by
Professor San-Miguel. Responses were evaluated by the commonly used
M-protein levels measured in serum or urine by a centralized laboratory as
well as the most stringent European Group for Blood and Marrow
Transplantation (EBMT) criteria:
-- Immunofixation-negative complete remission (CR) rate of 35 percent in
the VcMP arm compared to 5 percent with MP (p<0.000001); EBMT criteria
showed a CR rate of 30 percent in the VcMP arm compared to 4 percent
with MP
-- The median duration of response was 24 months for patients with CR in
VcMP compared to 13 months with MP
-- Time-to-disease progression (TTP) in the VcMP arm of 24 months
compared to 17 months with MP (p=0.0000001)
-- VcMP demonstrated statistical significance in overall survival with a
40 percent reduction in risk of death (p=0.0078); median survival was
not reached despite a short follow-up of 16 months
-- The median treatment duration was 46 weeks and discontinuation due to
adverse events was low and similar in both arms
"This VELCADE based therapy offers patients durable and complete
remissions, formerly only accessible to transplant patients," said Nancy
Simonian, M.D., Chief Medical Officer, Millennium. "We are filing a sNDA
this month to seek approval in this important treatment setting, which
could significantly increase the number of patients eligible to benefit
from VELCADE."
Patients in the VcMP arm received VELCADE at 1.3 mg/m2 twice weekly in
weeks one, two, four and five for four six-week cycles (eight doses per
cycle), followed by once weekly on weeks one, two, four and five for five
six- week cycles (four doses per cycle) in combination with melphalan at 9
mg/m2 and prednisone at 60 mg/m2 once daily on days 1 through 4 of each
cycle. Patients in the MP arm received nine six-week cycles of MP once
daily on days 1 through 4. For both groups, treatment continued for a
maximum of 54 weeks (52 vials) with a median number of 46 weeks (44 vials)
reported in the trial. The safety profile of VcMP was as expected based on
the known safety profile of each of the three individual agents in the
combination, including neutropenia, thrombocytopenia, anemia and peripheral
neuropathy.
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 of age), recent statistics indicate both
increasing incidence and younger age of onset. In the U.S., more than
55,000 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, 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. are
co-promoting VELCADE in the U.S. VELCADE is approved in more than 85
countries worldwide.
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
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 2 and 3 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. This integrated analysis does not include the phase 3, VELCADE plus
DOXIL study.
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. Millennium'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. Millennium'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.
(1) VELCADE as Initial Standard Therapy in multiple myeloma: Assessment
with melphalan and prednisone
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 448-0281 (857) 498-0818
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
SOURCE Millennium Pharmaceuticals, Inc.
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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:
http://www.prnewswire.com/comp/114562.html /
CONTACT:
Media, Jennifer Snyder, +1-617-448-0281,
Investors, Kyle Kuvalanka, +1-857-498-0818, both of Millennium
Pharmaceuticals, Inc.
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