ASH News Daily - Sunday, December 11, 2011 - (Page A-11)

VISIT BOOTH 1629 TO LEARN MORE PROVEN EFFICACY ACROSS KEY ENDPOINTS GREATER TIME TO PROGRESSION INITIAL VISTA † TRIAL ANALYSIS (16.3-MONTH MEDIAN FOLLOW-UP) 20.7 15.0 0 5 10 15 MONTHS VcMP (n=344) MP (n=338) HR=0.54; P=0.000002 ‡ MONTHS Months 20 25 GREATER RESPONSE RATES§ INITIAL VISTA TRIAL ANALYSIS (16.3-MONTH MEDIAN FOLLOW-UP) VcMP (n=344) MP (n=338) P<0.0000000001 2 69% 34% ORR 30% 4% CR (IF-) Adverse Reactions Most commonly reported adverse reactions (incidence ≥30%) in clinical studies include asthenic conditions, diarrhea, nausea, constipation, peripheral neuropathy, vomiting, pyrexia, thrombocytopenia, psychiatric disorders, anorexia and decreased appetite, neutropenia, neuralgia, leukopenia, and anemia. Other adverse reactions, including serious adverse reactions, have been reported Please see Brief Summary for VELCADE on next page. *Melphalan+prednisone. † VISTA: a randomized, open-label, international phase 3 trial (N=682) evaluating the efficacy and safety of VELCADE in combination with MP vs MP in previously untreated multiple myeloma. The primary endpoint was TTP. Secondary endpoints were CR, ORR, PFS, and OS. At a pre-specified interim analysis (median follow-up 16.3 months), VcMP resulted in significantly superior results for TTP, PFS, OS, and ORR. Further enrollment was halted and patients receiving MP were offered VELCADE in addition. VELCADE (Vc) in combination with MP. Responses were based on criteria established by the European Group for Blood and Marrow Transplantation (EBMT). CR required 100% disappearance of the original myeloma protein from blood and urine on at least 2 determinations 6 weeks apart by immunofixation (IF-), absence of plasmacytoma, <5% plasma cells in the bone marrow, and stable bone disease.1 ‡ § References: 1. Bladé J, Samson D, Reece D, et al; Myeloma Subcommittee of the EBMT Chronic Leukaemia Working Party and the Myeloma Working Committee of the International Bone Marrow Transplant Registry and Autologous Blood and Marrow Transplant Registry. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Br J Haematol. 1998;102:1115-1123. 2. Data on file 42, Millennium Pharmaceuticals, Inc. For Patient Assistance Information or Reimbursement Assistance, call 1-866-VELCADE (835-2233), Option 2, or visit VELCADE.com 11/10/11 2:20 PM 

Table of Contents for the Digital Edition of ASH News Daily - Sunday, December 11, 2011

ASH News Daily - Sunday, December 11, 2011

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