- Single-agent data demonstrate six-month survival advantage over dexamethasone -
ATLANTA, Dec. 11 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced extended survival data from the international, multi-center phase III APEX trial, the largest randomized study in relapsed myeloma, and the only trial to demonstrate a survival advantage for a single agent, VELCADE, in this setting. The results demonstrate a six-month survival advantage for patients in the VELCADE arm. VELCADE demonstrated a median overall survival of 30 months. These findings were presented at the 47th Annual Meeting of the American Society of Hematology being held December 10-13, 2005 in Atlanta, GA.
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"The survival benefit observed with VELCADE is a real milestone in a patient population for whom resistance to treatment and shortened survival constitutes a major challenge," said Paul Richardson, M.D., Dana-Farber Cancer Institute in Boston and the lead investigator for the APEX trial. "The results support a number of clinical studies already underway to assess the potential of VELCADE as an initial therapy."
The updated results, based on median follow-up of 22 months, from the APEX study continue to show VELCADE is superior to high-dose dexamethasone in overall survival and one-year survival rates, response rates and time to progression. The APEX trial was conducted at 93 centers in North America, Europe and Israel and enrolled 669 patients with multiple myeloma who had received one to three prior therapies.
"These data build upon the impressive track record established by the eight-cycle VELCADE regimen in the phase II trials on which it was initially approved," David Schenkein, M.D., senior vice president, clinical development, Millennium. "VELCADE is delivering on the promise to change the course of disease for myeloma patients."
About Multiple Myeloma (MM)
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 United States, more than 45,000 to 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 due to MM each year(1).
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 disorders, gastrointestinal adverse events, thrombocytopenia 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%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%), anorexia and appetite decreased (34%), parasthesia (27%), dysesthesia (27%), anemia and headache (26%), and cough (21%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%), and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea, pneumonia (4%), and vomiting (3%).
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 60 countries worldwide. VELCADE is also approved in the European Union as a second-line treatment.
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).
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, its understanding of disease mechanisms and its industrialized drug discovery platform, Millennium is seeking to develop breakthrough products. 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.
Editor's Note: Abstracts can be accessed on the ASH website at http://www.hematology.org/ and were published in the November 16, 2005 issue of BLOOD, the journal of the American Society of Hematology.
Also, this release is available under the Media section on the Company's website at http://www.millennium.com/.
CONTACT: Media: Theresa McNeely, +1-617-679-7405, Investors: Kyle Kuvalanka, +1-617-761-4734, both for Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/ http://www.hematology.org/
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