Healthcare Industry News: Ortho Biotech
News Release - December 11, 2006
Multiple Myeloma Patients Respond to Retreatment with VELCADE(R) (Bortezomib) for InjectionData show patients who received a first course of VELCADE therapy benefit from subsequent VELCADE based treatment
ORLANDO, Fla., Dec. 11 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced findings from two retrospective analyses evaluating VELCADE®(bortezomib) for Injection as retreatment therapy in heavily pretreated relapsed multiple myeloma (MM) patients. These data showed overall response rates (complete response [CR] and partial response [PR]) to retreatment as high as 60 percent among patients who had an initial response to VELCADE treatment and as high as 29 percent among patients who did not show a response to their initial VELCADE treatment. These data were presented at the American Society of Hematology (ASH) 48th Annual Meeting in Orlando, Fla., December 9-12, 2006 and show repeat use of VELCADE in relapsed MM patients can improve disease outcomes, including in patients who did not respond to their first treatment of VELCADE.
"Relapsed patients have limited treatment options as they often develop resistance to therapy, especially when treated to progression," said Dixie Esseltine, M.D., Vice President, Global Medical Affairs, Millennium. "These results showed that patients can receive VELCADE in multiple lines of therapy, with treatment-free intervals and potentially benefit from retreatment with VELCADE with an improved clinical response."
Utility of VELCADE (Bortezomib) Retreatment for Patients with Relapsed Multiple Myeloma (Abstract #3532)
The retrospective review of 22 patients primarily from the Phase II SUMMIT and CREST and Phase III APEX studies was designed to assess the efficacy and safety of VELCADE based therapy as retreatment. Patients had received a median of 3.5 therapies prior to their initial VELCADE based treatment. VELCADE was dosed at 1.3 mg/m2 on days 1, 4, 8 and 11 for a median of 7.5 three-week cycles. In response to initial VELCADE therapy, ORR was 68 percent. As retreatment, patients received VELCADE as a single agent or in combination for a median of 5.5 cycles following at least a 60-day treatment break. Patient response was determined using M-protein values. The study was presented by Jeffrey Wolf, M.D., Alta Bates Comprehensive Cancer Center, Berkeley, Calif., and showed:
* Of all patients in the analysis, ORR to retreatment was 50 percent
-- Of patients who initially responded to VELCADE, ORR to retreatment was 60 percent -- Of patients who did not initially respond to VELCADE, ORR to retreatment was 29 percent * Of responding patients who had a treatment-free interval of at least six months after their first treatment with VELCADE, the ORR was higher at 75 percent
* During retreatment two patients withdrew due to toxicities compared to three patients during initial treatment; no patients required dose reduction for peripheral neuropathy compared to four patients during initial treatment
An Observational, Retrospective Analysis of Retreatment with VELCADE (Bortezomib) of Multiple Myeloma Patients (Abstract #3531)
The retrospective analysis examined the efficacy and safety of VELCADE as retreatment in 95 MM patients who received at least two VELCADE based therapies. These patients were identified in the U.S. Oncology claims database. In response to initial therapy, 57 percent of patients achieved a PR or better. VELCADE was given as a single agent or in combination, and patients received a median of four and two VELCADE cycles during the first and second treatment, respectively. Median time between first and second VELCADE treatment was five months. The study was presented by Therese Conner, Outcomes Research, U.S. Oncology, Houston, Texas. Results showed:
* Of all patients in the analysis, ORR was 20 percent upon retreatment regardless of initial response
* Of patients who achieved a PR or better on initial therapy, 32 percent achieved at least a PR upon retreatment
* The most common adverse event was neuropathy; number of patients who stopped treatment due to toxicity was lower with retreatment compared to initial treatment
Data from the multicenter Phase IV EVEREST trial evaluating retreatment with VELCADE were presented at this year's European Society for Medical Oncology Conference. The ORR from this study was 39 percent.
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)
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).
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 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.
Editors' Note: This press release is also available under the Media section of the Company's website at: www.millennium.com.
(1) American Cancer Society, Overview: Multiple Myeloma, 2005, http://www.cancer.org
Source: Millennium Pharmaceuticals
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