Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that the Journal of
Clinical Oncology has published the final results of the PINNACLE trial,
one of the largest multi-center studies ever done in the setting of
relapsed mantle cell lymphoma (MCL). The results demonstrate the potential
of VELCADE as treatment for relapsed MCL, an aggressive form of
non-Hodgkin's lymphoma (NHL). The study, which provided the major source of
data for the sNDA filing for VELCADE in relapsed MCL, was prepublished
online in the September 25, 2006 Journal of Clinical Oncology and will run
in the October 20, 2006 print issue. VELCADE for relapsed MCL is under
Priority Review with the U.S. Food and Drug Administration (FDA) and a
decision is expected by December 9, 2006.
"The publication in Journal of Clinical Oncology highlights the
potential of VELCADE in the treatment of mantle cell lymphoma," said
Deborah Dunsire, M.D., President and CEO, Millennium. "The study, one of
several Phase II trials which consistently showed impressive response rates
and duration of response, suggests that VELCADE may become a standard
component of therapy in this disease."
Results of the study, which was undertaken with Millennium's
co-development partner, Johnson & Johnson Pharmaceutical Research &
Development, L.L.C. (J&JPRD), showed a 33 percent overall response rate and
an 8 percent complete response rate. Importantly, the median overall
duration of response was 9.2 months, and 13.5 months in patients who
achieved a complete response. These results are consistent with those of
four investigator-initiated Phase II clinical trials where overall response
rates of 30 to 40 percent with single-agent VELCADE were observed.
PINNACLE Study
In this prospective, single-arm study, 155 patients with relapsed or
refractory MCL who had received a maximum of two prior therapies, received
single-agent VELCADE 1.3mg/m2 twice weekly for two weeks every 21 days for
up to one year. Patients achieving complete response, unconfirmed complete
response or partial response received a median of 8 treatment cycles, and
all patients in the study received a median of 4 cycles. Study results
included:
-- Overall response rate of 33 percent
-- Complete response rate of 8 percent
-- Median duration of response of 9.2 months; 13.5 months in patients
achieving a complete response
-- Median time to progression of 6.2 months
-- Median treatment-free interval of 13.8 months in patients achieving a
complete response
-- Treatment was well tolerated. The most common non-hematologic adverse
events were fatigue, gastrointestinal events and peripheral neuropathy.
Hematologic toxicities were consistent with those previously seen with
VELCADE.
VELCADE currently is approved in the United States for the treatment of
multiple myeloma (MM) patients who have received at least one prior
therapy. To date, over 44,000 MM patients have been treated with VELCADE
for MM worldwide, including clinical trials. Earlier this year, Millennium
and co-development partner, J&JPRD, initiated a Phase III clinical trial
with VELCADE in combination with rituximab in patients with relapsed or
refractory follicular and marginal zone lymphoma.
About Non-Hodgkin's Lymphoma and Mantle Cell Lymphoma
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.(1)
The prevalence of NHL is approximately 400,000 patients, 77,000 patients
with follicular lymphoma and 10,000 with mantle cell lymphoma. There are
approximately 54,000 new cases of NHL diagnosed per year, and 19,000 deaths
are attributed to the disease annually(2,3).
MCL is an aggressive, rapidly progressive subtype of NHL, and is not
curable with standard treatment. Because there is no generally accepted
treatment approach and options are often limited, there is a growing need
for new therapies. The average life expectancy for a patient with relapsed
MCL is one to two years.
About VELCADE
VELCADE is indicated for the treatment of multiple myeloma patients 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.
In 331 patients who were treated with VELCADE in a Phase III study, the
most commonly reported adverse events were asthenic conditions (61
percent), diarrhea (57 percent), nausea (57 percent), constipation (42
percent), peripheral neuropathy (36 percent), vomiting (35 percent),
pyrexia (35 percent), thrombocytopenia (35 percent), psychiatric disorders
(35 percent), anorexia and appetite decreased (34 percent), parasthesia (27
percent), dysesthesia (27 percent), anemia and headache (26 percent), and
cough (21 percent). Fourteen percent of patients reported at least one
episode of grade 4 toxicity; the most common grade 4 toxicities were
thrombocytopenia (4 percent), neutropenia (2 percent), and hypercalcemia (2
percent). A total of 144 patients on VELCADE (44 percent) reported serious
adverse events (SAEs) during the study. The most commonly reported SAEs
were pyrexia (6 percent), diarrhea (5 percent), dyspnea and pneumonia (4
percent), and vomiting (3 percent).
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.
VELCADE is approved in more than 75 countries worldwide. VELCADE also is
approved in the European Union at first relapse.
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
millennium.
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.
This press release is also available under the Media
section of the Company's website at: millennium.
1. 2005, American Cancer Society, Inc., Surveillance Research.
2. SEER, SARGA, and Decision Resources (for growth rate) data.
3. Federico et al., BLOOD 95(3): 783-789; 2000.
Millennium Pharmaceuticals, Inc
millennium
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