ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. today announced results of a clinical study that showed the efficacy of single-agent VELCADE in the treatment of relapsed or refractory mantle cell lymphoma. These Phase II data were presented at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta, June 2-6, 2006. Overall response rate, including complete responses, was 33 percent with a median duration of response of 9.2 months. These data are anticipated to be the basis for the Company's submission of a supplemental new drug application (sNDA) shortly.
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"These results may offer new hope for the management of mantle cell lymphoma, which represents the most challenging subtype of lymphoma," said Andre Goy, M.D., Chief of The Division of Lymphoma, The Cancer Center at Hackensack University Medical Center in Hackensack, N.J. "Moreover, they reinforce the safety and efficacy observed in multiple other Phase II studies of VELCADE which showed its potential to become a new standard of care for relapsed patients."
VELCADE in Relapsed or Refractory Mantle Cell Lymphoma (MCL): Results of the PINNACLE Study (Abstract 7512)
The Phase II prospective, single-arm study led by Drs. Richard Fisher and Andre Goy assessed the safety and efficacy of VELCADE in 155 patients with relapsed or refractory MCL with a maximum of two prior therapies. Patients received single-agent VELCADE 1.3mg/m2 twice weekly for two weeks every 21 days for up to one year. Patients achieving complete response (CR), unconfirmed complete response (CRu) or partial response (PR) received a medina of eight treatment cycles and all patients on study received a median of four cycles. Study results included:
* Overall response rate of 33 percent (CR + CRu + PR)
* Complete response rate of 8 percent (CR+CRu)
* Median duration of response (DOR) of 9.2 months, 13.5 months in
patients achieving complete response
* Median time to progression (TTP) of 6.2 months
* Median treatment-free interval of 13.8 months in patients achieving a
complete response
* Treatment well tolerated. The most common non-hematologic adverse
events were fatigue, gastrointestinal events and peripheral neuropathy.
Hematologic toxicities were consistent with those previously seen with
VELCADE.
These results contribute to the growing body of evidence supporting VELCADE in the treatment of relapsed or refractory MCL, including four other Phase II clinical trials showing overall response rates of 30 to 40 percent. Millennium anticipates submitting a sNDA for relapsed MCL with the Food and Drug Administration (FDA) shortly. Earlier this year, the Company, together with its co-development partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), initiated a Phase III clinical trial of VELCADE in combination with rituximab in patients with relapsed or refractory follicular lymphoma, another subtype of non-Hodgkin's lymphoma.
"This study represents a major advancement in the treatment of mantle cell lymphoma and, as planned, we will be seeking FDA approval," said Robert Tepper, M.D., President, Research & Development, Millennium. "The results also provide further evidence of the potential clinical benefits of VELCADE in treating hematological cancers beyond multiple myeloma."
About Non-Hodgkin's Lymphoma
Non-Hodgkin's lymphoma (NHL) is the most common hematological cancer, the fifth leading cause of cancer death and the second fastest growing form of cancer in the U.S.(1) The prevalence of NHL is approximately 400,000 patients, 77,000 patients with follicular lymphoma and 11,000 with mantle cell lymphoma. There are approximately 56,400 new cases of NHL diagnosed per year, and 19,000 deaths are attributed to the disease annually(2),(3).
Mantle cell lymphoma is an aggressive, rapidly progressive subtype of non-Hodgkin's lymphoma that is not curable with standard therapy. Because there is no generally accepted treatment approach and options often are limited, there is a growing need for new therapies.
About VELCADE
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 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 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 http://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(R) (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.
This press release is also available under the Media section of the Company's website at: http://www.millennium.com/.
(1) 2005, American Cancer Society, Inc., Surveillance Research.
(2) SEER, SARGA, and Decision Resources (for growth rate) data.
(3) Federico et al., BLOOD 95(3): 783-789; 2000.
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