VELCADE Successful In Patients With Previously Untreated Multiple Myeloma

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Millennium: The Takeda Oncology Company today reported updated results based on extended follow up of patients from the large, international Phase III VISTA trial showing continued survival improvement for patients with previously untreated multiple myeloma given VELCADE, melphalan and prednisone (VcMP).

The VELCADE combination demonstrated consistent efficacy in all patient sub-groups, including those with poor prognostic characteristics, such as advanced age, poor risk cytogenetics and renal impairment.

"The ultimate goal in treating multiple myeloma is to prolong the patient's life," said Professor Jesus San-Miguel, M.D., Ph.D., Hospital Universitario de Salamanca and Principal Investigator of the trial. "The follow-up data from the VISTA study showed that the addition of VELCADE to melphalan and prednisone continued to demonstrate a long-term survival advantage for patients with previously untreated multiple myeloma."

The VISTA trial enrolled 682 patients with previously untreated multiple myeloma ineligible for stem cell transplantation. The first interim analysis was presented at ASH 2007. Data with a median follow up of 25.9 months were presented at this year's ASH meeting. In addition, a detailed analysis evaluated the impact of subsequent therapy on the overall survival (OS) results. The updated results, which were presented by Professor San-Miguel, included:

* Thirty-six percent reduced risk of death in the VcMP arm, compared with the MP arm (hazard ratio =0.644, p=0.0032; median survival not yet reached in either arm).

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* This OS advantage was maintained despite 43 percent of MP patients receiving VELCADE.

* Treatment-free interval (TFI) of 16.6 months in the VcMP arm, compared with 8.4 months in the MP arm (p<0.00001).

* A subset analysis of VcMP treated patients with poor prognostic features, including age >75 years or creatinine clearance <60 mL/min. or high-risk cytogenetics, achieved comparable overall survival to that of patients without negative prognostic features (p<0.06).

* No new or unexpected adverse events were reported in the extended follow up analysis.

"This update demonstrates that the use of VELCADE upfront delivers an improvement in overall survival, which is maintained over time. Importantly, this benefit was observed regardless of subsequent therapy," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

Patients in the VcMP arm of the study received nine 6-week cycles of VELCADE at 1.3 mg/m (days 1, 4, 8, 11, 22, 25, 29 and 32 in cycles 1 through 4 and days 1, 8, 22 and 29 in cycles 5 through 9) with melphalan 9 mg/m and prednisone 60 mg/m (days 1 through 4 in cycles 1 through 9), or melphalan plus prednisone, in the same dose and schedule administered to the patients in the VcMP arm. Patients remained on VcMP therapy for a median of 46 weeks (eight cycles) out of the planned nine cycles versus 39 weeks (seven cycles) with melphalan and prednisone.

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