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VELCADE(R) (Bortezomib) for Injection Shows Promising Activity in Two Phase II Studies of Patients With Non-Hodgkin's Lymphoma

Posted on: Tuesday, 1 February 2005, 09:00 CST

CAMBRIDGE, Mass., Feb. 1 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. announced results from two clinical trials with VELCADE in patients with non-Hodgkin's lymphoma (NHL) published today in the Journal of Clinical Oncology (JCO). The data, in part presented at the 2004 American Society of Clinical Oncology (ASCO) meeting, were findings from an ongoing phase II National Cancer Institute-sponsored study and final results from a phase II investigator initiated study examining the potential role of VELCADE in patients with various forms of NHL.

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

"We are very encouraged by the potential VELCADE demonstrated in these patients with aggressive and indolent lymphoma," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "These results support our goal of broadly exploring the use of VELCADE in a number of hematological cancers, and we look forward to presenting additional lymphoma data during the first half of this year."

Millennium and Johnson & Johnson Pharmaceutical Research and Development, L.L.C. are investigating VELCADE in both hematologic and solid tumors in trials throughout the U.S. and Europe.

In the National Cancer Institute-sponsored study led by Owen A. O'Connor, M.D., Ph.D., of Memorial Sloan-Kettering Cancer Center in New York, NY, patients with follicular, mantle cell, small lymphocytic and marginal zone lymphoma received single-agent VELCADE at 1.5 mg/m2 twice weekly for two weeks every 21 days. There was no upper limit on planned therapy and treatment could continue as long as evidence of clinical benefit without excess toxicity. To be eligible for the study, patients must have received no more than three prior lines of therapy. Results included:

* A 58 percent overall response rate was observed in 24 evaluable patients

of the 26 enrolled; patients received a median of four cycles of

therapy;

* Seven of the nine evaluable patients with follicular lymphoma achieved

objective remissions of their disease:

- One patient had a durable complete response;

- One patient had an unconfirmed complete response;

- Five patients had partial responses; and

- All responses were reported to be durable and ranged from three to 20

months with responses reported to be ongoing.

* A 50 percent overall response rate was seen in the 10 evaluable patients

with mantle cell lymphoma:

- Five achieved major remissions;

- Four experienced stable disease; and

- All responses reported to be durable and ranged from six to 19 months

with the median duration of response not reached.

* The two patients with nodal marginal zone lymphoma responded rapidly to

bortezomib and duration of their responses to date exceed eight and 11

months; and

* Adverse events observed were generally manageable and included

thrombocytopenia, lymphopenia, neuropathy, hypoatremia, hypokalemia, and

prothrombin time.

"NHL is the most common hematologic cancer and the fifth most common cancer diagnosed in the United States each year, and since these lymphomas are not curable with standard treatment there is a growing need for new therapies," said Dr. O'Connor, Head of the Laboratory of Experimental Therapeutics for the Lymphoproliferative Malignancies at Memorial Sloan- Kettering Cancer Center. "These studies provide evidence of promising activity of bortezomib in patients with both indolent and aggressive types of NHL that failed multiple prior therapies, and the studies are now being expanded to multiple centers to accumulate further experience of the efficacy of bortezomib against these lymphomas."

In a separate, second study included in JCO, led by Andre Goy, M.D., of the University of Texas M.D. Anderson Cancer Center, studied patients 16 years of age or older, with relapsed or refractory B-cell NHL. There was no limitation in the number of prior systemic cytotoxic regimens or immunotherapy. Patients were stratified into two arms, one mantle cell lymphoma and one B-cell lymphomas. Patients received single agent VELCADE(R) (bortezomib) for Injection at 1.5 mg/m2 twice weekly for two weeks every 21 days for up to six cycles. Results included:

* In the mantle cell lymphoma group, 12 of 29 (41 percent) evaluable

patients responded to VELCADE treatment. Specifically:

- Six patients achieved complete responses;

- Six patients achieved partial responses;

- Approximately 80 percent of patients retained their response at six

months; and

- The median time to progression has not been reached with a median

follow-up of 8.5 months.

