ORLANDO, Fla., Dec. 10 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today reported that the Intergroupe Francophone du Myelome (IFM) cooperative group presented preliminary data from a Phase III clinical trial in newly diagnosed multiple myeloma (MM) patients treated with VELCADE(R) (bortezomib) for Injection in combination with dexamethasone as induction therapy prior to stem cell transplantation. Data showed that the VELCADE and dexamethasone combination achieved a complete and near complete response (CR/nCR) rate of 20 percent, greater than a two-fold improvement over the vincristine, adriamycin and dexamethasone triplet (VAD), a commonly used therapy in this treatment setting. The trial is part of a comprehensive registration-enabling Phase III program evaluating VELCADE in the treatment of newly diagnosed MM patients in the transplant and non- transplant settings. The preliminary results were reported at the 48th Annual Meeting and Exposition of the American Society of Hematology (ASH), December 9-12, 2006, in Orlando, Fla.
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"These preliminary data are the first to be reported from a randomized Phase III trial of VELCADE in newly diagnosed patients and represent an important step in building the evidence for the role of VELCADE in this treatment setting," said Jean-Luc Harousseau, M.D., of Hospital Hotel-Dieu, Nantes, France. "Achieving a high CR rate, as seen with VELCADE based induction therapy prior to stem cell transplantation, is important because it may lead to improved long-term outcomes for patients. We look forward to completing the trial."
VELCADE (Bortezomib) Dexamethasone Versus VAD as Induction Treatment Prior to Autologous Stem Cell Transplantation in Newly Diagnosed Multiple Myeloma: An Interim Analysis of the IFM 2005-01 Randomized, Multicenter Phase III Trial (Abstract # 56)
The multicenter, randomized Phase III clinical trial was designed to compare VELCADE in combination with dexamethasone to VAD as induction treatment prior to stem cell transplantation in 480 newly diagnosed MM patients. The preliminary analysis presented at the conference included data from the first 161 eligible patients enrolled in the trial. The 79 patients in the VELCADE and dexamethasone arm were treated for four 21-day cycles of VELCADE at its standard dose and schedule of 1.3 mg/m2 on days 1, 4, 8 and 11, with oral dexamethasone at 40 mg/m2 on days one through four and days nine through 12 for cycles one and two and on days one through four for cycles three and four. The 82 patients on the VAD arm received four 28-day cycles of vincristine at 0.4 mg/m2 continuous infusion on days one through four, adriamycin at 9 mg/m2 continuous infusion for days one through four and oral dexamethasone at 40 mg/m2 on days one through four, days nine through 12 and days 17 to 20 for cycles one and two, and on days one and four for cycles three and four. Data presented were investigator-assessed responses using modified European Group for Blood and Marrow Transplantation (EBMT) criteria. Results presented by Professor Harousseau included:
- VELCADE and dexamethasone showed a CR/nCR rate of 20 percent compared to
a nine percent rate for VAD
- VELCADE and dexamethasone showed a CR and very good partial response
(VGPR) rate of 43 percent compared to a 26 percent rate for VAD
- VELCADE and dexamethasone showed an overall response rate (CR and
partial response) of 82 percent compared to a 67 percent rate for VAD
- VELCADE and dexamethasone was well tolerated; the most common adverse
events were nausea, constipation and anemia
The IFM group continues to enroll patients to achieve the target of 480 patients. Response data for the interim analysis are being determined by an independent data review committee. An early filing opportunity may be possible in 2007.
VELCADE is the U.S. market leader in relapsed MM. Previous single-agent VELCADE studies in relapsed MM have demonstrated unprecedented survival. In newly diagnosed patients, VELCADE based therapies have achieved transplant- like results with overall response rates of up to 95 percent and CR/nCR rates of up to 43 percent. To date, over 50,000 MM patients have been treated with VELCADE worldwide.
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/
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