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Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

SAN FRANCISCO, Dec. 8 /PRNewswire/ -- Millennium: The Takeda Oncology Company today reported updated results from two large, multi-center, randomized Phase III clinical trials of VELCADE based combinations for the induction treatment of transplant-eligible patients with previously untreated multiple myeloma (MM). Prolonged progression-free survival (PFS) was observed in one study comparing VELCADE and dexamethasone (VcD) with vincristine, adriamycin and dexamethasone (VAD), as well as in another study comparing VELCADE, thalidomide and dexamethasone (VcTD) with thalidomide and dexamethasone (TD). These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH), held December 5-9, 2008 in San Francisco, California.

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"VELCADE based combinations continue to deliver high response rates, including complete responses," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "It is impressive to see that this already translates to improved progression-free survival when VELCADE regimens are used in conjunction with high dose therapy and stem cell transplantation."

VELCADE-Dexamethasone versus VAD as Induction Treatment Prior to ASCT in Newly Diagnosed Multiple Myeloma: Updated Results of the IFM2005/01 Trial (ASH/ASCO Joint Symposium)

This 482-patient Phase III trial was conducted by the Intergroupe Francophone du Myelome (IFM) cooperative group and Nantes University Hospital (France). The updated results, which were presented by Professor Harousseau, showed:

    -- The two year PFS was 69 percent in the VcD arm, compared with 60
       percent in the VAD arm (p=0.0115).
    -- Post-induction complete response (CR)/near complete response (nCR)
       rates were 15 percent in the VcD arm, compared with 7 percent in the
       VAD arm (p=0.0035).
    -- After the first performed ASCT, CR/nCR rates were 40 percent in the VcD
       arm, compared with 22 percent in the VAD arm (p=0.0001).
   -- After the first performed ASCT, very good partial response (VGPR) or
      better rates were 61 percent in the VcD arm, compared with 44 percent
      in the VAD arm (p=0.0007).
    -- Thirty-four percent of patients in the VcD arm required a second ASCT,
       compared with 47 percent of patients in the VAD arm.
    -- Serious adverse events were reported in 27 percent of the VcD patients,
       compared with 34 percent of the VAD patients.

"The data from patients treated with VELCADE and dexamethasone prior to transplantation showed significantly longer progression-free survival," said Jean-Luc Harousseau, M.D., Hospital Hotel-Dieu and Principal Investigator of the trial. "We are interested in whether this will translate into extended overall survival for these patients with previously untreated multiple myeloma when the follow-up duration is sufficient."

Patients in the VcD arm received VELCADE at 1.3 mg/m(2) on days 1, 4, 8 and 11 and dexamethasone at 40 mg on days 1 through 4 during cycles 1 through 4 and days 9 through 12 during only the first and second cycles. Patients in the VAD arm received vincristine at 0.4 mg/m(2) and doxorubicin at 9 mg/m(2) on days 1 through 4, and dexamethasone at 40 mg on days 1 through 4 during cycles 1 through 4 and on days 9 through 12 and 17 through 20 during only the first and second cycles.

Superior Complete Response Rate and Progression-Free Survival After Autologous Transplantation with Up-Front VELCADE-Thalidomide-Dexamethasone Compared with Thalidomide-Dexamethasone in Newly Diagnosed Multiple Myeloma (Abstract #158)

In a Phase III study conducted by the Italian Myeloma Network GIMEMA, researchers compared VcTD with TD as induction therapy in preparation for and as consolidation after melphalan-based double ASCT in 460 patients with symptomatic MM. The median follow-up was 15 months.

The updated results, which were presented by Michele Cavo, M.D., Seragnoli Institute of Hematology and Medical Oncology, showed:

-- The two-year PFS was 90 percent in the VcTD arm, compared with 80 percent in the TD arm (p=0.009).

-- After three cycles of induction, CR/nCR rates were 32 percent in the VcTD arm, compared with 12 percent in the TD arm (p<0.001).

-- After the first ASCT, CR/nCR rates were 55 percent in the VcTD arm, compared with 32 percent in the TD arm (p<0.001).

