-- Unprecedented 83 percent two-year event-free survival achieved --
-- Complete and near complete response rate of 84 percent maintained at two
years --
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today reported on results presented by the University
of Arkansas for Medical Sciences and the Center for Cancer Research and
Biostatistics on Total Therapy 3 (TT3). TT3, a treatment for newly
diagnosed multiple myeloma patients, includes a VELCADE based therapy prior
to and as maintenance following stem cell transplantation. These results
showed a significant improvement over previously reported results from
Total Therapy 2 (TT2), a current standard of care, which did not include
VELCADE. The data were presented at the 43rd Annual Meeting of the American
Society of Clinical Oncology (ASCO) in Chicago.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"The inclusion of VELCADE in Total Therapy treatment substantially
improves long-term patient outcomes and further supports VELCADE as an
important therapy in the front-line treatment setting," said Bart Barlogie,
M.D., Ph.D., Director, Myeloma Institute for Research and Therapy,
University of Arkansas for Medical Sciences. "While TT2 was successful, the
VELCADE based combination achieved superior, statistically significant
improvement in event- free survival and complete response rates."
Phase II Study of Total Therapy 3 (TT3) with Added Bortezomib (V) for
Multiple Myeloma (MM) (Abstract #8020)
Dr. Barlogie presented results of this Phase II study in TT3 at
two-year follow-up. Data showed:
-- A complete response (CR) and near complete response (nCR) rate of 84
percent with TT3, a statistically significant improvement over TT2 at
68 percent
-- An event-free survival of 83 percent with TT3, a statistically
significant improvement over TT2 at 75 percent
-- A strong trend for improved overall survival in high-risk patients
under the age of 65 for TT3 compared to TT2
-- Fewer patients on TT3, compared to TT2, experienced grade 3 and 4 side
effects including tremor, constipation, syncope and thromboembolic
events
The study included 303 patients. Patients received two cycles of a
combination called VTD-PACE (VELCADE, thalidomide, dexamethasone,
cisplatin, adriamycin, cyclophosphamide and etoposide) as induction therapy
prior to and as consolidation therapy following stem cell transplantation.
Patients were then given a combination of VTD (VELCADE, thalidomide and
dexamethasone) once monthly for one year and a combination of TD
(thalidomide and dexamethasone) once monthly for two additional years. The
TT2 trial, presented at ASCO 2005, included 323 patients who received the
same therapy without VELCADE.
About Multiple Myeloma (MM)
Multiple myeloma 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 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. will
co-promote VELCADE in the U.S. VELCADE is approved in more than 80
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 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 multiple myeloma and mantle cell
lymphoma studies, the most commonly reported adverse events were asthenic
conditions (64%), nausea (55%), diarrhea (52%), constipation (41%),
peripheral neuropathy (39%), thrombocytopenia (36%), appetite decrease,
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. The most commonly reported serious adverse events 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. 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.
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
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Media, Jennifer Snyder, +1-617-448-0281, or
Investors, Kyle Kuvalanka, +1-857-498-0818
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