- 100 percent of patients treated with VELCADE, cyclophosphamide, and
prednisone alive at one year -
KOS, Greece, June 28 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today reported on the presentation of
results from clinical trials of VELCADE based therapies that showed high
complete remission / complete response(1) (CR) rates in previously treated
multiple myeloma (MM) patients. These findings were presented at the
prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece.
Highlights included:
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
-- VELCADE, cyclophosphamide and prednisone (VCP) demonstrated an overall
response rate (ORR) of 93 percent including a CR(1) rate of 54 percent.
At one year, 100 percent of patients were alive.
-- VELCADE, lenalidomide and dexamethasone (VRD) showed an ORR of 68
percent with a 5 percent CR(1) rate in a pilot study of heavily
pretreated patients, including those who had been previously treated
with VELCADE or lenalidomide.
"By combining the power of VELCADE with other active agents, we are
seeing some of the strongest reported efficacy in previously treated
multiple myeloma patients," said Nancy Simonian, M.D., Chief Medical
Officer, Millennium. "The wealth of combination data that are being
generated promises to strengthen the U.S. market-leading role of VELCADE."
Weekly VELCADE, Cyclophosphamide and Prednisone in Myeloma (Abstract
#PO- 639)
"VELCADE has shown synergistic activity with alkylating agents by
generating substantially high and durable complete remission rates," said
Donna Reece, M.D., Princess Margaret Hospital. "This is an important
finding for the field of multiple myeloma and leads us to believe that the
combination of VELCADE and cyclophosphamide warrants further investigation
in the front-line setting with the goal of prolonging patients' survival."
The Phase II study was designed to evaluate the efficacy and safety of
VCP in relapsed / refractory MM patients. The study included 13 evaluable
patients, who received VELCADE at 1.5 mg/m2 on days 1, 8 and 15 of a 28-day
schedule. Patients also received 300 mg/m2 of cyclophosphamide on days 1,
8, 15 and 22 and prednisone at 100 mg every two days. Patients were treated
for up to eight cycles. Response was assessed by the European Group for
Blood and Marrow Transplant (EBMT) criteria. Results were presented by Dr.
Reece and showed an ORR (CR + partial response + minor response) of 93
percent, including a high CR rate of 54 percent. At one year, all patients
were alive (one-year survival rate). Therapy demonstrated excellent patient
tolerance with side effects similar to those seen with each agent alone.
Phase II Study of VELCADE, Lenalidomide and Dexamethasone in Relapsed /
Refractory Multiple Myeloma (Abstract #PO-660)
The Phase II multi-center study evaluated the efficacy and safety of
this novel combination therapy. The trial included 19 evaluable relapsed /
refractory MM patients, including those who had received prior VELCADE,
lenalidomide, thalidomide or stem cell transplantation. The patients
received VELCADE at 1.0 mg/m2 on days 1, 4, 8 and 11 of a 21-day schedule;
lenalidomide at 15 mg on days 1 through 14; and dexamethasone at 40 mg for
cycles one through four and 20 mg for cycles five through eight. Patients
received a median of five cycles. Responses were assessed using the EBMT
criteria. Results were presented by Paul Richardson, M.D., Dana-Farber
Cancer Institute, and showed a 68 percent ORR, including a CR rate of 5
percent. Therapy was well tolerated with no grade 3 or higher toxicities.
About Multiple Myeloma
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%) in single-agent VELCADE, 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.
(1) Complete remission / complete response includes both immunofixation
positive and negative readouts
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
Contacts:
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (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
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/114562.html /
CONTACT:
Media, Jennifer Snyder, +1-617-444-1439, or
Investors, Kyle Kuvalanka, +1-857-498-0818, both for Millennium
Pharmaceuticals, Inc.
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