CHICAGO, June 3 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today reported on results presented by the University of Arkansas for Medical Sciences and the Center for Cancer Research and Biostatistics on Total Therapy 3 (TT3). TT3, a treatment for newly diagnosed multiple myeloma patients, includes a VELCADE based therapy prior to and as maintenance following stem cell transplantation. These results showed a significant improvement over previously reported results from Total Therapy 2 (TT2), a current standard of care, which did not include VELCADE. The data were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
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"The inclusion of VELCADE in Total Therapy treatment substantially improves long-term patient outcomes and further supports VELCADE as an important therapy in the front-line treatment setting," said Bart Barlogie, M.D., Ph.D., Director, Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences. "While TT2 was successful, the VELCADE based combination achieved superior, statistically significant improvement in event- free survival and complete response rates."
Phase II Study of Total Therapy 3 (TT3) with Added Bortezomib (V) for Multiple Myeloma (MM) (Abstract #8020)
Dr. Barlogie presented results of this Phase II study in TT3 at two-year follow-up. Data showed:
-- A complete response (CR) and near complete response (nCR) rate of 84
percent with TT3, a statistically significant improvement over TT2 at
68 percent
-- An event-free survival of 83 percent with TT3, a statistically
significant improvement over TT2 at 75 percent
-- A strong trend for improved overall survival in high-risk patients
under the age of 65 for TT3 compared to TT2
-- Fewer patients on TT3, compared to TT2, experienced grade 3 and 4 side
effects including tremor, constipation, syncope and thromboembolic
events
The study included 303 patients. Patients received two cycles of a combination called VTD-PACE (VELCADE, thalidomide, dexamethasone, cisplatin, adriamycin, cyclophosphamide and etoposide) as induction therapy prior to and as consolidation therapy following stem cell transplantation. Patients were then given a combination of VTD (VELCADE, thalidomide and dexamethasone) once monthly for one year and a combination of TD (thalidomide and dexamethasone) once monthly for two additional years. The TT2 trial, presented at ASCO 2005, included 323 patients who received the same therapy without VELCADE.
About Multiple Myeloma (MM)
Multiple myeloma 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 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
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.
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