VELCADE(R) (Bortezomib) for Injection Based Treatment Delivers Impressive Complete Response and Survival in Patients With Newly Diagnosed Multip...(ty of VELCADE to deliver consistently hi...),Health

Date:5/31/2008

ty of VELCADE to deliver consistently high complete remission rates that lead to improved clinical benefit, including survival," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "The updated results from the IFM, combined with the pending approval by the FDA, bring us one step further in establishing VELCADE as the foundation of therapy for patients with newly diagnosed multiple myeloma."

Results from this large clinical trial were presented by Professor Harousseau. The VcD arm versus the VAD arm showed:
-- 95 percent of patients were alive at one year compared to

92 percent

-- A CR rate of 19 percent compared to 8 percent as induction therapy

(p=0.0004)

-- A CR rate of 35 percent compared to 23 percent post-transplantation

(p=0.0063)

-- 63 percent of patients did not require a second transplantation

compared to 44 percent (p<0.0001)

Patients in the VcD arm received four cycles of VELCADE at 1.3 mg/m2 on days 1, 4, 8 and 11 of a 21-day cycle. Patients also received dexamethasone at 40 mg on days 1 through 4 during cycles one through four and on days 9 through 12 during cycles one and two only. The patients in the VAD arm were treated for four 28-day cycles with vincristine at 0.4 mg/m2 on days 1 through 4; adriamycin at 9 mg/m2 on days 1 through 4; and dexamethasone at 40 mg on days 1 through 4, days 9 through 12 during cycles one through four and on days 17 through 20 during cycles one and two only. Half of the patients in each arm received dexamethasone, cyclophosphamide, etoposide and cisplatinum (DCEP) consolidation pre-transplant. VcD was well tolerated with the incidence of grade 3 and grade 4 adverse events similar in each arm. Serious adverse events were slightly lower with VcD.

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 onse
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SOURCE Millennium Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved

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