CAMBRIDGE, Mass. - (Business Wire) Millennium: The Takeda Oncology Company today announced nearly 200 abstracts have been accepted for presentation at the annual meeting of the American Society of Hematology (ASH) being held December 5–8, 2009 in New Orleans, Louisiana. These abstracts include an oral presentation of data on successful VELCADE utilization in both induction and maintenance in the front-line setting during the distinguished plenary session being held on Sunday, December 6. The ASH Program Committee selects for the plenary session the most ground-breaking abstracts of the conference. Other key abstracts to be highlighted during the meeting include data on VELCADE as a foundation of therapy for a broad spectrum of patients with multiple myeloma (MM); an update on the survival benefit of VELCADE in the front line setting; the cost-effectiveness of VELCADE treatment for patients with MM; and VELCADE in patients with non-Hodgkin’s lymphoma (NHL). “We are excited by the breadth of ongoing research being presented at this year’s ASH meeting examining the efficacy, safety and cost-effectiveness of VELCADE in a range of disease settings,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium. “The number and quality of abstracts further demonstrate the level of scientific interest in VELCADE based therapy as a foundation treatment for patients with multiple myeloma, as well as its emergence in multiple myeloma maintenance.”
Previously Untreated Multiple Myeloma
Presentations at ASH will include data focusing on the use of VELCADE as a foundation of therapy in a broad range of patients. Scheduled presentations of VELCADE based therapies will highlight the long-term overall survival efficacy data, based on the longest overall survival follow-up in the front-line MM setting, as well as the efficacy results of VELCADE use in the maintenance setting. Notable presentations will include:
- A prospective, multicenter, randomized trial of Bortezomib/Melphalan/Prednisone (VMP) versus Bortezomib/Thalidomide/Prednisone (VTP) as induction therapy followed by maintenance treatment with Bortezomib/Thalidomide (VT) versus Bortezomib/Prednisone (VP) in elderly untreated patients with Multiple Myeloma older than 65 years
- Presenter: Maria-Victoria Mateos, M.D., Ph.D., Hospital Universitario de Salamanca, Salamanca, Spain
- Abstract #3 Oral Plenary session: Sunday, December 6, 2:30 pm
- Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Followed by Maintenance with Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients
- Presenter: Antonio Palumbo, M.D., Italian Multiple Myeloma Study Group
- Abstract #128 Oral presentation session: Sunday, December 6, 4:45 p.m.
- Bortezomib plus melphalan-prednisone continues to demonstrate a survival benefit vs melphalan-prednisone in the phase III VISTA trial in previously untreated multiple myeloma after more than 3 years’ follow-up and extensive subsequent therapy use
- Presenter: Maria-Victoria Mateos, M.D., Ph.D., Hospital Universitario de Salamanca, Salamanca, Spain
- Abstract #3859 Poster presentation session: Monday, December 7, 6:00 pm
Non-Hodgkin’s Lymphoma
Beyond multiple myeloma, Millennium continues to pursue and support trials of VELCADE in NHL. Currently, VELCADE is the only FDA-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 follicular lymphoma, including:
- Bortezomib, Bendamustine, and Rituximab in Patients with Relapsed or Refractory Follicular Lymphoma: Encouraging Activity in the Phase 2 VERTICAL Study
- Presenter: Nathan Fowler, M.D., MD Anderson Cancer Center, Houston, Texas
- Abstract #933 Oral presentation session: Tuesday, December 8, 8:00 am
- The VcR-CVAD Regimen Produces a High Complete Response Rate in Untreated Mantle Cell Lymphoma (MCL): First Analysis of E1405 – A Phase II Study of VcR-CVAD with Maintenance Rituximab for MCL
- Presenter: Brad S. Kahl, M.D., University of Wisconsin School of Medicine and Public Health, Madison, WI
- Abstract #1661 Poster presentation session: Saturday, December 5, 5:30 p.m.
Health Economics
The impact of cancer therapy cost and the accessibility of treatment are currently at the center of the debate on healthcare reform. Several abstracts at this year’s ASH address the cost and convenience of VELCADE based therapy compared with oral MM therapy options. These presentations include:
- Multiple Myeloma: Patient out-of-Pocket Costs and Health Care Utilization
- Presenter: Brett Pinsky, i3 Innovus, Eden Prairie, Minnesota
- Abstract #1366 Poster presentation session: Saturday, December 5, 5:30 pm
- The Cost-Effectiveness of Bortezomib for the Initial Treatment of Multiple Myeloma in the United States
- Presenter: Si-Tien Wang, Analysis Group, Inc., Boston, Massachusetts
- Abstract #1379 Poster presentation session: Saturday, December 5, 5:30 pm
About Millennium
Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a first-in-class proteasome inhibitor, 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, www.millennium.com.
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/m2/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® [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 ≥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).
Editors’ Note: This press release is also available under the Media section of the Company’s website at: www.millennium.com
Millennium: The Takeda Oncology Company
Manisha Pai, 617-551-7877
Manisha.Pai@mpi.com
or
Lauren Musto, 617-551-7848
Lauren.Musto@mpi.com
