- Data show patients who received a first course of VELCADE therapy benefit
from subsequent VELCADE based treatment -
ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Millennium
Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced findings from two
retrospective analyses evaluating VELCADE(R)(bortezomib) for Injection as
retreatment therapy in heavily pretreated relapsed multiple myeloma (MM)
patients. These data showed overall response rates (complete response [CR]
and partial response [PR]) to retreatment as high as 60 percent among
patients who had an initial response to VELCADE treatment and as high as 29
percent among patients who did not show a response to their initial VELCADE
treatment. These data were presented at the American Society of Hematology
(ASH) 48th Annual Meeting in Orlando, Fla., December 9-12, 2006 and show
repeat use of VELCADE in relapsed MM patients can improve disease outcomes,
including in patients who did not respond to their first treatment of
VELCADE.
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
"Relapsed patients have limited treatment options as they often develop
resistance to therapy, especially when treated to progression," said Dixie
Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. "These
results showed that patients can receive VELCADE in multiple lines of
therapy, with treatment-free intervals and potentially benefit from
retreatment with VELCADE with an improved clinical response."
Utility of VELCADE (Bortezomib) Retreatment for Patients with Relapsed
Multiple Myeloma (Abstract #3532)
The retrospective review of 22 patients primarily from the Phase II
SUMMIT and CREST and Phase III APEX studies was designed to assess the
efficacy and safety of VELCADE based therapy as retreatment. Patients had
received a median of 3.5 therapies prior to their initial VELCADE based
treatment. VELCADE was dosed at 1.3 mg/m2 on days 1, 4, 8 and 11 for a
median of 7.5 three-week cycles. In response to initial VELCADE therapy,
ORR was 68 percent. As retreatment, patients received VELCADE as a single
agent or in combination for a median of 5.5 cycles following at least a
60-day treatment break. Patient response was determined using M-protein
values. The study was presented by Jeffrey Wolf, M.D., Alta Bates
Comprehensive Cancer Center, Berkeley, Calif., and showed:
* Of all patients in the analysis, ORR to retreatment was 50 percent
-- Of patients who initially responded to VELCADE, ORR to retreatment
was 60 percent
-- Of patients who did not initially respond to VELCADE, ORR to
retreatment was 29 percent
* Of responding patients who had a treatment-free interval of at least
six months after their first treatment with VELCADE, the ORR was higher
at 75 percent
* During retreatment two patients withdrew due to toxicities
compared to three patients during initial treatment; no patients
required dose reduction for peripheral neuropathy compared to four
patients during initial treatment
An Observational, Retrospective Analysis of Retreatment with VELCADE
(Bortezomib) of Multiple Myeloma Patients (Abstract #3531)
The retrospective analysis examined the efficacy and safety of VELCADE
as retreatment in 95 MM patients who received at least two VELCADE based
therapies. These patients were identified in the U.S. Oncology claims
database. In response to initial therapy, 57 percent of patients achieved a
PR or better. VELCADE was given as a single agent or in combination, and
patients received a median of four and two VELCADE cycles during the first
and second treatment, respectively. Median time between first and second
VELCADE treatment was five months. The study was presented by Therese
Conner, Outcomes Research, U.S. Oncology, Houston, Texas. Results showed:
* Of all patients in the analysis, ORR was 20 percent upon retreatment
regardless of initial response
* Of patients who achieved a PR or better on initial therapy, 32 percent
achieved at least a PR upon retreatment
* The most common adverse event was neuropathy; number of patients who
stopped treatment due to toxicity was lower with retreatment compared to
initial treatment
Data from the multicenter Phase IV EVEREST trial evaluating retreatment
with VELCADE were presented at this year's European Society for Medical
Oncology Conference. The ORR from this study was 39 percent.
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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NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
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PRN Photo Desk, photodesk@prnewswire.com
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CONTACT:
Media, Jennifer Snyder, +1-617-448-0281, or
Investors, Kyle Kuvalanka, +1-857-498-0818, both of Millennium
Pharmaceuticals, Inc.
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