-- After the first ASCT, VGPR or better rates were 76 percent in the VcTD arm, compared with 58 percent in the TD arm (p<0.001).

-- Serious adverse events were recorded in 15 percent of patients in the VcTD arm, compared with 12 percent of those in the TD arm.

Patients in the VcTD arm received 1.3 mg/m(2) of VELCADE on days 1, 4, 8 and 11; 200 mg of thalidomide daily and 40 mg of dexamethasone on days 1, 2, 4, 5, 8, 9, 11 and 12. Patients in the TD arm received 200 mg of thalidomide daily and 40 mg of dexamethasone on days 1 through 4 and 9 through 12 for three 21-day cycles.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the median age of onset is 70 years), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 50,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.


VELCADE is 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 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients with multiple myeloma. VELCADE also is indicated for the treatment of patients with mantle cell lymphoma 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 throughout therapy, cardiac and pulmonary disorders, reversible posterior leukoencephalopathy syndrome, gastrointestinal adverse events, thrombocytopenia, neutropenia, tumor lysis syndrome and hepatic events. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE. Nursing mothers are advised not to breastfeed while receiving 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 new onset of decreased left ventricular ejection fraction has been reported, including reports in patients with no risk factors for decreased left ventricular ejection fraction. There have been reports of acute diffuse infiltrative pulmonary disease of unknown etiology such as pneumonitis, interstitial pneumonia, lung infiltration and Acute Respiratory Distress Syndrome in patients receiving VELCADE. Some of these events have been fatal. There have been reports of Reversible Posterior Leukoencephalopathy Syndrome (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. Cases of acute liver failure have been reported in patients receiving multiple concomitant medications and with serious underlying medical conditions. Patients who are concomitantly receiving VELCADE and drugs that are inhibitors or inducers of cytochrome P450 3A4 should be closely monitored for either toxicities or reduced efficacy. Patients on oral antidiabetic medication while receiving VELCADE should check blood sugar levels frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent VELCADE 1.3 mg/m(2)/dose twice weekly for 2 weeks followed by a 10-day rest period in 1163 patients with previously treated multiple myeloma (N=1008, not including the Phase III, VELCADE plus DOXIL(R) [doxorubicin HCl liposome injection] study) and previously treated mantle cell lymphoma (N=155) were integrated and tabulated. In these studies, the safety profile of VELCADE was similar in patients with multiple myeloma and mantle cell lymphoma.

In the integrated analysis, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy NEC (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), anemia (29%), edema (23%), headache, paresthesia and dysesthesia and headache (each 22%), dyspnea (21%), cough and insomnia (each 20%), rash (18%), arthralgia (17%), neutropenia and dizziness (excluding vertigo) (each 17%), pain in limb and abdominal pain (each 15%), bone pain (14%), back pain and hypotension (each 13%), herpes zoster, nasopharyngitis, upper respiratory tract infection, myalgia and pneumonia (each 12%), muscle cramps (11%), and dehydration and anxiety (each 10%). Twenty percent (20%) of patients experienced at least 1 episode of >/= Grade 4 toxicity, most commonly thrombocytopenia (5%) and neutropenia (3%). A total of 50% of patients experienced serious adverse events (SAEs) during the studies. The most commonly reported SAEs included pneumonia (7%), pyrexia (6%), diarrhea (5%), vomiting (4%), and nausea, dehydration, dyspnea and thrombocytopenia (each 3%).

In the Phase III VELCADE + melphalan and prednisone study, the safety profile of VELCADE in combination with melphalan/prednisone is consistent with the known safety profiles of both VELCADE and melphalan/prednisone. The most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%).

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. ("Takeda", TSE: 4502) in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website,

Editors' Note: This press release is also available under the Media section of the Company's website at:

    Manisha Pai                 Karen Gobler
    (617) 551-7877              (617) 444-1392

SOURCE Millennium: The Takeda Oncology Company
Copyright©2008 PR Newswire.
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