CAMBRIDGE, Mass., Nov. 18 /PRNewswire/ -- Millennium: The Takeda Oncology
Company today announced that 120 data presentations concerning VELCADE
research will be featured at the 50th American Society of Hematology (ASH)
Annual Meeting in San Francisco, California, December 5-9, 2008. These
presentations will include the results on overall survival and efficacy of
VELCADE based therapies in patients with previously untreated multiple myeloma
(MM). Additional data will be presented on VELCADE based therapies in patients
with relapsed MM and non-Hodgkin's lymphoma (NHL).
(Logo: http://www.newscom.com/cgi-bin/prnh/20080827/NEW076LOGO )
"The volume of data on VELCADE, especially in the MM front-line setting
demonstrates an exciting and growing interest from the hematology community,"
said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "These data
provide further evidence for the longer term benefit of VELCADE multi-drug
combinations and for potential of VELCADE in combination with novel agents."
Previously Untreated Multiple Myeloma
Presentations at ASH will include data focusing on the use of VELCADE in
previously untreated multiple myeloma. Abstracts are scheduled to highlight
efficacy and overall survival data for VELCADE based therapies. Notable oral
presentations will include seven Phase III clinical trials and seven Phase
I/II studies, including:
-- Updated Follow-up and Results of Subsequent Therapy in the Phase III
VISTA trial: Bortezomib Plus Melphalan-Prednisone Versus Melphalan-Prednisone
in Newly Diagnosed Multiple Myeloma
-- Lead investigator: Jesus San-Miguel, M.D., Ph.D., Hospital
Universitario de Salamanca
-- Abstract #650: Oral presentation session: Monday, December 8,
3:45 PM
-- Superior Complete Response Rate and Progression-Free survival after
Autologous Transplantation with Up Front Velcade-Thalidomide-Dexamethasone
Compared with Thalidomide-Dexamethasone in Newly Diagnosed Multiple Myeloma
-- Lead investigator: Michele Cavo, University of Bologna, Bologna,
Italy
-- Abstract #158: Oral presentation session: Monday, December 8,
7:15 AM
-- VELCADE Dexamethasone (Vc/D) versus VAD as Induction Treatment Prior to
Autologous Stem Cell Transplantation (ASCT) in Previously Untreated Multiple
Myeloma: Updated Data from IFM 2005/01 Trial
-- Lead investigator: Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu,
Nantes, France
-- Oral presentation, ASH/ASCO Joint Symposium: Sunday, December 7,
9:30 AM
-- Safety and Efficacy of Novel Combination Therapy with Bortezomib,
Dexamethasone, Cyclophosphamide, and Lenalidomide in Newly Diagnosed Multiple
Myeloma: Initial Results from the Phase I/II Multi-Center EVOLUTION Study
-- Lead investigator: Shaji Kumar, M.D., Mayo Clinic, Rochester, MN
-- Abstract #93: Oral presentation session: Sunday, December 7,
5:00 PM
Relapsed Multiple Myeloma
Data will be presented from 27 studies of VELCADE based therapies for
patients with relapsed MM. These data include results from VELCADE use in the
retreatment setting as well as evaluation of improvement in clinical responses
after treatment with other regimens.
