- Following recent FDA approval in previously treated mantle cell lymphoma,
new data on VELCADE presented at ASCO show potential in broader NHL patient
populations -
CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals,
Inc. (Nasdaq: MLNM) today announced positive data from clinical trials of
VELCADE in newly diagnosed non-Hodgkin's lymphoma (NHL) patients at the
43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago. These data showed that the addition of VELCADE to current
standards of care produced high complete response (CR) rates in patients
with newly diagnosed B-cell lymphoma (BCL) and mantle cell lymphoma (MCL).
(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )
B-cell Lymphoma
"B-cell lymphoma is the most prevalent form of NHL, which affects
approximately one million patients worldwide. Although current therapies
are effective for some, a number of patients still do not achieve adequate
response," said Nicolas Mounier, M.D., Ph.D., of Hopital Saint Louis. "This
study shows that the addition of VELCADE to R-CHOP, the current standard of
care, improved the complete response rate and overall survival compared to
historical data. These data warrant moving forward in a randomized trial to
show more definitively the additive benefit of VELCADE."
Efficacy and Toxicity of Two Schedules of R-CHOP Plus Bortezomib in
Front- Line B Lymphoma Patients: A Randomized Phase II Trial from the
Groupe d'Etude des Lymphomes de l'Adulte (Abstract #8010)
The Phase II study evaluated rituximab plus cyclophosphamide,
doxorubicin, vincristine and prednisone (R-CHOP) plus VELCADE in newly
diagnosed BCL patients. Results were presented by Dr. Mounier and showed:
-- Overall survival (OS) rate was 100 percent after a median follow-up of
12 months
-- Complete response and unconfirmed complete response (CR/CRu) rate was
83 percent, a superior result compared to the historical response for
R-CHOP given for six cycles, without VELCADE, which ranged from 55
percent to 75 percent
-- Grade 3 and 4 toxicities included neurological toxicities,
thrombocytopenia, leucopenia and infection
The trial included 48 evaluable patients. Patients received an average
of six cycles of standard R-CHOP and were randomized between two schedules
of VELCADE. Patients in arm A received VELCADE on days 1, 4, 8 and 11 and
in arm B on days 1 and 8. For the first 24 patients in both arms, VELCADE
was administered at 1 mg/m2 in arm A and 1.3 mg/m2 in arm B. For the next
24 patients, VELCADE was increased to 1.3 mg/m2 and 1.6 mg/m2,
respectively.
Mantle Cell Lymphoma
"Mantle cell lymphoma remains one of the most challenging forms of
lymphoma to treat. The data presented today suggest that VELCADE in
combination with a current standard of care may improve the complete
response rates, providing new hope for newly diagnosed mantle cell lymphoma
patients," said Brad Kahl, M.D., Assistant Professor, University of
Wisconsin. "As a result of these encouraging outcomes, the Eastern
Cooperative Oncology Group has initiated a larger study to further evaluate
the role of this VELCADE based therapy in these difficult-to-treat
patients."
A Feasibility Study of VcR-CVAD with Maintenance Rituximab for
Untreated Mantle Cell Lymphoma (Abstract #8062)
The Phase II pilot study evaluated VcR-CVAD (VELCADE, rituximab,
cyclophosphamide, vincristine, doxorubicin, and dexamethasone) as initial
therapy with rituximab consolidation and maintenance in newly diagnosed MCL
patients. Results from the trial conducted by Dr. Kahl showed:
-- Overall response rate was 88 percent with 82 percent of patients
achieving a CR/CRu
-- After 12 months follow-up, median OS and progression-free survival had
not yet been reached
-- Grade 3 and 4 toxicities included peripheral neuropathy,
thrombocytopenia and neutropenia
The encouraging response rates noted in this study provide the basis
for the Eastern Cooperative Oncology Group protocol 1405, which will test
the regimen with VELCADE 1.3 mg/m2 and vincristine 1.0 mg in a cooperative
group setting.
The study included 17 evaluable patients. In the initial study design,
patients received VELCADE at either 1.5 mg/m2 or 1.3 mg/m2 on days 1 and 4,
rituximab 375 mg/m2 IV on day 1, cyclophosphamide 300 mg/m2 IV for three
hours twice a day with six doses on days 1 through 3, doxorubicin 50 mg/m2
via continuous infusion over 48 hours on days 1 and 2, vincristine 2 mg IV
on day 3 and dexamethasone 40 mg once a day on days 1 through 4. To manage
the peripheral neuropathy, VELCADE and vincristine doses were reduced to
1.3 mg/m2 and 1 mg respectively. Patients received the regimen every 21
days for six cycles with Granulocyte Colony-Stimulating Factor (G-CSF)
cytokine support.
About Non-Hodgkin's Lymphoma (NHL) and Mantle Cell Lymphoma (MCL)
NHL is the most common hematological cancer, the fifth leading cause of
cancer death and the second fastest-growing form of cancer in the U.S. The
prevalence of NHL in the U.S. is approximately 400,000 patients, including
approximately 200,000 patients with diffuse large B-cell lymphoma, 100,000
patients with follicular and marginal zone lymphoma and 10,000 with MCL.
There are approximately 54,000 new cases of NHL diagnosed in the U.S. per
year, and 19,000 deaths are attributed to the disease annually.
MCL is an aggressive, rapidly progressive subtype of NHL and is not
curable with standard treatment. The median life expectancy for a patient
with MCL following first relapse is one to two years.
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.
 back to top
Related links:
http://www.millennium.com/
Photo Notes:http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Media, Jennifer Snyder, +1-617-448-0281, or
Investors, Kyle Kuvalanka, or +1-857-498-0818, both for
Millennium Pharmaceuticals, Inc.
|
