Healthcare Industry News: Janssen
News Release - March 6, 2006
Millennium and Johnson & Johnson Pharmaceutical Research & Development Initiate Randomized Phase II Trial of VELCADE(R) (Bortezomib) for Injection in Non-Small Cell Lung CancerBuilding on positive single-agent activity, companies advance clinical development program
CAMBRIDGE, Mass., March 6 (HSMN NewsFeed) -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM ) today announced together with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), the initiation of a three-arm, randomized, Phase II study of VELCADE and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior chemotherapy treatment. The study will assess the potentially additive benefits of combining the activity of two targeted therapies with different mechanisms of action. Also already underway is a two-arm, randomized, Phase II study of VELCADE in combination with erlotinib for patients with locally advanced or metastatic NSCLC and a study of single-agent VELCADE in relapsed bronchioalveolar carcinoma and adenocarcinoma of the lung. In newly diagnosed patients with NSCLC, a study to evaluate VELCADE in combination with other agents has recently been completed.
"Based on promising, single-agent response rates, we are moving forward with our clinical program to evaluate the benefits of VELCADE based regimens in treating non-small cell lung cancer," said David Schenkein, M.D., Senior Vice President, Clinical Development. "We hope to demonstrate that these approaches may offer additional efficacy and safety benefits and may help patients with this advanced disease."
The Phase II randomized, open-label, multi-center study will enroll approximately 135 patients. The primary endpoint is objective response rate (complete and partial response) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary endpoints of the study include disease control rates (complete response, partial response and stable disease), time to progression, progression-free survival and safety. Patients will be assigned to one of three treatment groups: VELCADE in combination with pemetrexed, pemetrexed alone or VELCADE alone. VELCADE will be administered on a weekly schedule in both arms. The weekly dose of VELCADE in this study is 1.6 mg/m2 and pemetrexed will be administered at the standard registered dose of 500 mg/m2.
Previous clinical trial results of VELCADE in NSCLC include:
* Interim survival data from a Phase II study of VELCADE in combination with gemcitabine and carboplatin in newly diagnosed patients with NSCLC was recently provided by the Southwest Oncology Group. The analysis of the combination therapy showed a median five-month, progression-free survival and a median 11-month overall survival. The side effects observed in this trial were manageable and similar to those seen in other trials of VELCADE including gastrointestinal events, hematologic events, fatigue and peripheral neuropathy.
* Final data from the single-agent arm of a multi-center, Phase II trial of VELCADE in second-line NSCLC was presented in May 2005 at the 41st Annual Meeting of the American Society of Clinical Oncology. Data from the trial of VELCADE as a single agent showed a median survival of 7.4 months and a one-year survival of 39 percent. The most common adverse events in this trial were gastrointestinal events, fatigue and peripheral neuropathy.
About Non-Small Cell Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women in the United States. Approximately 163,500 deaths will be attributed to lung cancer and 172,570 new cases will be diagnosed in 2005. Of those, 87 percent will be NSCLC. There are three sub- types of NSCLC, including squamous cell carcinoma, adenocarcinoma, and large- cell undifferentiated carcinoma. The five-year survival rate for all stages of NSCLC combined is 15 percent. If NSCLC is diagnosed and treated early with surgery before spreading to the lymph nodes or other organs, the average five- year survival rate improves to 50 percent. However, it is estimated that only 15 percent of people with lung cancer are diagnosed at an early stage.(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 Pharmaceuticals K.K. is responsible for commercialization in Japan.
Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. are investigating VELCADE in both hematologic and solid tumors in trials throughout the U.S. and Europe. VELCADE currently is approved in more than 60 countries worldwide including the U.S., most of Europe, and a number of countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand.
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 http://www.millennium.com.
This press release contains "forward-looking statements," including statements about the Company's discovery 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) American Cancer Society, ''What is Lung Cancer?'' Available at http://www.cancer.org. Accessed on February 10, 2006.
Source: Millennium Pharmaceuticals
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