-- Phase I/II Results of a Multicenter Trial of Perifosine (KRX-0401) +
Bortezomib in Patients with Relapsed or Relapsed / Refractory Multiple Myeloma
Who Were Previously Relapsed from or Refractory to Bortezomib
-- Lead investigator: Paul Richardson, M.D., Dana-Farber Cancer
Institute, Boston, MA
-- Abstract #870: Oral presentation session: Tuesday, December 9,
8:30 AM
-- Efficacy and Safety of Re-Treatment with Bortezomib (VELCADE) in
Patients with Multiple Myeloma: Results from a Prospective International
Phase II Trial
-- Lead investigator: Maria T. Petrucci, Universita La Sapienza, Rome,
Italy
-- Abstract #3690: Poster session: Monday, December 8
-- Vorinostat Plus Bortezomib for the Treatment of Relapsed/Refractory
Multiple Myeloma: Early Clinical Experience
-- Lead investigator: Donna Weber, M.D., M.D. Anderson Cancer Center,
Houston, TX
-- Abstract #871: Oral presentation session: Tuesday, December 9,
8:45 AM
-- Preliminary Results of CNTO 328, An Anti-Interleukin-6 Monoclonal
Antibody, in Combination with Bortezomib in the Treatment of Relapsed or
Refractory Multiple Myeloma
-- Lead investigator: Jean-Francois Rossi, M.D., Ph.D., CHU
Montpellier, CIC BT509 and INSERM U475, Montpellier, France
-- Abstract #867: Oral presentation session: Tuesday, December 9,
7:45 AM
Non-Hodgkin's Lymphoma
Beyond multiple myeloma, Millennium continues to pursue and support trials
of VELCADE in NHL. Currently, VELCADE is the only approved therapy for
patients with mantle cell lymphoma (MCL) who have received at least one prior
therapy. Data will be featured for VELCADE in combination with established
agents in patients with untreated MCL as well as in untreated and relapsed
indolent NHL, including:
-- VcR-CVAD Produces a High Complete Response Rate in Untreated Mantle
Cell Lymphoma: A Phase II Study from the Wisconsin Oncology Network
-- Lead investigator: Brad S. Kahl, M.D., University of Wisconsin,
Madison, WI
-- Abstract #265: Oral presentation session: Monday, December 8,
8:00 AM
-- A Phase II Study of Combination Bortezomib (VELCADE) and Rituximab for
Untreated "High Tumor Burden" Indolent Non-Hodgkin's Lymphoma
-- Lead investigator: Kevin A. David, M.D., Robert H. Lurie
Comprehensive Cancer Center of Northwestern University, Chicago, IL
-- Abstract #2004, Poster session: Sunday, December 7
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy and
although the disease is predominantly a cancer of the elderly (the median age
of onset is 70 years), 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 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 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 87 countries worldwide.
Important Safety Information
In the U.S., VELCADE is indicated for the treatment of patients with
multiple myeloma. VELCADE also 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.
Risks associated with VELCADE therapy include new or worsening peripheral
neuropathy, hypotension throughout therapy, cardiac and pulmonary disorders,
reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse
events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic
events. Women of childbearing potential should avoid becoming pregnant while
being treated with VELCADE. Nursing mothers are advised not to breastfeed
while receiving 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 new onset of decreased left
ventricular ejection fraction has been reported, including reports in patients
with no risk factors for decreased left ventricular ejection fraction. There
have been 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. There have been reports of Reversible Posterior
Leukoencephalopathy Syndrome (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. Cases of acute liver failure have been reported in patients
receiving multiple concomitant medications and with serious underlying medical
conditions. Patients who are concomitantly receiving VELCADE and drugs that
are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored
for either toxicities or reduced efficacy. Patients on oral antidiabetic
medication while receiving VELCADE should check blood sugar levels frequently.
Adverse Reaction Data
Safety data from Phase II and III studies of single-agent VELCADE 1.3
mg/m(2)/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163
patients with previously treated multiple myeloma (N=1008, not including the
Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome injection] study)
and previously treated mantle cell lymphoma (N=155) were integrated and
tabulated. In these studies, the safety profile of VELCADE was similar in
patients with multiple myeloma and mantle cell lymphoma.
In the integrated analysis, the most commonly reported adverse events were
asthenic conditions (including fatigue, malaise and weakness) (64%), nausea
(55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC
(including peripheral sensory neuropathy and peripheral neuropathy aggravated)
(39%), thrombocytopenia and appetite decreased (including anorexia) (each
36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache,
paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and
insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness
(excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%),
bone pain (14%), back pain and hypotension (each 13%), herpes zoster,
nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia
(each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%).
Twenty percent (20%) of patients experienced at least 1 episode of greater
than or equal to Grade 4 toxicity, most commonly thrombocytopenia (5%) and
neutropenia (3%). A total of 50% of patients experienced serious adverse
events (SAEs) during the studies. The most commonly reported SAEs included
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: The Takeda Oncology Company, 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 Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company
Ltd. in May, 2008. The Company's research, development and commercialization
activities are focused in oncology. Additional information about Millennium is
available through its website, http://www.millennium.com.
Editors' Note: This press release is also available under the Media
section of the Company's website at: http://www.millennium.com.
Contacts:
Manisha Pai Karen Gobler
(617) 551-7877 (617) 444-1392
Manisha.Pai@mpi.com Karen.Gobler@mpi.com
