Healthcare Industry News: Ortho Biotech
News Release - July 2, 2007
VELCADE(R) (bortezomib) for Injection Based Induction Therapy Delivered High Post-Transplant Complete Remission Rate, a Critical Marker for Increased Overall SurvivalNew Data from Phase III Intergroupe Francophone du Myelome (IFM) Trial Presented During IMW
CAMBRIDGE, Mass., July 2 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today reported that new data were presented on the comparative Phase III clinical trial evaluating a VELCADE based therapy in newly diagnosed multiple myeloma (MM) patients. As induction therapy prior to stem cell transplantation (SCT), the VELCADE based therapy produced a high complete remission / complete response(1) (CR) rate of 20 percent, which led to a post SCT CR rate of 43 percent. These results were substantially stronger than those of a commonly used induction chemotherapy regimen vincristine, adriamycin and dexamethasone (VAD), which served as the comparative therapy in the trial. The data showed that the VELCADE based therapy, compared to VAD, nearly doubled the CR rate as induction therapy and provided a greater than 50 percent improvement in CR rate following SCT. Achievement of CR is the goal of SCT therapy because achievement of CR increases both progression-free and overall survival. The data were presented in conjunction with the prestigious 11th International Myeloma Workshop (IMW) in Kos, Greece.
"Historically, stem cell transplantations generated similar response rates regardless of the induction therapy due to the limited efficacy of these therapies. With VELCADE, we now have a powerful agent that has consistently delivered high complete remission rates during induction and has allowed physicians to mobilize stem cells successfully. These benefits have translated to post-transplantation complete remission rates that are significantly higher than what has ever been achieved before," said Professor Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu. "We know that high complete remission rates following transplantation lead to longer progression-free survival and overall survival. These data position VELCADE as an important therapy for front-line patients."
The multi-center, randomized Phase III trial is being conducted by the IFM cooperative group. The trial was designed to compare VELCADE in combination with dexamethasone to VAD as induction therapy prior to SCT in 480 newly diagnosed MM patients. The presentation during IMW included new data from 161 patients who received induction therapy, of which 137 patients received SCT. Results presented by Dr. Harousseau showed:
* As induction therapy prior to SCT, the VELCADE based therapy showed a CR rate of 20 percent compared to 7 percent for VAD.
* Following SCT, the VELCADE based therapy demonstrated a CR rate of 43 percent and a very good partial response + CR (VGPR + CR) rate of 75 percent. VAD showed a CR rate of 28 percent and a VGPR + CR rate of 46 percent following SCT.
* The VELCADE based therapy was well tolerated; the most common adverse events included neurologic toxicities, fever/infection and neutropenia.
Patients on the VELCADE based therapy received four standard cycles of VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle. Patients also received dexamethasone at 40 mg on days 1 through 4 during cycles one through four and on days 9 through 12 during cycles one and two only. Patients on VAD were treated for four cycles with vincristine at 0.4 mg/m2 on days 1 through 4; adriamycin at 9 mg/m2 on days 1 through 4; and dexamethasone 40 mg on days 1 through 4, days 9 through 12 during cycles one through four and on days 17 through 20 during cycles one and two only. Some patients received consolidation therapy. Response was assessed by the European Group for Blood and Marrow Transplant criteria.
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® (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
Source: illennium Pharmaceuticals
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