* In the B-cell lymphoma group, 4 of 21 (19 percent) evaluable B-cell

lymphoma patients responded to VELCADE treatment with a median of two

cycles of therapy administered.

- This patient population was heavily pre-treated, and had received an

average of four prior therapies (with a range of one to 12).

* Adverse events observed were generally manageable and included

thrombocytopenia, gastrointestinal events, fatigue, neutropenia,

peripheral neuropathy, dizziness, and myalgia.

"Patients with MCL could be viewed as having the worst prognosis of all forms of lymphoma and are candidates for innovative therapy," wrote Richard Fisher, M.D., James P. Wilmot Cancer Center, University of Rochester Medical Center, in the accompanying JCO editorial, entitled Mantle Cell Lymphoma: At Last, Some Hope for Successful Innovative Treatment Strategies. "The study results in MCL patients are remarkably consistent and quite exciting. VELCADE is clearly active in follicular lymphoma and its utility will need to be better defined in larger trials."

About non-Hodgkin's lymphoma

Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer and the fifth leading cause of cancer death in U.S. There are approximately 54,000 new cases diagnosed per year, it is attributed to 19,000 deaths and is the second fastest growing form of cancer in the U.S. The prevalence of NHL is approximately 360,000 patients, 96,000 patients with follicular lymphoma and 11,000 with mantle cell lymphoma. According to the American Cancer Society, the incidence of NHL has more than doubled since the 1970's. The average age of diagnosis is between 55 and 60.

About VELCADE(R) (bortezomib) for Injection

VELCADE is approved for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. The effectiveness of VELCADE is based on response rates. There are no controlled trials demonstrating a clinical

benefit, such as improvement in survival. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.

VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan.

Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, orthostatic hypotension, congestive heart failure, gastrointestinal adverse events, thrombocytopenia, and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.

In 228 patients who were treated with VELCADE 1.3 mg/m2/dose in phase II studies, the most commonly reported adverse events were asthenic conditions (65%), nausea (64%), diarrhea (51%), decreased appetite including anorexia (43%), constipation (43%), thrombocytopenia (43%), peripheral neuropathy (37%), pyrexia (36%), vomiting (36%), and anemia (32%). Fourteen percent of patients experienced at least one episode of Grade 4 toxicity, with the most common toxicities being thrombocytopenia (3%) and neutropenia (3%). A total of 113 (50%) of the 228 patients experienced Serious Adverse Events (SAEs) during studies. The most commonly reported SAEs included pyrexia (7%), pneumonia (7%), diarrhea (6%), vomiting (5%), dehydration (5%), and nausea (4%).

For more information about VELCADE(R) (bortezomib) for Injection clinical trials, patients and physicians can contact the Millennium Medical Product Information Department at 1-(866)-VELCADE.

About The Company

Millennium Pharmaceuticals, Inc., a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, co- promotes INTEGRILIN(R) (eptifibatide) Injection, a market-leading cardiovascular product, and has a robust clinical development pipeline of product candidates. The Company's research, development and commercialization activities are focused in three therapeutic areas: oncology, cardiovascular, and inflammation. By applying its knowledge of the human genome, its understanding of disease mechanisms, and its industrialized drug discovery platform, the Company is seeking to develop breakthrough products.

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; 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.

Editor's Note: This release is available under the Media section on the Company's website at http://www.millennium.com/.

Contacts:

Adriana Jenkins (media) Kyle Kuvalanka (investor)

(617) 761-6996 (617) 761-4734

Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19991220/MLNMLOGOAP Archive: http://photoarchive.ap.org/PRN Photo Desk, photodesk@prnewswire.com

Millennium Pharmaceuticals, Inc.

CONTACT: Adriana Jenkins (media), +1-617-761-6996, or Kyle Kuvalanka(investor), +1-617-761-4734, both of Millennium Pharmaceuticals, Inc.

Web site: http://www.millennium.com/

Company News On-Call: http://www.prnewswire.com/comp/114562.html

Source: PRNewswire-FirstCall

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