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VELCADE(R) (Bortezomib) for Injection


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Addition of VELCADE® (Bortezomib) for Injection Improved survival in Front-Line Advanced Lung Cancer

Sunday June 4, 3:35 pm ET

-- 11-month Survival Compared to 9-Month Historic Results with a Standard of Care --

ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced the final results from a Phase II study conducted by the Southwest Oncology Group (SWOG) that showed a median survival of 11 months for patients with non-small cell lung cancer (NSCLC) treated with a VELCADE based regimen. This compared favorably to the historic 9-month survival seen in past SWOG studies with a 2-drug platin-based regimen, a current standard of care, in patients with non-small cell lung cancer (NSCLC). These data were reported at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, June 2-6, 2006.


(Logo: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGO )

"These survival results are among the best our group has seen in this newly diagnosed patient population," said Angela Davies, M.D., Assistant Professor, University of California Davis Cancer Center. "Given the current lack of options for treating lung cancer, we look forward to additional studies which may support the use of bortezomib."

VELCADE in Combination in Advanced NSCLC: A SWOG Phase II Trial (Abstract 7017)

The Phase II single-arm, multi-institutional study led by Dr. Davies assessed the safety and efficacy of VELCADE in combination with gemcitabine (GEM) and carboplatin (CARBO) in 114 chemo-naïve patients with stage IV and selected stage IIIB NSCLC. Patients received GEM 1000 mg/m2 days 1 and 8, and CARBO AUC 5 on day 1, followed one hour later by VELCADE 1.0mg/m2 days 1, 4, 8 and 11. Patients without disease progression after four cycles were able to continue with VELCADE alone. Response rate was measured using the RECIST (Response Evaluation Criteria in Solid Tumors) guidelines. Median follow up was 13 months. Key findings include:

-- Median overall survival of 11 months

-- One-year survival of 47 percent with five-month progression-free


-- Overall response rate of 20 percent; stable disease of 66 percent

-- Therapy well tolerated. The most common hematological toxicities were

neutropenia and thrombocytopenia and the most common non-hematological

adverse events were fatigue and gastrointestinal events.

NSCLC accounts for about 85 percent of all lung cancer cases(1) with an estimated prevalence of more than 170,000 new cases per year.(2) Drug choices are limited while resistance to standard treatments is common. Nearly 60 percent of those diagnosed with advanced lung cancer die within one year of diagnosis and only 15 percent of patients diagnosed with all stages of lung cancer survive after five years with the disease.(2)

"This study highlights the potential survival benefit of VELCADE in solid tumors beyond hematological cancers," said Robert Tepper, M.D., President, Research & Development, Millennium. "It also aligns with our aggressive strategy to pursue the benefits of VELCADE in lung cancer."

Based on these results and other positive response rates in ongoing trials, Millennium and co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) are moving forward with a clinical program to evaluate the benefits of VELCADE based regimens in treating NSCLC. The companies recently initiated two randomized Phase II studies of VELCADE, one in combination with pemetrexed and the other in combination with erlotinib, in patients with advanced or metastatic NSCLC who have failed prior chemotherapy treatment.

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 174,470 new cases will be diagnosed in 2006. Of those, 87 percent will be NSCLC cases. 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 60 percent. However, it is estimated that only 15 percent of people with lung cancer are diagnosed at an early stage.(3)


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 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.

In 331 patients who were treated with VELCADE in a Phase III multiple myeloma 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 decrease (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 65 countries worldwide. VELCADE is also approved in the European Union as a treatment at first relapse.

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).

About Millennium

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 candidate products. 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 contributors (2005). Detailed Guide: Lung Cancer - Non-Small Cell: What is Non-Small Cell Lung Cancer?" http://www.cancer.org/docroot/CRI/conte ... at_Is_Non- Small_Cell_Lung_Cancer.asp?rnav=cri

(2) American Cancer Society contributors (2005). Detailed Guide: Lung- Cancer-Non-Small Cell: What are the key statistics about lung cancer?" Available at http://www.cancer.org/docroot/CRI/conte ... y_Statisti cs_About_Lung_Cancer_15.asp?sitearea.

(3) American Cancer Society, "What is Lung Cancer?" Available at http://www.cancer.org. Accessed on February 10, 2006

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