Velcade (Bortezomib) for Injection Based Therapies Produced Complete Remission Rates as High as 54 Percent in Patients With Previously Treated Multiple Myeloma
KOS, Greece, June 28, 2007 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today reported on the presentation of results from clinical trials of VELCADE based therapies that showed high complete remission / complete response(1) (CR) rates in previously treated multiple myeloma (MM) patients. These findings were presented at the prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece. Highlights included:
-- VELCADE, cyclophosphamide and prednisone (VCP) demonstrated an overall response rate (ORR) of 93 percent including a CR(1) rate of 54 percent. At one year, 100 percent of patients were alive. -- VELCADE, lenalidomide and dexamethasone (VRD) showed an ORR of 68 percent with a 5 percent CR(1) rate in a pilot study of heavily pretreated patients, including those who had been previously treated with VELCADE or lenalidomide.
"By combining the power of VELCADE with other active agents, we are seeing some of the strongest reported efficacy in previously treated multiple myeloma patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The wealth of combination data that are being generated promises to strengthen the U.S. market-leading role of VELCADE."
Weekly VELCADE, Cyclophosphamide and Prednisone in Myeloma (Abstract #PO- 639)
"VELCADE has shown synergistic activity with alkylating agents by generating substantially high and durable complete remission rates," said Donna Reece, M.D., Princess Margaret Hospital. "This is an important finding for the field of multiple myeloma and leads us to believe that the combination of VELCADE and cyclophosphamide warrants further investigation in the front-line setting with the goal of prolonging patients' survival."
The Phase II study was designed to evaluate the efficacy and safety of VCP in relapsed / refractory MM patients. The study included 13 evaluable patients, who received VELCADE at 1.5 mg/m2 on days 1, 8 and 15 of a 28-day schedule. Patients also received 300 mg/m2 of cyclophosphamide on days 1, 8, 15 and 22 and prednisone at 100 mg every two days. Patients were treated for up to eight cycles. Response was assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria. Results were presented by Dr. Reece and showed an ORR (CR + partial response + minor response) of 93 percent, including a high CR rate of 54 percent. At one year, all patients were alive (one-year survival rate). Therapy demonstrated excellent patient tolerance with side effects similar to those seen with each agent alone.
Phase II Study of VELCADE, Lenalidomide and Dexamethasone in Relapsed / Refractory Multiple Myeloma (Abstract #PO-660)
The Phase II multi-center study evaluated the efficacy and safety of this novel combination therapy. The trial included 19 evaluable relapsed / refractory MM patients, including those who had received prior VELCADE, lenalidomide, thalidomide or stem cell transplantation. The patients received VELCADE at 1.0 mg/m2 on days 1, 4, 8 and 11 of a 21-day schedule; lenalidomide at 15 mg on days 1 through 14; and dexamethasone at 40 mg for cycles one through four and 20 mg for cycles five through eight. Patients received a median of five cycles. Responses were assessed using the EBMT criteria. Results were presented by Paul Richardson, M.D., Dana-Farber Cancer Institute, and showed a 68 percent ORR, including a CR rate of 5 percent. Therapy was well tolerated with no grade 3 or higher toxicities.
About Multiple Myeloma
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.
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%) in single-agent VELCADE, 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).
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 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.
(1) Complete remission / complete response includes both immunofixation
positive and negative readouts
Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com.
Jennifer Snyder (media) Kyle Kuvalanka (investors)
(617) 444-1439 (857) 498-0818
CONTACT: Media, Jennifer Snyder, +1-617-444-1439, or Investors, KyleKuvalanka, +1-857-498-0818, both for Millennium Pharmaceuticals, Inc.
Web site: http://www.millennium.com/
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Ticker Symbol: (NASDAQ-NMS:MLNM)
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Posted: June 2007