Millennium: The Takeda Oncology Company reported results from two large, multi-center, randomized Phase III clinical trials of VELCADE® (bortezomib) based combinations for induction therapy, and single-agent maintenance therapy in patients with previously untreated multiple myeloma (MM). These data were presented at the 52nd annual meeting of the American Society of Hematology (ASH), held December 4-7 in Orlando, Florida.

The first study was conducted among 750 previously untreated MM patients and compared VELCADE, doxorubicin and dexamethasone (PAD) induction followed by autologous stem cell transplant (ASCT) and single-agent VELCADE maintenance (every other week for two years) against vincristine, doxorubicin and dexamethasone (VAD) induction followed by ASCT and thalidomide maintenance. These cooperative group data were generated by the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and the German Multiple Myeloma Group (GMMG) and were presented by Pieter Sonneveld, M.D., University Hospital, Rotterdam, The Netherlands on Sunday, December 5.

The second study was conducted in 502 previously untreated MM patients ineligible for high-dose therapy and stem cell transplantation. Patients were randomized to one of three induction combinations: VELCADE and dexamethasone (VcD); VELCADE, thalidomide, dexamethasone (VcTD); or VELCADE, melphalan and prednisone (VcMP), all followed by weekly VELCADE maintenance (four weeks on, one week off) for 25 weeks. These data were presented by Ruben Niesvizky, M.D., Weill Cornell Medical College, New York, NY on Monday, December 6.

"The HOVON/GMMG study in younger, transplant-eligible patients demonstrated the potential impact of VELCADE based induction and maintenance therapy in prolonging progression-free and overall survival," said Nancy Simonian, M.D. Chief Medical Officer, Millennium. "In the UPFRONT study, all three VELCADE based combinations demonstrated high response rates, which were all further increased after maintenance treatment with weekly VELCADE."

HOVON-65/GMMG-HD4 Randomized Phase III Trial Comparing Bortezomib, Doxorubicin, Dexamethasone (PAD) Vs VAD Followed by High-Dose Melphalan (HDM) and Maintenance with Bortezomib or Thalidomide In Patients with Newly Diagnosed Multiple Myeloma (MM) (Abstract #40)

This Phase III trial in 750 previously untreated MM patients with a median age of 57 was conducted by Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON). The updated results, which were presented by Professor Sonneveld showed:

- The overall PFS was longer in the VELCADE arm compared to the VAD- thalidomide arm (median 36 months v 27 months; HR=0.75; p - The overall survival was improved in the VELCADE arm compared to the VAD-thalidomide arm (HR=0.73; p=0.02); the median was not reached

- The complete response/near complete response (CR/nCR) rate was 49 percent in the VELCADE arm and 34 percent in the VAD-thalidomide arm (p