Phase III Trial of VELCADE(R) (Bortezomib) for Injection Showed Dramatic Fourfold Increase in Complete Remission Rates When Combined With the Most Commonly Used U.S. Regimen in Front-Line Multip...(nofixation positive and negative) ...),Health

positive and negative) rate of 36 percent compared to 9 percent in the

TD arm (p<0.001)

-- Following transplantation, the VcTD arm demonstrated a complete

remission (CR, including immunofixation positive and negative) rate of

57 percent compared to 28 percent in the TD arm (p<0.001)

-- Successful stem cell mobilization occurred in more than 90 percent of

patients in both arms

"We are excited to see that the VELCADE combination continues to improve the complete remission rates of commonly used regimens to deliver significantly better results for patients," said Nancy Simonian, M.D., Chief Medical Officer, Millennium. "This is one of the three Phase III front-line multiple myeloma trials presented at ASH that clearly establishes VELCADE as a leading therapy for patients with previously untreated multiple myeloma."

Patients in the VcTD arm received VELCADE at 1.3 mg/m(2) on days 1, 4, 8 and 11; dexamethasone at 40 mg each day of and after VELCADE; thalidomide at 200 mg daily on a 21-day cycle for three cycles. Patients in the TD arm received dexamethasone at 40 mg on days 1 through 4 and 9 through 12 of every 21-day cycle and thalidomide up to 200 mg on a 21-day cycle for three cycles. The primary endpoint of the trial is CR to induction therapy and secondary endpoints include post-transplant CR, time-to-disease progression (TTP), event-free survival (EFS), overall survival (OS) and toxicity. VcTD was a well tolerated induction regimen with the incidence of grade two and grade three adverse events similar in each arm.

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 of age), recent statistics indicate both increasing incidence and younger age of onset. In the U.S., more than 55,000 individuals have MM and 20,000 new cases are diagnosed
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