Millennium presents VELCADE Phase III trial data in multiple myeloma at IMW meeting

May 7 2011

Millennium: The Takeda Oncology Company today reported the presentation of results of a randomized Phase III trial that investigated the effect of consolidation with single-agent VELCADE^® (bortezomib) for Injection in newly diagnosed multiple myeloma (MM) patients after autologous stem cell transplant (ASCT). The study showed that consolidation with VELCADE led to significant improvements in response rates and progression-free survival, while the overall survival rate was 87 percent in both arms after a median follow-up of 27 months. These data were presented at the 13^th International Myeloma Workshop, held May 3-6 in Paris, France.

"The improvements in progression free survival with VELCADE consolidation add to the demonstrated overall survival benefit from VELCADE induction and maintenance previously reported at ASH 2010 by the HOVON group," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

Improved Progression-Free Survival (PFS) with bortezomib consolidation after high-dose melphalan (HDM); results of a randomized phase III trial

The study results, which were presented by Ulf-Henrik Mellqvist, M.D., Ph.D., Sahlgrenska University Hospital, Gothenburg, Sweden, showed:

• The median progression-free survival (PFS) measured from the time of randomization was 27 months for patients in the VELCADE arm compared to 20 months for patients in the control group
• Forty-five percent of patients in the VELCADE arm achieved a complete response/near complete response (CR/nCR), compared to 35 percent of patients in the control group (p<0.05)
• The estimated overall survival (OS) was 87 percent in both groups after a median follow-up of 27 months
• Six percent of patients in the VELCADE arm had neuropathic pain of grade 3 or higher, compared with 0.5 percent of patients in the control arm
• Five percent of patients in the VELCADE arm experienced peripheral sensory neuropathy of grade 3 or higher, compared with two percent of patients in the control arm

In this study, 370 patients were randomized to either VELCADE consolidation therapy or no consolidation therapy following ASCT. VELCADE was given in a dose of 1.3 mg/m² twice weekly in a three-week schedule for the first two cycles. In the following four cycles, VELCADE was given once weekly in a four-week schedule for a total of 20 injections over 21 weeks.

Source: Millennium